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

NCT ID: NCT05834192

Last Updated: 2023-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-25

Study Completion Date

2023-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Backward treadmill walking group

Group Type EXPERIMENTAL

Backward treadmill walking

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

Lower extremity cross training

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Riphah International University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hira Jabeen, Masters

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Safi teaching hospital Faisalabad

Faisalābad, Punjab Province, Pakistan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Hira Jabeen, Masters

Role: CONTACT

Phone: +923234116506

Email: [email protected]

Touseeq Ahmad, MS-PT (NMPT)

Role: CONTACT

Phone: +923018199862

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Shahid Shafique, DPT

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REC/RCR&AHS/23/0221

Identifier Type: -

Identifier Source: org_study_id