Clinical Trials Directory

Trials / Completed

CompletedNCT03273101

Sit-to-stand Training in Stroke Patient

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.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
52 (actual)
Sponsor
Tai Po Hospital · Other Government
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEMechanical assisted sit-to-stand training groupMechanical assisted sit-to-stand training 100 repetitions or 10 mins / session 10 sessions
OTHERManual assisted sit-to-stand training groupManual assisted sit-to-stand training 100 repetitions or 10 mins / session 10 sessions

Timeline

Start date
2015-01-01
Primary completion
2017-03-01
Completion
2018-05-01
First posted
2017-09-06
Last updated
2018-09-06

Source: ClinicalTrials.gov record NCT03273101. Inclusion in this directory is not an endorsement.