Study Results
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Basic Information
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COMPLETED
NA
52 participants
INTERVENTIONAL
2015-01-31
2018-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intervention group
The sit-to-stand training is assisted by mechanical device
Mechanical assisted sit-to-stand training group
Mechanical assisted sit-to-stand training 100 repetitions or 10 mins / session 10 sessions
Control group
The sit-to-stand training is assisted by manual device
Manual assisted sit-to-stand training group
Manual assisted sit-to-stand training 100 repetitions or 10 mins / session 10 sessions
Interventions
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Mechanical assisted sit-to-stand training group
Mechanical assisted sit-to-stand training 100 repetitions or 10 mins / session 10 sessions
Manual assisted sit-to-stand training group
Manual assisted sit-to-stand training 100 repetitions or 10 mins / session 10 sessions
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* any other acute comorbid diseases such as unstable angina, recent myocardial infarction
* unstable medical / psychological condition
ALL
No
Sponsors
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Tai Po Hospital
OTHER_GOV
Responsible Party
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Ng Chee Man, Joey
Principal investigator
Principal Investigators
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Ng Chee Man, Joey, Master
Role: PRINCIPAL_INVESTIGATOR
Tai Po Hospital
Woo Ka Ho, Marc, Master
Role: STUDY_DIRECTOR
Prince of Wales Hospital
Other Identifiers
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2014.427
Identifier Type: -
Identifier Source: org_study_id
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