- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07576153
Effects of Unilateral Versus Bilateral Task Specific Training With Visual Feedback in Post Stroke Patients
Effects of Unilateral Versus Bilateral Task Specific Training With Visual Feedback on Lower Limb on Balance, Gait and Sensation in Post Stroke Patients
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Lahore, Pakistan, 54000
- Department of Physical Therapy, Sahet Medical complex Lahore
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 40-65 years
- Both gender male and female
- Pre diagnose with the Stroke
- Patient with a subacute phase (>3months post stroke)
- Ability to understand and follow the instructions (8)
- Berg Balance Scale (BBS) score between 21-40
- 10 meter walk test (0.4-0.8m/s)
Exclusion Criteria:
- Severe cognitive Impairment
- Visual and vestibular Impairment
- Other orthopedic or neurological disorder
- unilateral neglect
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: bilateral task specific training with visual feedback
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The group will received bilateral task specific training along with visual feedback on lower limb.
Bilateral training is used in rehabilitation to promote functional recovery of impaired limbs by engaging both affected and non-affected sides.
Task specific training include weight shifting, sit to stand, stepping forward / lateral and bilateral walking over uneven surfaces.
Visual feedback will be given by mirrors and visual targets place on the floor.
Visual feedback helping patients to improve balance and body awareness, particularly for individuals with sensory or motor impairments following a stroke.
Bilateral task specific training with visual feedback will perform for five days per week for six weeks.
The participants in this group underwent 40 minutes of bilateral lower limb training.
Pre and post intervention values will be recorded to assess the effectiveness
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Experimental: unilateral task specific training with visual feedback
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This group received unilateral task specific training with visual feedback on affected limb.
Task specific training include weight shifting, seated marching, stepping forward / lateral, and walk on uneven surface.
Unilateral task specific training with visual feedback will perform for five days per week for six weeks.
The participants in this group underwent 40 minutes of unilateral lower limb training.
Pre and post intervention values will be recorded to assess the effectiveness.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Berg Balance Scale
Time Frame: 6 weeks
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Berg balance (BBG) is a widely used clinical test to assess a person's static and dynamic balance abilities. It consist of 14 performance based tasks each scored on a 5 point scale from 0 to 4 for a maximum total score of 56. It used for individuals with balance impairments such as post stroke patients. In scoring criteria 4 score perform task independently and safely, 3 score perform with supervision or slight assistance, 2 score perform with moderate assistance or deviation, 1score perform with major assistance and 0 score unable to perform The scoring range 41-56 low risk balance impairment, 21-40 moderate risk balance impairment and 0-20 high risk balance impairment Test retest (ICC =0.96; 95% CI, 0.93-0.98) and inter-rater (ICC=0.93; 95% CI, 0.87=0.97) reliability was excellent |
6 weeks
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Meter Walk Test (TMWT)
Time Frame: 6 weeks
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10 meter walk test is use to assess the gait and gait speed over a short distance.
It is an important predictor of functional independence, fall risk and community mobility.
It is perform by the patient to walk a total 14 meter at a comfortable speed, only the middle 10 meter are timed to eliminate acceleration and deceleration bias.
First 2 meter acceleration, middle 10 meter time walking and last 2 meter deceleration.
Repeat the test twice.
The Scoring of 10 meter walk test have predicted values, gait speed < 0.4 m/ s functional status (household ambulation), 0.4 - 0.8 m/s limited community ambulation, > 0.8 m/s community ambulation and > 1.2 m/s safe for crossing the street
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6 weeks
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Fugl- Meyer Assessment - Lower Extremity
Time Frame: 06 weeks
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Fugl Meyer Assessment Lower Extremity is widely used outcome tool to measure in rehabilitation, particularly for stroke patients. To measure the sensation, it include light touch sensation and proprioception. The scoring criteria each item is on a 3 point scale; 0 unable to perform the task, 1 impaired and 2 normal. The total score ranges from 0 to 10. Light touch 2 sites and 2 points total score 4. Proprioception 3 joints 2 points total score 6 |
06 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Zain Ul Abbas, Ms, Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/25/0223
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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