Sit-to-stand Training in Stroke Patient

NCT03273101 | Completed

• 1 other identifier: 2014.427
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Intervention group

EXPERIMENTAL

The sit-to-stand training is assisted by mechanical device

Device: Mechanical assisted sit-to-stand training group

Control group

ACTIVE COMPARATOR

The sit-to-stand training is assisted by manual device

Other: Manual assisted sit-to-stand training group

Interventions

Mechanical assisted sit-to-stand training group DEVICE

Mechanical assisted sit-to-stand training 100 repetitions or 10 mins / session 10 sessions

Also known as: sit-to-stand trainer

Intervention group

Manual assisted sit-to-stand training group OTHER

Manual assisted sit-to-stand training 100 repetitions or 10 mins / session 10 sessions

Also known as: physiotherapist assisted

Control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tai Po Hospital: lead

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ng Chee Man, Joey, Master

  Tai Po Hospital

  PRINCIPAL INVESTIGATOR

• Woo Ka Ho, Marc, Master

  Prince of Wales Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 31, 2017
• First Posted: September 6, 2017
• Study Start: January 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: May 1, 2018
• Last Updated: September 6, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share