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

Stroke Clinical Trial

Official title:

Comparative Effects of Backward Treadmill Walking and Lower Extremity Cross Training on Gross Motor Function and Balance Among Stroke Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05834192
• Other study ID #: REC/RCR&AHS/23/0221
• Status: Recruiting
• Phase: N/A
• Start date: February 25, 2023
• Est. completion date: October 30, 2023

Study information

• Verified date: April 2023
• Source: Riphah International University
• Contact: Hira Jabeen, Masters
• Phone: +923234116506
• Email: hira.jabeen[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: October 30, 2023
• Est. primary completion date: October 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Backward treadmill walking
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.
• 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.

Locations

Country	Name	City	State
Pakistan	Safi teaching hospital Faisalabad	Faisalabad	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	8 weeks
Primary	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.	8 weeks