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Comparative Effects of Backward Treadmill Walking and Lower Extremity Cross Training Among Stroke Patients

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Backward treadmill walking
Lower extremity cross training
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

55 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Safi teaching hospital FaisalabadRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Backward treadmill walking group

Lower extremity cross training

Arm Description

Outcomes

Primary Outcome Measures

Lower Extremity Functional Scale (LEFS)
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
Tinetti Performance Oriented Mobility Assessment (POMA)
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.

Secondary Outcome Measures

Full Information

First Posted
April 18, 2023
Last Updated
April 18, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05834192
Brief Title
Comparative Effects of Backward Treadmill Walking and Lower Extremity Cross Training Among Stroke Patients
Official Title
Comparative Effects of Backward Treadmill Walking and Lower Extremity Cross Training on Gross Motor Function and Balance Among Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 25, 2023 (Actual)
Primary Completion Date
October 18, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

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

5. Study Description

Brief Summary
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

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
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Backward treadmill walking group
Arm Type
Experimental
Arm Title
Lower extremity cross training
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Backward treadmill walking
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Lower extremity cross training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lower Extremity Functional Scale (LEFS)
Description
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
Time Frame
8 weeks
Title
Tinetti Performance Oriented Mobility Assessment (POMA)
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hira Jabeen, Masters
Phone
+923234116506
Email
hira.jabeen@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Touseeq Ahmad, MS-PT (NMPT)
Phone
+923018199862
Email
Tousiq875@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hira Jabeen, Masters
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Safi teaching hospital Faisalabad
City
Faisalābad
State/Province
Punjab
ZIP/Postal Code
38000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shahid Shafique, DPT
Phone
03326649539
Email
shahidshafiq777@gmail.com
First Name & Middle Initial & Last Name & Degree
Touseeq Ahmad, Masters

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparative Effects of Backward Treadmill Walking and Lower Extremity Cross Training Among Stroke Patients

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