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Sit-to-stand Training in Stroke Patient

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mechanical assisted sit-to-stand training group
Manual assisted sit-to-stand training group
Sponsored by
Tai Po Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intervention group

    Control group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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
    Sit-to-Stand Test (SST) from the Balance Master®
    To assess the quality of sit-to-stand of patient
    Five-Repetition Sit-to-Stand Test
    To assess the functional strength of lower limb, balance and transition move of patient

    Secondary Outcome Measures

    Full Information

    First Posted
    August 31, 2017
    Last Updated
    September 4, 2018
    Sponsor
    Tai Po Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03273101
    Brief Title
    Sit-to-stand Training in Stroke Patient
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (Actual)
    Primary Completion Date
    March 2017 (Actual)
    Study Completion Date
    May 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tai Po Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    52 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Description
    The sit-to-stand training is assisted by mechanical device
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    The sit-to-stand training is assisted by manual device
    Intervention Type
    Device
    Intervention Name(s)
    Mechanical assisted sit-to-stand training group
    Other Intervention Name(s)
    sit-to-stand trainer
    Intervention Description
    Mechanical assisted sit-to-stand training 100 repetitions or 10 mins / session 10 sessions
    Intervention Type
    Other
    Intervention Name(s)
    Manual assisted sit-to-stand training group
    Other Intervention Name(s)
    physiotherapist assisted
    Intervention Description
    Manual assisted sit-to-stand training 100 repetitions or 10 mins / session 10 sessions
    Primary Outcome Measure Information:
    Title
    Number of patients regained the independence of sit-to-stand
    Description
    To compare how many patients can regain the independence of sit-to-stand between groups
    Time Frame
    After 10 sessions of training
    Title
    Sit-to-Stand Test (SST) from the Balance Master®
    Description
    To assess the quality of sit-to-stand of patient
    Time Frame
    After 10 sessions of training
    Title
    Five-Repetition Sit-to-Stand Test
    Description
    To assess the functional strength of lower limb, balance and transition move of patient
    Time Frame
    After 10 sessions of training

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ng Chee Man, Joey, Master
    Organizational Affiliation
    Tai Po Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Woo Ka Ho, Marc, Master
    Organizational Affiliation
    Prince of Wales Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Sit-to-stand Training in Stroke Patient

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