- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05834192
Comparative Effects of Backward Treadmill Walking and Lower Extremity Cross Training Among Stroke Patients
Comparative Effects of Backward Treadmill Walking and Lower Extremity Cross Training on Gross Motor Function and Balance Among Stroke Patients
Stroke is one of the high rated neurological disorders, induced by disruption of brain's blood flow. Stroke can alter the level of consciousness, motor and cognitive skills, sensory perception and language; it all depends on the extent of injury and the region of brain that is affected. Even though all the rehabilitation given to the "stroke" patients, but still 25-30% of the survivors still have gait and balance problem and they require complete physical support before their discharge from the hospital. Backward treadmill walking has reported numerous benefits in improving balance, motor function and gait. Cross training is a technique which is applied to healthy limb of the individual to increase muscle strength and muscle activity.so the aim of this study is to find the effects of backward treadmill walking and lower extremity cross training on gross motor function and balance among stroke patients.
The study will be randomized clinical trials, Participants will be randomly allocated into two groups each group will have 13. This study will be conducted in Safi teaching Hospital Faisalabad. Group A will be treated with backward treadmill walking and group B will be treated with lower extremity cross training. All participants will receive conventional physical exercises which includes general mobility and functional activities. In this study, the 40-minute training programs for both groups will be occur 5 times a week for 6 weeks, with 5 minutes being allocated for warm up, 30 minutes devoted to the main exercise, and 5 minutes for cool down. Outcome will be measured before and after giving treatment by using Tinetti performance oriented mobility assessment and lower extremity functional scale. The results will be calculated by using SPSS version 25. Frequencies and mean standard deviation will be measured, parametric and non-parametric tests will be applied
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hira Jabeen, Masters
- Phone Number: +923234116506
- Email: hira.jabeen@riphah.edu.pk
Study Contact Backup
- Name: Touseeq Ahmad, MS-PT (NMPT)
- Phone Number: +923018199862
- Email: Tousiq875@gmail.com
Study Locations
-
-
Punjab
-
Faisalābad, Punjab, Pakistan, 38000
- Recruiting
- Safi teaching hospital Faisalabad
-
Contact:
- Shahid Shafique, DPT
- Phone Number: 03326649539
- Email: shahidshafiq777@gmail.com
-
Principal Investigator:
- Touseeq Ahmad, Masters
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Hemiplegic stroke patient diagnosed within last 6 months to 1 year
- Age 55 to 75 years
- Cognition score on Mini-mental state examination > 24
- Able to independently walk 10 m without walking aids
- Able to understand instructions
Exclusion Criteria:
- Who will have visual or vestibular injury
- Patients having history of orthopedic surgery or having an orthopedic condition
- Who will have >grade 2 on modified Ashworth Scale (MAS)
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: Backward treadmill walking group
|
Backward Treadmill walking will be given to this group.
Speed settings of treadmill will be established based on the previous motor function of participants.
All participants will receive conventional physical exercises which includes general mobility and functional activities.
In this study, the 40-minute training programs for both groups will be occur 5 times a week for 6 weeks, with 5 minutes being allocated for warm up, 30 minutes devoted to the main exercise, and 5 minutes for cool down.
|
Active Comparator: Lower extremity cross training
|
For cross-training, a strong resistance will be applied by the therapist until a response will be achieved on the contralateral lower extremity at the end range of motion. Resistance will be consistently applied for 10 seconds once a response will be achieved. All participants will receive conventional physical exercises which includes general mobility and functional activities. In this study, the 40-minute training programs for both groups will be occur 5 times a week for 6 weeks, with 5 minutes being allocated for warm up, 30 minutes devoted to the main exercise, and 5 minutes for cool down. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lower Extremity Functional Scale (LEFS)
Time Frame: 8 weeks
|
It consists of 20 questions designed to assess a person's ability to perform everyday tasks, such as getting into or out of the bath, walking between rooms, squatting, and sitting for 1 hour.
Performance is rated on a 5-point scale with maximum score of 80. Lower score shows greater disability
|
8 weeks
|
Tinetti Performance Oriented Mobility Assessment (POMA)
Time Frame: 8 weeks
|
it comprises 16 items (9 balance-related and 7 gait-related items).
The highest achievable score being 28 points (16 for balance and 12 for gait).
A higher score indicates better balance.
A cutoff score greater than 17 points has been associated with fall risk in the older adult population.
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hira Jabeen, Masters, Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/23/0221
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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