Clinical trial NCT03273101: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Tai Po Hospital
Sponsor class: OTHER_GOV
First posted: 2017-09-06
Enrollment: 52
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of patients regained the independence of sit-to-stand
timeFrame: After 10 sessions of training
measure: Sit-to-Stand Test (SST) from the Balance Master®
timeFrame: After 10 sessions of training
measure: Five-Repetition Sit-to-Stand Test
timeFrame: After 10 sessions of training
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tai Po Hospital
name: Ng Chee Man, Joey, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Prince of Wales Hospital
name: Woo Ka Ho, Marc, Master
role: STUDY_DIRECTOR
References: