Sit-to-stand Training in Stroke Patient

Study Overview
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Brief Summary
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Background: It is unknown whether the self-initiated sit-to-stand training with assistive device is effective to regain the independence of sit-to-stand in stroke patients. Objective: To compare the effectiveness of self-initiated sit-to-stand training by assistive device, with manual sit-to-stand training. Design: Parallel randomised controlled and assessor blinded trial between Jan 2015 and May 2018. Randomisation was performed by drawing lots to allocate treatment to patient. Setting: A rehabilitation hospital in Hong Kong Participants: 69 patients in medical wards with unilateral hemiparetic stroke. 52 patients fulfilled the study requirements. Intervention: Ten sessions of intervention with conventional physiotherapy program followed, by self-initiated sit-to-stand training with assistive device, or by manual sit-to-stand training. Main outcome measure: Number of patients regained the independence of sit-to-stand, Sit-to-stand test from the balance master® and Five-repetitions sit-to-stand test. Results: 69 patients (intervention n=36; control n=33) were randomized (mean age 69.8 (SD, 10.6), mean post stroke days 18.6 (SD 16.0)) for intention to treat analysis. 17 patients were excluded because of dropout before 10 sessions of training, leaving 52 (n=26; n=26) patients for per protocol analysis. 18 patients in intervention group and 10 patients in control group had regained the independence of sit-to-stand (Phil and Cramer's V: -0.31 and 0.31). The patients in intervention group were faster to complete the Five-repetition sit-to-stand test than the control group (32.7 secs (SD, 1.93) v 48.4 secs (SD, 6.8); 95% confidence interval, -30.8 to -0.7; p<0.05). No adverse side effects occurred during and after the training across groups. Conclusions: Self-initiated sit-to-stand training by assistive device can help more stroke patients regain the independence of sit-to-stand.

Official Title
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Does Self-initiated Sit-to-stand Training With Assistive Device Regain the Independence of Sit-to-stand in Stroke Patient? A Single-blinded Randomised Controlled Trial.

Conditions
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Stroke

Intervention / Treatment
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* Device: Mechanical assisted sit-to-stand training group
* Other: Manual assisted sit-to-stand training group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: first episode of unilateral stroke with hemiparesis, able to understand and follow simple verbal instructions, able to sit unsupported for at least two minutes require lifting assistance to stand up from a 18 inches high plinth Exclusion Criteria: severe pain in the lower extremities when weight bearing or performing movement any other acute comorbid diseases such as unstable angina, recent myocardial infarction unstable medical / psychological condition
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>The sit-to-stand training is assisted by mechanical device | Device: Mechanical assisted sit-to-stand training group<br>* Mechanical assisted sit-to-stand training 100 repetitions or 10 mins / session 10 sessions<br>* Other names: sit-to-stand trainer;|
| Active Comparator: Control group<br>The sit-to-stand training is assisted by manual device | Other: Manual assisted sit-to-stand training group<br>* Manual assisted sit-to-stand training 100 repetitions or 10 mins / session 10 sessions<br>* Other names: physiotherapist assisted;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients regained the independence of sit-to-stand | To compare how many patients can regain the independence of sit-to-stand between groups | After 10 sessions of training | 
| Sit-to-Stand Test (SST) from the Balance Master® | To assess the quality of sit-to-stand of patient | After 10 sessions of training | 
| Five-Repetition Sit-to-Stand Test | To assess the functional strength of lower limb, balance and transition move of patient | After 10 sessions of training |