scholarly journals Can a pathological model improve the abilities of the paretic hand in hemiplegic children? The PAM-AOT study protocol of a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e053910
Author(s):  
Jessica Verzelloni ◽  
Antonino Errante ◽  
Laura Beccani ◽  
Mariacristina Filippi ◽  
Barbara Bressi ◽  
...  
Keyword(s):  
Upper Limb ◽  
Mirror Neuron System ◽  
Action Observation ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Limb Function ◽  
Upper Limb Function ◽  
Pathological Model ◽  
Randomised Controlled

IntroductionAction Observation Treatment (AOT) is an innovative therapeutic approach consisting in the observation of actions followed by subsequent repetition. In children with unilateral cerebral palsy (UCP), it improves upper limb function in daily activities. The standard paradigm of AOT requires the observation of healthy models; however, it has been demonstrated that the mirror neuron system of children with UCP is more activated by observation of pathological models, showing a similar motor repertoire, than by the healthy model, suggesting that AOT based on pathological models is superior to the standard paradigm of AOT in the functional rehabilitation of the affected upper limb of children with UCP.Methods and analysisThis protocol describes an active two-arm randomised controlled evaluator-blinded trial. Twenty-six children with UCP will participate in 3 weeks of intensive AOT: the experimental group will observe a pathological model, while the control group will observe a typically developed model. The primary outcome is the spontaneous use of the paretic hand, measured with the Assisting Hand Assessment. Secondary outcome measures are the Melbourne Assessment of Unilateral Upper Limb Function, the ABILHAND-Kids and the Activities Scale for Kids-performance. Assessments will be performed at baseline (T0), at the end of intensive AOT (T1), at 8–12 weeks (T2) and at 24–28 weeks (T3) after the end of intensive AOT.Ethics and disseminationThe trial was approved by the Area Vasta Emilia Nord Ethics Committee (AVEN prot. n. 133117, 29 November 2018), and it was prospectively registered on ClinicalTrials.gov. The results will be submitted for publication to a peer-reviewed journal, discussed with parents of children participating in the trial and disseminated at suitable conferences.Trial registration numberNCT04088994; Pre-results.

scholarly journals SaeboGlove therapy for upper limb disability and severe hand impairment after stroke (SUSHI): Study protocol for a randomised controlled trial

2021 ◽  
pp. 239698732110365
Author(s):  
Jen Alexander ◽  
Peter Langhorne ◽  
Lisa Kidd ◽  
Olivia Wu ◽  
Alex McConnachie ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Upper Limb ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Economic Evaluations ◽  
Limb Function ◽  
Upper Limb Function ◽  
Randomised Controlled ◽  
Hand Impairment

Background Impaired active digital extension is common after stroke, hindering functional rehabilitation, and predicting poor recovery. The SaeboGlove assists digital extension and may improve outcome after stroke. We recently performed a single group, open, pilot trial of the SaeboGlove early after stroke which demonstrated satisfactory safety, feasibility and acceptability. An adequately powered randomised clinical trial is now needed to assess the clinical effectiveness of the SaeboGlove. Methods SUSHI is a pragmatic, multicentre, parallel-group, randomised controlled trial with blinded outcome assessment, and embedded process and economic evaluations. Adults, 7–60 days post-stroke, with upper limb disability and severe hand impairment, including reduced active digital extension, will be recruited from NHS inpatient stroke services in Scotland. Participants will be randomised on a 1:1 basis to receive 6 weeks of self-directed, repetitive, functional-based practice involving a SaeboGlove plus usual care, or usual care only. The primary outcome is upper limb function measured by the Action Research Arm Test (ARAT) at 6 weeks. Secondary outcomes will be measured at 6 and 14 weeks. A process evaluation will be performed via interviews with ‘intervention’ participants, and their carers and clinical therapists. A within-trial cost-effectiveness analysis will be performed. 110 participants are required to detect a difference between groups of 9 in the ARAT with 90% power at a 5% significance level allowing for 11% attrition. Discussion SUSHI will determine if SaeboGlove self-directed, repetitive, functional-based practice improves upper limb function after stroke, whether it is acceptable to stroke survivors and whether it is cost-effective.

scholarly journals Effectiveness of ultrasound guided ethanol motor points block in reduction of spasticity and improvement of upper limb function in hemiplegic patients: a randomized controlled study

2020 ◽  
Vol 7 (9) ◽  
pp. 1409
Author(s):  
Sreejith C. ◽  
Akoijam Joy Singh ◽  
Longjam Nilachandra Singh ◽  
Kanti Rajkumari ◽  
Margaret Chabungbam ◽  
...  
Keyword(s):  
Upper Limb ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Control Group ◽  
Ultrasound Guided ◽  
Limb Function ◽  
Ethanol Injection ◽  
Randomized Controlled ◽  
Upper Limb Function ◽  
Group A

Background: Stroke is the third leading cause of disability in general population commonly causing upper motor neuron syndrome complications like spasticity, which is more common in upper limb. Ethanol injection into spastic muscle is an emerging effective treatment in the spasticity management. Ethanol causes selective destruction of nerve fibers through denaturation of protein.Methods: A randomized controlled study was conducted for a period of 2 years from March 2018 on sixty-eight hemiplegic patients to assess the effectiveness of ethanol muscle block in reduction of spasticity and improvement in functional ability. The patients were allocated into two groups (Group A and B). Group A received ultrasound guided intramuscular ethanol injection along with range of motion (ROM) exercises and wrist hand orthosis (WHO) and Group B received ROM exercises and WHO. The outcomes were measured by modified ashworth scale (MAS) for spasticity and modified version of motor assessment scale for functional improvement.Results: Intervention group showed significant improvement in spasticity shown by reduction of MAS of elbow flexors from 3 at baseline to 1.15±0.3 at 12 weeks as compared to control group with 3 at baseline to 1.76±0.5 at 12 weeks (p<0.05). Upper limb function scale of study group improved from 1.5±0.8 to 3.0±0.6 at 12 weeks compared to control group 1.3±0.8 to 2.8±0.6 (p<0.05).Conclusions: It can thus be concluded that intramuscular injection of ethanol accompanied by wrist hand orthosis have beneficial effect on improvement of spasticity and upper limb function.

scholarly journals Effect of Self-care Training on Upper Limb Function and Pain After Breast Cancer Surgery

2021 ◽  
Vol 10 (2) ◽  
Author(s):  
Somyye Noura ◽  
Fatemeh Kiani ◽  
Nezarali Moulaei ◽  
Mojtaba Tasbandi ◽  
Ebrahim Ebrahimi Tabas
Keyword(s):  
Breast Cancer ◽  
Upper Limb ◽  
Intervention Group ◽  
Self Care ◽  
Control Group ◽  
Limb Function ◽  
Upper Limb Function ◽  
Care Training ◽  
The Mean ◽  
And Control

Background: Breast cancer patients who undergo mastectomy encounter numerous problems, the most annoying of which is lymphedema followed by pain and decreased function in the affected limb. Objectives: This study examined the effect of self-care training on upper limb function and pain after breast surgery. Methods: This quasi-experimental study was performed on two groups of 60 patients with breast cancer in the Oncology Ward of Zahedan University of Medical Sciences in 2021. The patients were selected based on the inclusion criteria and through convenience sampling and were then randomly divided into intervention and control groups. The patients in the intervention group attended self-care training and exercise programs implemented in five sessions in addition to the routine care. One and three months after the intervention, upper limb function and pain were measured with DASH and McGill pain questionnaires. The repeated measures analysis of variance (ANOVA) and Bonferroni test were used to compare the pre-, and post-intervention mean scores and mean differences in the two groups. Results: The mean scores of upper limb function one and three months after the training program in the intervention group were lower than the mean scores of the control group. In other words, the quality of upper limb function was not significantly different despite the changes in the first month, but upper limb function significantly improved three months after the intervention (P < 0.001 vs. P = 0.06). The mean pain scores before, one month, and three months after the intervention in the intervention group were 10.4, 35.7, and 6.26, respectively, and the corresponding values in the control group were 10.8, 41.7, and 21.1, respectively, showing significant differences between the two groups, with the intervention group having lower pain scores than the control group (P = 0.001). Conclusions: Since lymphedema and its consequences, including decreased upper limb function and pain, are very serious issues, medical staff can give priority to this training program and implement it to prevent and control these complications.

Effects of golf training on cognition in older adults: a randomised controlled trial

2018 ◽  
Vol 72 (10) ◽  
pp. 944-950 ◽  
Author(s):  
Hiroyuki Shimada ◽  
Sangyoon Lee ◽  
Masahiro Akishita ◽  
Koichi Kozaki ◽  
Katsuya Iijima ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Training Group ◽  
Community Dwelling ◽  
Secondary Outcome ◽  
Control Group ◽  
Logical Memory ◽  
Randomised Controlled

BackgroundAlthough research indicates that a physically active lifestyle has the potential to prevent cognitive decline and dementia, the optimal type of physical activity/exercise remains unclear. The present study aimed to determine the cognitive benefits of a golf-training programme in community-dwelling older adults.MethodsWe conducted a randomised controlled trial between August 2016 and June 2017 at a general golf course. Participants included 106 Japanese adults aged 65 and older. Participants were randomly assigned to either a 24-week (90–120 min sessions/week) golf-training group or a health education control group. Postintervention changes in Mini-mental State Examination (MMSE) and National Centre for Geriatrics and Gerontology-Functional Assessment Tool scores were regarded as primary outcome measures. Secondary outcome measures included changes in physical performance and Geriatric Depression Scale (GDS) scores.ResultsA total of 100 participants (golf training, n=53; control, n=47) completed the assessments after the 24-week intervention period. The adherence to the golf programme was 96.2% (51/53 participants). Analysis using linear mixed models revealed that the golf training group exhibited significantly greater improvements in immediate logical memory (p=0.033), delayed logical memory (p=0.009) and composite logical memory (p=0.013) scores than the control group. However, no significant changes in MMSE, word memory, Trail Making Test or Symbol Digital Substitution Test scores were observed. In addition, no significant changes in grip strength, walking speed or GDS were observed.ConclusionsGolf-based exercise interventions may improve logical memory in older adults, but no significant changes in other cognitive tests. Further follow-up investigations are required to determine whether the observed effects are associated with delayed onset of mild cognitive impairment or Alzheimer’s disease in older adults.Trial registration numberUMIN-CTR UMIN000024797; Pre-results.

scholarly journals Open-labelled randomised controlled trial of 12 hours versus 24 hours modified Pritchard regimen in the management of eclampsia and pre-eclampsia in Ghana (MOPEP Study): study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e032799 ◽  
Author(s):  
Titus Beyuo ◽  
Emma Lawrence ◽  
Elizabeth S Langen ◽  
Samuel A Oppong
Keyword(s):  
Randomised Controlled Trial ◽  
Health Outcomes ◽  
Magnesium Sulfate ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
University Of Michigan ◽  
Clinical Trial Registry ◽  
Randomised Controlled ◽  
Study Participants

IntroductionHypertensive disorders of pregnancy continue to be a major contributor to maternal and perinatal morbidity and mortality. Magnesium sulfate therapy is the standard of care for seizure prophylaxis and treatment for pre-eclampsia and eclampsia respectively, despite wide disparities in dosing regimens and routes of administration. This study compares the clinical efficacy of magnesium sulfate in the reduction of seizure occurrence or recurrence with the 12 hours versus 24 hours modified Pritchard regimens in the management of severe pre-eclampsia and eclampsia.Methods and analysisThis study is an open labelled randomised controlled trial. The study participants are patients admitted to the Korle Bu Teaching Hospital (KBTH) in Accra, Ghana with a diagnosis of antepartum, intrapartum or postpartum eclampsia or pre-eclampsia with severe features. All study participants will be administered a loading dose of magnesium sulfate, followed by maintenance dosing. Participants in the control group will receive magnesium sulfate for 24 hours after diagnosis, while those in the treatment group will receive magnesium sulfate for 12 hours after diagnosis. The primary outcome of this study is the occurrence of a seizure any time after the completion of treatment in the assigned group. Secondary outcome measures include maternal health outcomes, magnesium sulfate toxicities and fetal health outcomes. Data collection was started in October 2018 with a target enrolment of 1245 participants with severe pre-eclampsia and 844 participants with eclampsia with a projected study period of 2–3 years.Ethics and disseminationEthical approval was obtained from the KBTH Institutional Review Board (IRB) in Ghana. University of Michigan involvement is limited to protocol development and statistical analysis of de-identified data, and has been granted a Not Regulated Determination by the University of Michigan IRB. Results of the study will be shared at clinical forums at the KBTH and will be submitted for publication in an international peer-reviewed journal.Trial registration numberPan African Clinical Trial Registry through the South African Medical Research Council (PACTR201811515303983).

Sign in / Sign up

Export Citation Format

Share Document