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.

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Mechanical assisted sit-to-stand training group; Other: Manual assisted sit-to-stand training group

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; The sit-to-stand training is assisted by mechanical device	Device: Mechanical assisted sit-to-stand training group; Mechanical assisted sit-to-stand training 100 repetitions or 10 mins / session 10 sessions; Other Names: sit-to-stand trainer
Active Comparator: Control group; The sit-to-stand training is assisted by manual device	Other: Manual assisted sit-to-stand training group; Manual assisted sit-to-stand training 100 repetitions or 10 mins / session 10 sessions; Other Names: physiotherapist assisted

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Sit-to-Stand Test (SST) from the Balance Master®	To assess the quality of sit-to-stand of patient	After 10 sessions of training
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

Collaborators and Investigators

• Sponsor: Tai Po Hospital
• Investigators: Principal Investigator: Ng Chee Man, Joey, Master, Tai Po Hospital; Study Director: Woo Ka Ho, Marc, Master, Prince of Wales Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: August 31, 2017
• First Submitted That Met QC Criteria: September 1, 2017
• First Posted (Actual): September 6, 2017

Study Record Updates

• Last Update Posted (Actual): September 6, 2018
• Last Update Submitted That Met QC Criteria: September 4, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2014.427

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No