Sit-to-stand Training in Stroke Patient
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mechanical assisted sit-to-stand training group
Manual assisted sit-to-stand training group
Sponsored by

About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
Control group
Arm Description
The sit-to-stand training is assisted by mechanical device
The sit-to-stand training is assisted by manual device
Outcomes
Primary Outcome Measures
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
Sit-to-Stand Test (SST) from the Balance Master®
To assess the quality of sit-to-stand of patient
Five-Repetition Sit-to-Stand Test
To assess the functional strength of lower limb, balance and transition move of patient
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03273101
Brief Title
Sit-to-stand Training in Stroke Patient
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
May 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tai Po Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The sit-to-stand training is assisted by mechanical device
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The sit-to-stand training is assisted by manual device
Intervention Type
Device
Intervention Name(s)
Mechanical assisted sit-to-stand training group
Other Intervention Name(s)
sit-to-stand trainer
Intervention Description
Mechanical assisted sit-to-stand training 100 repetitions or 10 mins / session 10 sessions
Intervention Type
Other
Intervention Name(s)
Manual assisted sit-to-stand training group
Other Intervention Name(s)
physiotherapist assisted
Intervention Description
Manual assisted sit-to-stand training 100 repetitions or 10 mins / session 10 sessions
Primary Outcome Measure Information:
Title
Number of patients regained the independence of sit-to-stand
Description
To compare how many patients can regain the independence of sit-to-stand between groups
Time Frame
After 10 sessions of training
Title
Sit-to-Stand Test (SST) from the Balance Master®
Description
To assess the quality of sit-to-stand of patient
Time Frame
After 10 sessions of training
Title
Five-Repetition Sit-to-Stand Test
Description
To assess the functional strength of lower limb, balance and transition move of patient
Time Frame
After 10 sessions of training
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ng Chee Man, Joey, Master
Organizational Affiliation
Tai Po Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Woo Ka Ho, Marc, Master
Organizational Affiliation
Prince of Wales Hospital
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
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Sit-to-stand Training in Stroke Patient
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