Effects of training with a passive hand orthosis and games at home in chronic stroke: a pilot randomised controlled trial

Objectives: To compare user acceptance and arm and hand function changes after technology-supported training at home with conventional exercises in chronic stroke. Secondly, to investigate the relation between training duration and clinical changes. Design: A randomised controlled trial. Setting: Training at home, evaluation at research institute. Subjects: Twenty chronic stroke patients with severely to mildly impaired arm and hand function. Interventions: Participants were randomly assigned to six weeks (30 minutes per day, six days a week) of self-administered home-based arm and hand training using either a passive dynamic wrist and hand orthosis combined with computerised gaming exercises (experimental group) or prescribed conventional exercises from an exercise book (control group). Main measures: Main outcome measures are the training duration for user acceptance and the Action Research Arm Test for arm and hand function. Secondary outcomes are the Intrinsic Motivation Inventory, Fugl-Meyer assessment, Motor Activity Log, Stroke Impact Scale and grip strength. Results: The control group reported a higher training duration (189 versus 118 minutes per week, P = 0.025). Perceived motivation was positive and equal between groups ( P = 0.935). No differences in clinical outcomes over training between groups were found (P ⩾ 0.165). Changes in Box and Block Test correlated positively with training duration ( P = 0.001). Conclusions: Both interventions were accepted. An additional benefit of technology-supported arm and hand training over conventional arm and hand exercises at home was not demonstrated. Training duration in itself is a major contributor to arm and hand function improvements.

Download Full-text

Supported progressive resistance exercise training to counter the adverse side effects of robot-assisted radical prostatectomy: a randomised controlled trial

Supportive Care in Cancer ◽

10.1007/s00520-021-06002-5 ◽

2021 ◽

Author(s):

Ruth E. Ashton ◽

Jonathan J. Aning ◽

Garry A. Tew ◽

Wendy A Robson ◽

John M Saxton

Keyword(s):

Randomised Controlled Trial ◽

Radical Prostatectomy ◽

Muscular Strength ◽

Controlled Trial ◽

Control Group ◽

Robot Assisted ◽

Resistance Exercise Training ◽

Home Based ◽

Aerobic Exercise Capacity ◽

Randomised Controlled

Abstract Purpose To investigate the effects of a supported home-based progressive resistance exercise training (RET) programme on indices of cardiovascular health, muscular strength and health-related quality of life (HR-QoL) in prostate cancer (PCa) patients after treatment with robot-assisted radical prostatectomy (RARP). Methods This study was a single-site, two-arm randomised controlled trial, with 40 participants randomised to either the intervention or control group over a 10-month period. In addition to receiving usual care, the intervention group completed three weekly RET sessions using resistance bands for 6 months. Participants performed 3 sets of 12–15 repetitions for each exercise, targeting each major muscle group. The control group received usual care only. Brachial artery flow-mediated dilatation (FMD) was the primary outcome and assessed at baseline, 3 and 6 months. Secondary outcomes included body weight, body fat, aerobic fitness, strength and blood-borne biomarkers associated with cardiometabolic risk. Results There was no significant difference between the groups in FMD at 3 or 6 months. However, there were improvements in aerobic exercise capacity (P < 0.01) and upper- (P < 0.01) and lower-limb (P = 0.01) strength in favour of the RET group at 6 months, accompanied by greater weight loss (P = 0.04) and a reduction in body fat (P = 0.02). Improvements in HRQoL were evident in the RET group at 3 and 6 months via the PCa-specific component of the FACT-P questionnaire (both P < 0.01). Five adverse events and one serious adverse event were reported throughout the trial duration. Conclusion This study demonstrates that home-based RET is an effective and safe mode of exercise that elicits beneficial effects on aerobic exercise capacity, muscular strength and HR-QoL in men who have undergone RARP. Trial registration ISRCTN10490647.

Download Full-text

From randomised controlled trial to real world implementation of a novel home-based heart failure tool: pooled and comparative analyses of two clinical controlled trials

Open Heart ◽

10.1136/openhrt-2018-000954 ◽

2019 ◽

Vol 6 (1) ◽

pp. e000954 ◽

Cited By ~ 1

Author(s):

Ann Hovland-Tånneryd ◽

Michael Melin ◽

Ewa Hägglund ◽

Inger Hagerman ◽

Hans E Persson

Keyword(s):

Heart Failure ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Self Care ◽

Control Group ◽

Data Set ◽

Pooled Data ◽

Home Based ◽

Randomised Controlled ◽

Hospital Days

ObjectivesA home-based tool for heart failure (HF) patients, was evaluated in a specialist setting as a randomised controlled trial (RCT) and also in a validation cohort in a primary care setting in a clinical controlled trial (CCT). The tool provides education, symptom monitoring and titration of diuretics. The aim of this study was thus to extend validity of the previous RCT findings in order to describe applicability of the tool in clinical practice.MethodsData from both trials were analysed separately, as well as a pooled data set (n=172). Data were analysed with respect to HF related in-hospital days, self-care behaviour and system adherence, during a 6-month intervention. The analysis of in-hospital days for the pooled data was adjusted for baseline differences between the two study cohorts, relating to disease state.ResultsIn the RCT (n=72) the intervention group (IG) consisted of 32 patients and the control group (CG) of 40 patients. The risk ratio (RR) for in-hospital days was RR: 0.72, 95% CI 0.61 to 0.84, p<0.05 in favour of the IG. In the CCT (n=100) both the IG and the CG consisted of 50 patients and the IG had fewer in-hospitals days, comparable to the RCT findings with RR: 0.67; 95% CI 0.45 to 0.99; p<0.05. For the pooled data set made up of 172 patients, the groups were well balanced but with a higher prevalence of hypertension in the CG. The RR relating to in-hospital days for the pooled data set was 0.71; 95% CI 0.61 to 0.82; p<0.05 in favour of the IG. There was a statistically significant improvement in self-care by 27% and the median system adherence was 94%.ConclusionsThese analyses suggest that the evaluated tool might reduce HF related in-hospital days in the general HF population, which adds to the external validity of previous findings.Clinical Trial RegistrationNCT03655496.

Download Full-text

Enriched Music-supported Therapy for chronic stroke patients: a study protocol of a randomised controlled trial

BMC Neurology ◽

10.1186/s12883-020-02019-1 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Jennifer Grau-Sánchez ◽

Emma Segura ◽

David Sanchez-Pinsach ◽

Preeti Raghavan ◽

Thomas F. Münte ◽

...

Keyword(s):

Quality Of Life ◽

Randomised Controlled Trial ◽

Upper Limb ◽

Controlled Trial ◽

Well Being ◽

Chronic Stroke ◽

Stroke Patients ◽

Home Based ◽

Randomised Controlled

Abstract Background Residual motor deficits of the upper limb in patients with chronic stroke are common and have a negative impact on autonomy, participation and quality of life. Music-Supported Therapy (MST) is an effective intervention to enhance motor and cognitive function, emotional well-being and quality of life in chronic stroke patients. We have adapted the original MST training protocol to a home-based intervention, which incorporates increased training intensity and variability, group sessions, and optimisation of learning to promote autonomy and motivation. Methods A randomised controlled trial will be conducted to test the effectiveness of this enriched MST (eMST) protocol in improving motor functions, cognition, emotional well-being and quality of life of chronic stroke patients when compared to a program of home-based exercises utilizing the Graded Repetitive Arm Supplementary Program (GRASP). Sixty stroke patients will be recruited and randomly allocated to an eMST group (n = 30) or a control GRASP intervention group (n = 30). Patients will be evaluated before and after a 10-week intervention, as well as at 3-month follow-up. The primary outcome of the study is the functionality of the paretic upper limb measured with the Action Research Arm Test. Secondary outcomes include other motor and cognitive functions, emotional well-being and quality of life measures as well as self-regulation and self-efficacy outcomes. Discussion We hypothesize that patients treated with eMST will show larger improvements in their motor and cognitive functions, emotional well-being and quality of life than patients treated with a home-based GRASP intervention. Trial registration The trial has been registered at ClinicalTrials.gov and identified as NCT04507542 on 8 August 2020.

Download Full-text

Robotic-based ACTive somatoSENSory (Act.Sens) retraining on upper limb functions with chronic stroke survivors: study protocol for a pilot randomised controlled trial

Pilot and Feasibility Studies ◽

10.1186/s40814-021-00948-3 ◽

2021 ◽

Vol 7 (1) ◽

Author(s):

Ananda Sidarta ◽

Yu Chin Lim ◽

Christopher Wee Keong Kuah ◽

Yong Joo Loh ◽

Wei Tech Ang

Keyword(s):

Randomised Controlled Trial ◽

Study Protocol ◽

Upper Limb ◽

Controlled Trial ◽

Chronic Stroke ◽

Community Dwelling ◽

Control Group ◽

Stroke Survivors ◽

Pilot Randomised Controlled Trial ◽

Randomised Controlled

Abstract Background Prior studies have established that senses of the limb position in space (proprioception and kinaesthesia) are important for motor control and learning. Although nearly one-half of stroke patients have impairment in the ability to sense their movements, somatosensory retraining focusing on proprioception and kinaesthesia is often overlooked. Interventions that simultaneously target motor and somatosensory components are thought to be useful for relearning somatosensory functions while increasing mobility of the affected limb. For over a decade, robotic technology has been incorporated in stroke rehabilitation for more controlled therapy intensity, duration, and frequency. This pilot randomised controlled trial introduces a compact robotic-based upper-limb reaching task that retrains proprioception and kinaesthesia concurrently. Methods Thirty first-ever chronic stroke survivors (> 6-month post-stroke) will be randomly assigned to either a treatment or a control group. Over a 5-week period, the treatment group will receive 15 training sessions for about an hour per session. Robot-generated haptic guidance will be provided along the movement path as somatosensory cues while moving. Audio-visual feedback will appear following every successful movement as a reward. For the same duration, the control group will complete similar robotic training but without the vision occluded and robot-generated cues. Baseline, post-day 1, and post-day 30 assessments will be performed, where the last two sessions will be conducted after the last training session. Robotic-based performance indices and clinical assessments of upper limb functions after stroke will be used to acquire primary and secondary outcome measures respectively. This work will provide insights into the feasibility of such robot-assisted training clinically. Discussion The current work presents a study protocol to retrain upper-limb somatosensory and motor functions using robot-based rehabilitation for community-dwelling stroke survivors. The training promotes active use of the affected arm while at the same time enhances somatosensory input through augmented feedback. The outcomes of this study will provide preliminary data and help inform the clinicians on the feasibility and practicality of the proposed exercise. Trial registration ClinicalTrials.gov NCT04490655. Registered 29 July 2020.

Download Full-text

Home-based pulmonary rehabilitation early after hospitalisation in COPD (early HomeBase): protocol for a randomised controlled trial

BMJ Open Respiratory Research ◽

10.1136/bmjresp-2021-001107 ◽

2021 ◽

Vol 8 (1) ◽

pp. e001107

Author(s):

Narelle S Cox ◽

Aroub Lahham ◽

Christine F McDonald ◽

Ajay Mahal ◽

Paul O'Halloran ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Usual Care ◽

Hospital Discharge ◽

Hospital Readmission ◽

Pulmonary Rehabilitation ◽

Controlled Trial ◽

Control Group ◽

Home Based ◽

Randomised Controlled

IntroductionChronic obstructive pulmonary disease (COPD) is characterised by exacerbations of respiratory disease, frequently requiring hospital admission. Pulmonary rehabilitation can reduce the likelihood of future hospitalisation, but programme uptake is poor. This study aims to compare hospital readmission rates, clinical outcomes and costs between people with COPD who undertake a home-based programme of pulmonary rehabilitation commenced early (within 2 weeks) of hospital discharge with usual care.MethodsA multisite randomised controlled trial, powered for superiority, will be conducted in Australia. Eligible patients admitted to one of the participating sites for an exacerbation of COPD will be invited to participate. Participants will be randomised 1:1. Intervention group participants will undertake an 8-week programme of home-based pulmonary rehabilitation commencing within 2 weeks of hospital discharge. Control group participants will receive usual care and a weekly phone call for attention control. Outcomes will be measured by a blinded assessor at baseline, after the intervention (week 9–10 posthospital discharge), and at 12 months follow-up. The primary outcome is hospital readmission at 12 months follow-up.Ethics and disseminationHuman Research Ethics approval for all sites provided by Alfred Health (Project 51216). Findings will be published in peer-reviewed journals, conferences and lay publications.Trial registration numberACTRN12619001122145.

Download Full-text

Lifestyle integrated functional exercise for people with dementia: study protocol for a home-based randomised controlled trial

International Journal of Therapy and Rehabilitation ◽

10.12968/ijtr.2019.0066 ◽

2020 ◽

Vol 27 (5) ◽

pp. 1-14

Author(s):

Sara Almeida ◽

Madalena Gomes da Silva ◽

Alda Marques

Keyword(s):

Physical Activity ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Primary Outcome Measure ◽

Step Test ◽

Control Group ◽

People With Dementia ◽

Home Based ◽

Functional Exercise ◽

Randomised Controlled

Background/Aims Physical activity is effective in people with dementia. Most people with dementia live at home, but few home-based physical activity programmes have been developed. The aim of this protocol is to determine the feasibility, effectiveness and cost-effectiveness of the Lifestyle Integrated Functional Exercise for People with Dementia (LiFE4D). Methods A randomised, controlled trial will be implemented. The experimental group will receive LiFE4D and the control group will maintain usual treatment. LiFE4D is a 3-month programme adjusted to daily routines and involving carers, with decreased face-to-face contact over time. The primary outcome measure is exercise capacity assessed with the 2-Minute Step Test. Secondary outcomes include cognitive function, physical activity, health-related physical fitness, respiratory function, functionality, quality of life, carers' burden and costs. Results Findings from this study will improve knowledge and provide guidance on home-based physical activity for people with dementia. Conclusions If effective, the trial will provide a model of home-based physical activity and inform international guidelines for dementia care.

Download Full-text

Does perturbation-based balance training prevent falls among individuals with chronic stroke? A randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2018-021510 ◽

2018 ◽

Vol 8 (8) ◽

pp. e021510 ◽

Cited By ~ 28

Author(s):

Avril Mansfield ◽

Anthony Aqui ◽

Cynthia J Danells ◽

Svetlana Knorr ◽

Andrew Centen ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Rate Ratio ◽

Daily Life ◽

Controlled Trial ◽

Balance Training ◽

Chronic Stroke ◽

Secondary Outcome ◽

Control Group ◽

Randomised Controlled ◽

And Control

ObjectivesNo intervention has been shown to prevent falls poststroke. We aimed to determine if perturbation-based balance training (PBT) can reduce falls in daily life among individuals with chronic stroke.DesignAssessor-blinded randomised controlled trial.SettingTwo academic hospitals in an urban area.InterventionsParticipants were allocated using stratified blocked randomisation to either ‘traditional’ balance training (control) or PBT. PBT focused on improving responses to instability, whereas traditional balance training focused on maintaining stability during functional tasks. Training sessions were 1 hour twice/week for 6 weeks. Participants were also invited to complete 2 ‘booster’ training sessions during the follow-up.ParticipantsEighty-eight participants with chronic stroke (>6 months poststroke) were recruited and randomly allocated one of the two interventions. Five participants withdrew; 42 (control) and 41 (PBT group) were included in the analysis.Primary and secondary outcome measuresThe primary outcome was rate of falls in the 12 months post-training. Negative binomial regression was used to compare fall rates between groups. Secondary outcomes were measures of balance, mobility, balance confidence, physical activity and social integration.ResultsPBT participants reported 53 falls (1.45 falls/person-year) and control participants reported 64 falls (1.72 falls/person-year; rate ratio: 0.85(0.42 to 1.69); p=0.63). Per-protocol analysis included 32 PBT and 34 control participants who completed at least 10/12 initial training sessions and 1 booster session. Within this subset, PBT participants reported 32 falls (1.07 falls/person-year) and control participants reported 57 falls (1.75 falls/person-year; rate ratio: 0.62(0.29 to 1.30); p=0.20). PBT participants had greater improvement in reactive balance control than the control group, and these improvements were sustained 12 months post-training. There were no intervention-related serious adverse effects.ConclusionsThe results are inconclusive. PBT may help to prevent falls in daily life poststroke, but ongoing training may be required to maintain the benefits.Trial registration numberISRCTN05434601; Results.

Download Full-text

Effectiveness of home or hospital initiation of treatment at diagnosis for children with type 1 diabetes (DECIDE trial): a multicentre individually randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2019-032317 ◽

2019 ◽

Vol 9 (12) ◽

pp. e032317 ◽

Cited By ~ 2

Author(s):

John W Gregory ◽

Julia Townson ◽

Sue Channon ◽

David Cohen ◽

Mirella Longo ◽

...

Keyword(s):

Type 1 Diabetes ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Newly Diagnosed ◽

Home Based ◽

Secondary Outcomes ◽

Randomised Controlled ◽

At Home

ObjectiveTo determine whether, in children with newly diagnosed type 1 diabetes who were not acutely unwell, management at home for initiation of insulin treatment and education of the child and family, would result in improved clinical and psychological outcomes at 2 years postdiagnosis.DesignA multicentre randomised controlled trial (January 2008/October 2013).SettingEight paediatric diabetes centres in England, Wales and Northern Ireland.Participants203 clinically well children aged under 17 years, with newly diagnosed type 1 diabetes and their carers.InterventionManagement of the initiation period from diagnosis at home, for a minimum of 3 days, to include at least six supervised injections and delivery of pragmatic educational care.Main outcome measuresPrimary outcome was glycosylated haemoglobin (HbA1c) concentration at 24 months postdiagnosis. Secondary outcomes included coping, anxiety, quality of life and use of NHS resources.Results203 children, newly diagnosed, were randomised to commence management at home (n=101) or in hospital (n=102). At the 24 month primary end point, there was one withdrawal and a follow-up rate of 194/202 (96%). Mean HbA1c in the home treatment arm was 72.1 mmol/mol and in the hospital treated arm 72.6 mmol/mol. There was a negligible difference between the mean HbA1c levels in the two arms adjusted for baseline (1.01, 95% CI 0.93 to 1.09). There were mostly no differences in secondary outcomes at 24 months, apart from better child self-esteem in the home-arm. No home-arm children were admitted to hospital during initiation and there were no adverse events at that time. The number of investigations was higher in hospital patients during the follow-up period. There were no differences in insulin regimens between the two arms.ConclusionsThere is no evidence of a difference between home-based and hospital-based initiation of care in children newly diagnosed with type 1 diabetes across relevant outcomes.Trial registration numberISRCTN78114042.

Download Full-text

Feasibility, acceptability, and potential efficacy of an innovative postnatal home-based breastfeeding peer support programme in Hong Kong: a feasibility and pilot randomised controlled trial

International Breastfeeding Journal ◽

10.1186/s13006-021-00381-5 ◽

2021 ◽

Vol 16 (1) ◽

Author(s):

Kris Yuet-Wan Lok ◽

Charlotte L. Y. Chow ◽

Jeffery Sheung Yu Shing ◽

Robert Smith ◽

Christine Chi Oi Lam ◽

...

Keyword(s):

Hong Kong ◽

Randomised Controlled Trial ◽

Peer Support ◽

Exclusive Breastfeeding ◽

Controlled Trial ◽

Control Group ◽

Support Programme ◽

Home Based ◽

Randomised Controlled

Abstract Background As suggested by the World Health Organization, breastfeeding peer support is being introduced worldwide to support women’s breastfeeding needs. Evidence has shown that when such support is offered to women, the duration and exclusivity of breastfeeding is increased. We developed an innovative home-based intervention to sustain exclusive breastfeeding in Hong Kong. However, potential barriers must be addressed before a full randomised controlled trial (RCT) is conducted. The aim of this study was to determine the feasibility of a breastfeeding support programme with home-based visits from peer supporters over a six month period among postpartum Chinese women in Hong Kong. Methods We conducted a feasibility and pilot randomised controlled trial. Twenty primiparous women intending to breastfeed their healthy term singleton infant were recruited from a hospital in Kowloon, Hong Kong between February and March 2019. Participants were randomly allocated to the intervention or control group. Participants in the intervention group received five home-based visits with a peer supporter over a six month period, as well as standard care, whereas participants in the control group received standard care only. We assessed feasibility, compliance, and acceptability of the breastfeeding peer support programme. Other outcomes assessed were breastfeeding self-efficacy, duration, and exclusivity. Results It was feasible to recruit and train existing peer supporters, and peer supporters were able to deliver the intervention, which was acceptable to women, but rates of stopping the intervention and loss to follow-up were high. There was higher retention seen within the first month. Women interviewed at the end of the study reported that the intervention was positive. The cessation risk of any, and exclusive breastfeeding were not statistically different between the intervention and control groups. Conclusions This study provided valuable information on feasibility of the trial design and intervention. Modifications to the intervention, such as targeting women with lower breastfeeding self-efficacy, or combining home visits with technology and telephone follow-up may be more appropriate in a larger trial. Implementing the programme early during the antenatal phase and tailoring peer support to most appropriately sustain exclusive breastfeeding and other feeding modes should be incorporated in a future home-based peer support arm. Trial registration NCT03705494 on 15 Oct 2018.

Download Full-text

Nurse-based secondary preventive follow-up by telephone reduced recurrence of cardiovascular events: a randomised controlled trial

Scientific Reports ◽

10.1038/s41598-021-94892-0 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Anna-Lotta Irewall ◽

Anders Ulvenstam ◽

Anna Graipe ◽

Joachim Ögren ◽

Thomas Mooe

Keyword(s):

Randomised Controlled Trial ◽

Primary Endpoint ◽

Cardiovascular Events ◽

Controlled Trial ◽

Control Group ◽

Coronary Syndrome ◽

Secondary Endpoints ◽

Randomised Controlled

AbstractEnhanced follow-up is needed to improve the results of secondary preventive care in patients with established cardiovascular disease. We examined the effect of long-term, nurse-based, secondary preventive follow-up by telephone on the recurrence of cardiovascular events. Open, randomised, controlled trial with two parallel groups. Between 1 January 2010 and 31 December 2014, consecutive patients (n = 1890) admitted to hospital due to stroke, transient ischaemic attack (TIA), or acute coronary syndrome (ACS) were included. Participants were randomised (1:1) to nurse-based telephone follow-up (intervention, n = 944) or usual care (control, n = 946) and followed until 31 December 2017. The primary endpoint was a composite of stroke, myocardial infarction, cardiac revascularisation, and cardiovascular death. The individual components of the primary endpoint, TIA, and all-cause mortality were analysed as secondary endpoints. The assessment of outcome events was blinded to study group assignment. After a mean follow-up of 4.5 years, 22.7% (n = 214) of patients in the intervention group and 27.1% (n = 256) in the control group reached the primary composite endpoint (HR 0.81, 95% CI 0.68–0.97; ARR 4.4%, 95% CI 0.5–8.3). Secondary endpoints did not differ significantly between groups. Nurse-based secondary preventive follow-up by telephone reduced the recurrence of cardiovascular events during long-term follow-up.

Download Full-text