Sit-to-stand Training in Stroke Patient

Sponsor
Tai Po Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03273101
Collaborator
(none)
52
2
40

Study Details

Study Description

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 masterĀ® 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Mechanical assisted sit-to-stand training group
  • Other: Manual assisted sit-to-stand training group
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
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.
Actual Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Mar 1, 2017
Actual Study Completion Date :
May 1, 2018

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Number of patients regained the independence of sit-to-stand [After 10 sessions of training]

      To compare how many patients can regain the independence of sit-to-stand between groups

    2. Sit-to-Stand Test (SST) from the Balance MasterĀ® [After 10 sessions of training]

      To assess the quality of sit-to-stand of patient

    3. Five-Repetition Sit-to-Stand Test [After 10 sessions of training]

      To assess the functional strength of lower limb, balance and transition move of patient

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ng Chee Man, Joey, Principal investigator, Tai Po Hospital
    ClinicalTrials.gov Identifier:
    NCT03273101
    Other Study ID Numbers:
    • 2014.427
    First Posted:
    Sep 6, 2017
    Last Update Posted:
    Sep 6, 2018
    Last Verified:
    Sep 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 6, 2018