"Bilateral Training in Stroke Patients"
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bilateral training (BAT)
Sponsored by

About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
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
NCT ID
NCT03762980
First Posted
December 3, 2018
Last Updated
April 1, 2019
Sponsor
Shifa International Hospital
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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"Bilateral Training in Stroke Patients"
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