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"Bilateral Training in Stroke Patients"

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bilateral training (BAT)
Sponsored by
Shifa International Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • left or right-sided chronic stroke patients

Exclusion Criteria:

  • Patients with cognitive impairment or unable to follow commands

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Right hemiplegic patients

    Left hemiplegic patients

    Arm Description

    Outcomes

    Primary Outcome Measures

    Wolf Motor Function Test
    The Wolf Motor Function Test (WMFT) was used to assess upper extremity (UE) motor ability through timed and functional tasks
    Fugl Meyer Assessment-upper Extremity
    Used to measure upper limb sensorimotor function in stroke patients

    Secondary Outcome Measures

    Full Information

    First Posted
    December 3, 2018
    Last Updated
    April 1, 2019
    Sponsor
    Shifa International Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03762980
    Brief Title
    "Bilateral Training in Stroke Patients"
    Official Title
    Effect of Bilateral Training for Upper Extremities in Chronic Stroke Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1, 2016 (Actual)
    Primary Completion Date
    September 1, 2016 (Actual)
    Study Completion Date
    December 1, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shifa International Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    The objective of this study was to evaluate the effects of bilateral training for upper extremity in stroke patients and to compare these effects between right and left stroke patients. A Quasi Experimental Study conducted on community stroke survivors. A total of 24 stroke patients were included and divided into Group A (Right hemiplegia) (n=12) and Group B (Left hemiplegia) (n=12). Chronic stroke patients (>3 months), aged 30-70 years with left or right sided diagnosed stroke patients were included while patients on medication that could affect the cognitive functions or with any other cognitive impairments who are not able to follow commands were excluded. Both groups received the same intervention of with bilateral arm training involving 5 functional tasks to improve the functional activities of daily living in upper extremities. Fugl-Meyer Assessment-Upper Extremity Tool (FMA-UE) and Wolf-Motor Function Test (WMFT) were used to assess as outcome measures.The measurements were obtained at baseline and after 6th week of training. Data was analyzed using SPSS version 21.

    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
    Single Group Assignment
    Masking
    Outcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Right hemiplegic patients
    Arm Type
    Experimental
    Arm Title
    Left hemiplegic patients
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    Bilateral training (BAT)
    Intervention Description
    Each group received bilateral training) for upper extremities for 3 days per week for 01 hour/day for up to 6 weeks. Tasks included functional tasks such as stacking cones and cups, positioning the cup upright, throw a ball into basket, carrying a wooden block and buttoning and unbuttoning of shirt with counting. Each task was performed for 10 minutes and had a rest break of 1 minute.
    Primary Outcome Measure Information:
    Title
    Wolf Motor Function Test
    Description
    The Wolf Motor Function Test (WMFT) was used to assess upper extremity (UE) motor ability through timed and functional tasks
    Time Frame
    6 weeks
    Title
    Fugl Meyer Assessment-upper Extremity
    Description
    Used to measure upper limb sensorimotor function in stroke patients
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: left or right-sided chronic stroke patients Exclusion Criteria: Patients with cognitive impairment or unable to follow commands

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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