NCT05834192

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 28, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2023

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

April 28, 2023

Status Verified

April 1, 2023

Enrollment Period

8 months

First QC Date

April 18, 2023

Last Update Submit

April 18, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Backward treadmill walking group

EXPERIMENTAL
Other: Backward treadmill walking

Lower extremity cross training

ACTIVE COMPARATOR
Other: Lower extremity cross training

Interventions

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.

Backward treadmill walking group

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.

Lower extremity cross training

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Safi teaching hospital Faisalabad

Faisalābad, Punjab Province, 38000, Pakistan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Hira Jabeen, Masters

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hira Jabeen, Masters

CONTACT

Touseeq Ahmad, MS-PT (NMPT)

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2023

First Posted

April 28, 2023

Study Start

February 25, 2023

Primary Completion

October 18, 2023

Study Completion

October 30, 2023

Last Updated

April 28, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations