Sit-to-stand Training in Stroke Patient

Stroke Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03273101
• Other study ID #: 2014.427
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: May 2018

Study information

• Verified date: September 2018
• Source: Tai Po Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 2018
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Mechanical assisted sit-to-stand training group
Mechanical assisted sit-to-stand training 100 repetitions or 10 mins / session 10 sessions

Other:
• Manual assisted sit-to-stand training group
Manual assisted sit-to-stand training 100 repetitions or 10 mins / session 10 sessions

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tai Po Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Sit-to-Stand Test (SST) from the Balance Master®	To assess the quality of sit-to-stand of patient	After 10 sessions of training
Primary	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