- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03762980
"Bilateral Training in Stroke Patients"
April 1, 2019 updated by: Humera Ambreen, Shifa International Hospital
Effect of Bilateral Training for Upper Extremities in Chronic Stroke Patients
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- left or right-sided chronic stroke patients
Exclusion Criteria:
- Patients with cognitive impairment or unable to follow commands
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Right hemiplegic patients
|
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.
|
|
EXPERIMENTAL: Left hemiplegic patients
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Wolf Motor Function Test
Time Frame: 6 weeks
|
The Wolf Motor Function Test (WMFT) was used to assess upper extremity (UE) motor ability through timed and functional tasks
|
6 weeks
|
|
Fugl Meyer Assessment-upper Extremity
Time Frame: 6 weeks
|
Used to measure upper limb sensorimotor function in stroke patients
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 1, 2016
Primary Completion (ACTUAL)
September 1, 2016
Study Completion (ACTUAL)
December 1, 2016
Study Registration Dates
First Submitted
December 3, 2018
First Submitted That Met QC Criteria
December 3, 2018
First Posted (ACTUAL)
December 4, 2018
Study Record Updates
Last Update Posted (ACTUAL)
April 3, 2019
Last Update Submitted That Met QC Criteria
April 1, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 563-011-2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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University of FloridaRecruiting
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