The effect of augmented speech-language therapy delivered by telerehabilitation on poststroke aphasia—a pilot randomized controlled trial

Objective: Pilot a definitive randomized controlled trial of speech-language telerehabilitation in poststroke aphasia in addition to usual care with regard to recruitment, drop-outs, and language effects. Design: Pilot single-blinded randomized controlled trial. Setting: Telerehabilitation delivered from tertiary rehabilitation center to participants at their home or admitted to secondary rehabilitation centers. Subjects: People with naming impairment due to aphasia following stroke. Intervention: Sixty-two participants randomly allocated to 5 hours of speech and language telerehabilitation by videoconference per week over four consecutive weeks together with usual care or usual care alone. The telerehabilitation targeted functional, expressive language. Main measures: Norwegian Basic Aphasia Assessment: naming (primary outcome), repetition, and auditory comprehension subtests; Verb and Sentence Test sentence production subtest and the Communicative Effectiveness Index at baseline, four weeks, and four months postrandomization. Data were analyzed by intention to treat. Results: No significant between-group differences were seen in naming or auditory comprehension in the Norwegian Basic Aphasia Assessment at four weeks and four months post randomization. The telerehabilitation group ( n = 29) achieved a Norwegian Basic Aphasia Assessment repetition score of 8.9 points higher ( P = 0.026) and a Verb and Sentence Test score 3 points higher ( P = 0.002) than the control group ( n = 27) four months postrandomization. Communicative Effectiveness Index was not significantly different between groups, but increased significantly within both groups. No adverse events were reported. Conclusion: Augmented telerehabilitation via videoconference may be a viable rehabilitation model for aphasia affecting language outcomes poststroke. A definitive trial with 230 participants is needed to confirm results.

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Evaluation of a collaborative protocolized approach by community pharmacies and general medical practitioners for an Australian minor ailments scheme: study protocol for a cluster-randomized controlled trial (Preprint)

10.2196/preprints.13973 ◽

2019 ◽

Author(s):

Sarah Dineen-Griffin ◽

Victoria Garcia Cardenas ◽

Kylie Williams ◽

Shalom Isaac Benrimoj

Keyword(s):

Randomized Controlled Trial ◽

Usual Care ◽

Controlled Trial ◽

Self Care ◽

Cluster Randomized Controlled Trial ◽

Control Group ◽

Community Pharmacies ◽

Randomized Controlled ◽

Minor Ailments ◽

Cluster Randomized

BACKGROUND Internationally, governments have been investing in supporting pharmacists to take on an expanded role to support self-care for health system efficiency. There is consistent evidence that minor ailment schemes (MAS) promote efficiencies within the healthcare system. The cost savings and health outcomes demonstrated in the UK and Canada opens up new opportunities for pharmacists to effect sustainable changes through MAS delivery in Australia. OBJECTIVE This trial is evaluating the clinical, economic and humanistic impact of an Australian minor ailments service (AMAS), compared with usual pharmacy care in a cluster-randomized controlled trial in Western Sydney, Australia. METHODS The cluster-randomized controlled trial design has an intervention and a control group, comparing individuals receiving a structured intervention with those receiving usual care for specific common ailments. Participants will be community pharmacies, general practices and patients located in Western Sydney Primary Health Network region. 30 community pharmacies will be randomly assigned to either intervention or control group. Each will recruit 24 patients seeking, aged 18 years or older, presenting to the pharmacy in person with a symptom-based or product-based request for one of the following ailments (reflux, cough, common cold, headache (tension or migraine), primary dysmenorrhoea and low back pain). Intervention pharmacists will deliver protocolized care to patients using clinical treatment pathways with agreed referral points and collaborative systems boosting clinician-pharmacist communication. Patients recruited in control pharmacies will receive usual care. The co-primary outcomes are rates of appropriate use of nonprescription medicines and rates of appropriate medical referral. Secondary outcomes include self-reported symptom resolution, time to resolution of symptoms, health services resource utilization and EQ VAS. Differences in the primary outcomes between groups will be analyzed at the individual patient level accounting for correlation within clusters with generalized estimating equations. The economic impact of the model will be evaluated by cost analysis compared with usual care. RESULTS The study began in July 2018. At the time of submission, 30 community pharmacies have been recruited. Pharmacists from the 15 intervention pharmacies have been trained. 27 general practices have consented. Pharmacy patient recruitment began in August 2018 and is ongoing and monthly targets are being met. Recruitment will be completed March 31st, 2019. CONCLUSIONS This study may demonstrate the utilization and efficacy of a protocolized intervention to manage minor ailments in the community, and will assess the clinical, economic and humanistic impact of this intervention in Australian pharmacy practice. Pharmacists supporting patient self-care and self-medication may contribute greater efficiency of healthcare resources and integration of self-care in the health system. The proposed model and developed educational content may form the basis of a MAS national service, with protocolized care for common ailments using a robust framework for management and referral. CLINICALTRIAL Registered with Australian New Zealand Clinical Trials Registry (ANZCTR) and allocated the ACTRN: ACTRN12618000286246. Registered on 23 February 2018.

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Effects of Monopolar Dielectric Radiofrequency Signals on the Symptoms of Fibromyalgia: A Single-Blind Randomized Controlled Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph17072465 ◽

2020 ◽

Vol 17 (7) ◽

pp. 2465

Author(s):

Alfonso Javier Ibáñez-Vera ◽

Jerónimo Carmelo García-Romero ◽

José Ramón Alvero-Cruz ◽

Rafael Lomas-Vega

Keyword(s):

Randomized Controlled Trial ◽

Usual Care ◽

Sham Group ◽

Controlled Trial ◽

Depression Scale ◽

Physical Factor ◽

Control Group ◽

Local Pain ◽

Randomized Controlled ◽

Experimental Group

Monopolar dielectric radiofrequency (MDR) is a non-invasive treatment for pain based on the local application of electromagnetic signals. The study’s goal was to analyze the effects of MDR on the symptoms of fibromyalgia. For this aim, a randomized controlled trial was conducted on 66 female participants (aged 47 ± 17.7) diagnosed with fibromyalgia. Participants were randomly allocated to either an experimental group (n = 23), which received eight 20-minute sessions of MDR; a sham group, which received the same number of sessions of a sham MDR therapy (n = 22); or a control group (n = 21), which received usual care. The outcome variables included pain measured by the visual analogue scale (VAS), score on the hospital anxiety and depression scale (HADS) and quality of life measured by the combined index of fibromyalgia severity (ICAF). A large effect size was observed for the local pain (R2 = 0.46), total ICAF (R2 = 0.42) and ICAF physical factor scores (R2 = 0.38). Significant mean differences were found for the local pain (p = 0.025) and ICAF physical factor (p = 0.031) scores of the experimental group in comparison with the sham group. No statistically significant differences between groups were found in HADS. In conclusion, MDR is more effective than either sham treatment or usual care in the short-term improvement of pain and the physical wellbeing of participants with fibromyalgia.

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Effectiveness of spiritual care using spiritual pain assessment sheet for advanced cancer patients: A pilot non-randomized controlled trial

Palliative & Supportive Care ◽

10.1017/s1478951518000901 ◽

2019 ◽

Vol 17 (1) ◽

pp. 46-53

Author(s):

Kaori Ichihara ◽

Sayako Ouchi ◽

Sachiko Okayama ◽

Fukiko Kinoshita ◽

Mitsunori Miyashita ◽

...

Keyword(s):

Clinical Trial ◽

Randomized Controlled Trial ◽

Usual Care ◽

Pain Assessment ◽

Spiritual Care ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Assessment Sheet

AbstractObjectiveTo obtain preliminary knowledge to design a randomized controlled trial to clarify the effects of spiritual care using the Spiritual Pain Assessment Sheet (SpiPas).MethodThe study was designed as a nonrandomized controlled trial. The study took place between January 2015 and July 2015 in a hematology and oncology ward and two palliative care units in Japan. Among 54 eligible patients with advanced cancer, 46 were recruited (24 in the control group vs. 22 in the intervention group). The intervention group received spiritual care using SpiPas and usual care; the control group received usual care. The primary outcome was the Functional Assessment of Chronic Illness Therapy-Spiritual (FACIT-Sp). The secondary outcomes were the Hospital Anxiety and Depression Scale (HADS) and Comprehensive Quality of Life Outcome (CoQoLo).ResultA total of 33 (72%) and 23 (50%) patients completed 2- and 3-week follow-up evaluations, respectively. The differences in the changes during 2 weeks in total scores of FACIT-Sp and HADS were significant (95% confidence intervals, 3.65, 14.4, p < 0.01; –11.2 to –1.09, p = .02, respectively). No significant changes were observed in the total score of CoQoLo.Significance of resultsSpiritual care using the SpiPas might be useful for improving patient spiritual well-being. This controlled clinical trial could be performed and a future clinical trial is promising if outcomes are obtained within 2 weeks.

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A randomized controlled trial of a brief educational and psychological intervention for patients presenting to a cardiac clinic with palpitation

Psychological Medicine ◽

10.1017/s0033291702005536 ◽

2002 ◽

Vol 32 (4) ◽

pp. 699-706 ◽

Cited By ~ 11

Author(s):

R. MAYOU ◽

D. SPRIGINGS ◽

J. BIRKHEAD ◽

J. PRICE

Keyword(s):

Randomized Controlled Trial ◽

Usual Care ◽

Educational Intervention ◽

Psychological Intervention ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Number Needed To Treat ◽

Treatment Needs ◽

Randomized Controlled

Background. We sought to determine whether a brief psycho-educational intervention reduced disability in patients with benign palpitation.Method. In a pragmatic randomized controlled trial within a cardiology clinic at a district general hospital, 80 consecutive patients diagnosed as having benign palpitation – either palpitation due to awareness of extrasystoles or sinus rhythm – with associated distress or disability were randomized to an intervention group (usual care plus nurse-delivered intervention based on cognitive-behavioural principles) or to a control group (usual care). Principal outcome was difference in proportion of participants with good or excellent researcher-rated activity levels at 3 months. Subsidiary outcomes were self-rated symptoms, distress and disability, researcher-rated unmet treatment needs.Results. The principal outcome showed a statistically and clinically significant benefit for the intervention group, with a number needed to treat of 3 (95% CIs 2 to 7). All but one subsidiary outcomes also showed a difference in favour of the intervention group, and several differences reached statistical significance. Significantly more of the control group had unmet treatment needs at 3 months.Conclusions. A brief, nurse-delivered, psycho-educational intervention, was an effective treatment for benign palpitation. Further evaluation, including assessment of cost-effectiveness, is needed. The findings have application to the care of patients presenting with other types of ‘unexplained’ medical symptoms.

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Efficacy Of A Multidimensional Versus Usual Care Physiotherapy On Pain And Electroencephalography (EEG) Spectrum In Chronic Nonspecific Low Back Pain: Study Protocol For A Randomized Controlled Trial

10.21203/rs.3.rs-249100/v1 ◽

2021 ◽

Author(s):

Sanaz Bemani ◽

Shohreh Noorizadeh Dehkordi ◽

Javad Sarrafzadeh ◽

Saeed Talebian ◽

Reza Salehi ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Low Back Pain ◽

Back Pain ◽

Usual Care ◽

Controlled Trial ◽

Biomechanical Model ◽

Clinical Findings ◽

Control Group ◽

Low Back ◽

Randomized Controlled

Abstract Background: Non-specific chronic low back pain (NSCLBP) is a major public health and global socioeconomic burden associated with a complex interplay of biopsychosocial factors. Despite scientific signs of progress, treatment of NSCLBP often tends to stick to a biomechanical model, without targeting psychological and social factors. To enhance clinical efficacy of usual physiotherapy for NSCLBP, the development of clinical strategies is to be pursued. This study aims to assess the effectiveness of multidimensional physiotherapy based on biopsychosocial approach compared to usual care physiotherapy, on clinical findings and Electroencephalography spectrum in non-specific chronic low back pain.Methods: This study is a triple-blind, two-arm (1:1) randomized controlled trial with a 4-months follow-up. 70 NSCLBP patients will be randomly allocated to either the experimental (multidimensional physiotherapy) or the active control group (usual physiotherapy), each group will receive 6-weeks of physiotherapy. The main outcome is pain and secondary outcomes are brain function, quality of life, disability, lumbar flexion range of motion and psychosocial correlates. Assessment will be performed at baseline, post-treatment and at 1- and 4-months follow-up.Discussion: Findings may provide evidence on the effectiveness of multidimensional physiotherapy on clinical findings and brain characteristics and might provide evidence towards showing the role of brain and biopsychosocial factors on chronic pain.Trial registration: ClinicalTrials.gov Identifier: NCT04270422, Registered 17 February 2020, https://clinicaltrials.gov/ct2/show/NCT04270422?term=NCT04270422&draw=2&rank=1IRCT Identifier: IRCT20140810018754N11

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Evaluation of a Collaborative Protocolized Approach by Community Pharmacists and General Medical Practitioners for an Australian Minor Ailments Scheme: Protocol for a Cluster Randomized Controlled Trial

JMIR Research Protocols ◽

10.2196/13973 ◽

2019 ◽

Vol 8 (8) ◽

pp. e13973 ◽

Cited By ~ 4

Author(s):

Sarah Dineen-Griffin ◽

Victoria Garcia-Cardenas ◽

Kris Rogers ◽

Kylie Williams ◽

Shalom Isaac Benrimoj

Keyword(s):

Randomized Controlled Trial ◽

Usual Care ◽

Controlled Trial ◽

Self Care ◽

Control Group ◽

Community Pharmacies ◽

Randomized Controlled ◽

Minor Ailments ◽

General Practices ◽

Cluster Randomized

Background Internationally, governments have been investing in supporting pharmacists to take on an expanded role to support self-care for health system efficiency. There is consistent evidence that minor ailment schemes (MASs) promote efficiencies within the health care system. The cost savings and health outcomes demonstrated in the United Kingdom and Canada open up new opportunities for pharmacists to effect sustainable changes through MAS delivery in Australia. Objective This trial aims to evaluate the clinical, economic, and humanistic impact of an Australian Minor Ailments Service (AMAS) compared with usual pharmacy care in a cluster randomized controlled trial (cRCT) in Western Sydney, Australia. Methods The cRCT design has an intervention group and a control group, comparing individuals receiving a structured intervention (AMAS) with those receiving usual care for specific health ailments. Participants will be community pharmacies, general practices, and patients located in Western Sydney Primary Health Network (WSPHN) region. A total of 30 community pharmacies will be randomly assigned to either intervention or control group. Each will recruit 24 patients, aged 18 years or older, presenting to the pharmacy in person with a symptom-based or product-based request for one of the following ailments: reflux, cough, common cold, headache (tension or migraine), primary dysmenorrhea, or low back pain. Intervention pharmacists will deliver protocolized care to patients using clinical treatment pathways with agreed referral points and collaborative systems boosting clinician-pharmacist communication. Patients recruited in control pharmacies will receive usual care. The coprimary outcomes are rates of appropriate recommendation of nonprescription medicines and rates of appropriate medical referral. Secondary outcomes include self-reported symptom resolution, health services resource utilization, and EuroQoL Visual Analogue Scale. Differences in primary outcomes between groups will be analyzed at the individual patient level accounting for correlation within clusters with generalized estimating equations. The economic impact of the model will be evaluated by cost-utility and cost-effectiveness analysis compared with usual care. Results The study began in July 2018. Thirty community pharmacies were recruited. Pharmacists from the 15 intervention pharmacies were trained. A total of 27 general practices consented. Pharmacy patient recruitment began in August 2018 and was completed on March 31, 2019. Conclusions This study may demonstrate the efficacy of a protocolized intervention to manage minor ailments in the community and will assess the clinical, economic, and humanistic impact of this intervention in Australian pharmacy practice. Pharmacists supporting patient self-care and appropriate self-medication may contribute to greater efficiency of health care resources and integration of self-care in the health system. The proposed model and developed educational content may form the basis of a national MAS service in Australia, using a robust framework for management and referral for common ailments. Trial Registration Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12618000286246; http://www.anzctr.org.au/ACTRN12618000286246.aspx International Registered Report Identifier (IRRID) DERR1-10.2196/13973

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Feasibility of modifying the hospital environment to reduce the length of amnesia after traumatic brain injury: a pilot randomized controlled trial

International Journal for Quality in Health Care ◽

10.1093/intqhc/mzab044 ◽

2021 ◽

Vol 33 (1) ◽

Author(s):

Natasha A Lannin ◽

Claire Galea ◽

Megan Coulter ◽

Russell Gruen ◽

Laura Jolliffe ◽

...

Keyword(s):

Traumatic Brain Injury ◽

Randomized Controlled Trial ◽

Brain Injury ◽

Usual Care ◽

Acute Care ◽

Controlled Trial ◽

Hospital Environment ◽

Control Group ◽

Care Hospital ◽

Randomized Controlled

Abstract Background Reorientation programmes have been an important component of neurotrauma rehabilitation for adults who suffer from post-traumatic amnesia (PTA) after traumatic brain injury (TBI); however, research testing the efficacy of acute programmes is limited. Objective This study aimed to determine if it is feasible to provide a standardized environmental reorientation programme to adults suffering from PTA after TBI in an acute care hospital setting, and whether it is likely to be beneficial. Methods We conducted a randomized controlled trial with concealed allocation and intention-to-treat analysis. A total of 40 participants suffering from PTA after TBI were included. The control group received usual care; the experimental group received usual care plus a standardized orientation programme inclusive of environmental cues. The primary outcome measure was time to emergence from PTA measured by the Westmead PTA Scale, assessed daily from hospital admission or on regaining consciousness. Results Adherence to the orientation programme was high, and there were no study-related adverse responses to the environmental orientation programme. Although there were no statistically significant between-group differences in time to emergence, the median time to emergence was shorter for those who received the standardized reorientation programme (9.0 (6.4–11.6) versus 13.0 (4.5–21.5) days). Multivariate analysis showed that the Glasgow Coma Scale (GCS) at scene (P = 0.041) and GCS at arrival at hospital (P = 0.0001) were significant factors contributing to the longer length of PTA. Conclusion Providing an orientation programme in acute care is feasible for adults suffering from PTA after TBI. A future efficacy trial would require 216 participants to detect a between-group difference of 5 days with an alpha of 0.05 and a power of 80%.

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Effect of the Pregnant+ Smartphone App on the Dietary Behavior of Women With Gestational Diabetes Mellitus: Secondary Analysis of a Randomized Controlled Trial (Preprint)

10.2196/preprints.18614 ◽

2020 ◽

Author(s):

Lisa Garnweidner-Holme ◽

Lena Henriksen ◽

Liv Elin Torheim ◽

Mirjam Lukasse

Keyword(s):

Diabetes Mellitus ◽

Randomized Controlled Trial ◽

Usual Care ◽

Controlled Trial ◽

Intervention Group ◽

Dietary Behavior ◽

Smartphone App ◽

Control Group ◽

Food Frequency ◽

Randomized Controlled

BACKGROUND The prevalence of gestational diabetes mellitus (GDM) is increasing worldwide. A healthy diet and stable blood glucose levels during pregnancy can prevent adverse health outcomes for the mother and the newborn child. Mobile health may be a useful supplement to prenatal care, providing women with targeted dietary information concerning GDM. OBJECTIVE We analyzed secondary data from a two-arm, multicentered, nonblinded randomized controlled trial to determine if a smartphone app with targeted dietary information and blood glucose monitoring had an effect on the dietary behavior of women with GDM. METHODS Women with a 2-hour oral glucose tolerance test level of ≥9 mmol/L were individually randomized to either the intervention group receiving the Pregnant+ app and usual care or the control group receiving usual care only. Eligible women were enrolled from 5 diabetes outpatient clinics in the Oslo region, Norway, between October 2015 and April 2017. The Pregnant+ app promoted 10 GDM-specific dietary recommendations. A healthy dietary score for Pregnant+ (HDS-P+) was constructed from a 41-item food frequency questionnaire and used to assess the intervention effect on the dietary behavior completed at trial entry and at around gestation week 36. Dietary changes from baseline to week 36 were examined by a paired sample two-tailed t test. Between-group dietary differences after the intervention were estimated with analysis of covariance, with adjustment for baseline diet. RESULTS A total of 238 women participated: 115 were allocated to the intervention group and 123 to the control group. Of the 238 women, 193 (81.1%) completed the food frequency questionnaire both at baseline and around gestational week 36. All the participants showed improvements in their HDS-P+ from baseline. However, the Pregnant+ app did not have a significant effect on their HDS-P+. The control group reported a higher weekly frequency of choosing fish meals (P=.05). No other significant differences were found between the intervention and control groups. There were no significant demographic baseline differences between the groups, except that more women in the intervention group had a non-Norwegian language as their first language (61 vs 46; P=.02). CONCLUSIONS Our findings do not support the supplementation of face-to-face follow-up of women with GDM with a smartphone app in the presence of high-standard usual care, as the Pregnant+ app did not have a beneficial effect on pregnant women’s diet. CLINICALTRIAL ClinicalTrials.gov NCT02588729; https://clinicaltrials.gov/ct2/show/NCT02588729

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Web-based Therapy Plus Support by a Coach in Depressed Patients Referred to Secondary Mental Health Care: Randomized Controlled Trial

JMIR Mental Health ◽

10.2196/mental.8510 ◽

2018 ◽

Vol 5 (1) ◽

pp. e5 ◽

Cited By ~ 5

Author(s):

Simon Hatcher ◽

Robyn Whittaker ◽

Murray Patton ◽

Wayne Sylvester Miles ◽

Nicola Ralph ◽

...

Keyword(s):

Mental Health ◽

Randomized Controlled Trial ◽

Usual Care ◽

Controlled Trial ◽

Qualitative Interviews ◽

Intervention Group ◽

Control Group ◽

Web Based ◽

Randomized Controlled

Background The evidence for the effectiveness of Web-based therapies comes mainly from nonclinical populations, with a few studies in primary care. There is little evidence from patients referred to secondary mental health care with depression. Adherence to Web-based therapies is often poor. One way to increase this is to create a new health service role of a coach to guide people through the therapy. Objective This study aimed to test in people referred to secondary care with depression if a Web-based therapy (The Journal) supported by a coach plus usual care would be more effective in reducing depression compared with usual care plus an information leaflet about Web-based resources after 12 weeks. Methods We conducted a randomized controlled trial with two parallel arms and a process evaluation that included structured qualitative interviews analyzed using thematic analysis. The coach had a background in occupational therapy. Participants were recruited face-to-face at community mental health centers. Results We recruited 63 people into the trial (intervention 35, control 28). There were no statistically significant differences in the change from baseline in Patient Health Questionnaire-9 (PHQ-9) scores at 12 weeks comparing The Journal with usual care (mean change in PHQ-9 score 9.4 in the intervention group and 7.1 in the control group, t41=1.05, P=.30; mean difference=2.3, 95% CI −2.1 to 6.7). People who were offered The Journal attended on average about one less outpatient appointment compared with usual care, although this difference was not statistically significant (intervention mean number of visits 2.8 (SD 5.5) compared with 4.1 (SD 6.7) in the control group, t45=−0.80, P=.43; mean difference=1.3, 95% CI −4.5 to 2.0). The process evaluation found that the mean number of lessons completed in the intervention group was 2.5 (SD=1.9; range=0-6) and the number of contacts with the coach was a mean of 8.1 (SD=4.4; range=0-17). The qualitative interviews highlighted the problem of engaging clinicians in research and their resistance to recruitment: technical difficulties with The Journal, which prevented people logging in easily; difficulty accessing The Journal as it was not available on mobile devices; participants finding some lessons difficult; and participants saying they were too busy to complete the sessions. Conclusions The study demonstrated that it is feasible to use a coach in this setting, that people found it helpful, and that it did not conflict with other care that participants were receiving. Future trials need to engage clinicians at an early stage to articulate where Web-based therapies fit into existing clinical pathways; Web-based therapies should be available on mobile devices, and logging in should be easy. The role of the coach should be explored in larger trials. Trial Registration Australian New Zealand Clinical Trials Registry (ACTRN): 12613000015741; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=363351&isReview=true (Archived by WebCite at http://www.webcitation.org/6wEyCc6Ss).

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Improving gait adaptability in patients with hereditary spastic paraplegia (Move-HSP): study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-020-04932-9 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Lotte van de Venis ◽

Bart P. C. van de Warrenburg ◽

Vivian Weerdesteyn ◽

Bas J. H. van Lith ◽

Alexander C. H. Geurts ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Usual Care ◽

Hereditary Spastic Paraplegia ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Spastic Paraplegia ◽

Randomized Controlled ◽

Near Falls

Abstract Background People with hereditary spastic paraplegia (HSP) experience difficulties adapting their gait to meet environmental demands, a skill required for safe and independent ambulation. Gait adaptability training is possible on the C-Mill, a treadmill equipped with augmented reality, enabling visual projections to serve as stepping targets or obstacles. It is unknown whether gait adaptability can be trained in people with HSP. Aim The aim of Move-HSP is to study the effects of ten 1-h sessions of C-Mill training, compared with usual care, on gait adaptability in people with pure HSP. In addition, this study aims to identify key determinants of C-Mill training efficacy in people with pure HSP. Method Move-HSP is a 5-week, two-armed, open-label randomized controlled trial with a cross-over design for the control group. Thirty-six participants with pure HSP will be included. After signing informed consent, participants are randomized (1:1) to intervention or control group. All participants register (near) falls for 15 weeks, followed by the first assessment (week 16), and, thereafter, wear an Activ8 activity monitor for 7 days (week 16). The intervention group receives 10 sessions of C-Mill training (twice per week, 1-h sessions; weeks 17–21), whereas control group continues with usual care (weeks 17–21). Afterwards, both groups are re-assessed (week 22). Subsequently, the intervention group enter follow-up, whereas control group receives 10 sessions of C-Mill training (weeks 23–27), is re-assessed (week 28), and enters follow-up. During follow-up, both groups wear Activ8 activity monitors for 7 days (intervention group: week 23, control group: week 29) and register (near) falls for 15 weeks (intervention group: weeks 23–37, control group: weeks 29–43), before the final assessment (intervention group: week 38, control group: week 44). The primary outcome is the obstacle subtask of the Emory Functional Ambulation Profile. Secondary outcomes consist of clinical tests assessing balance and walking capacity, physical activity, and fall monitoring. Discussion Move-HSP will be the first RCT to assess the effects of C-Mill gait adaptability training in people with pure HSP. It will provide proof of concept for the efficacy of gait adaptability training in people with pure HSP. Trial registration Clinicaltrials.gov NCT04180098. Registered on November 27, 2019.

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