Multimodal Gait Training With and Without Rhythmic Auditory Stimulation in Chronic Stroke Patients

Not Applicable

Active, not recruiting

• Conditions: Chronic Stroke Patients

• Registration Number: NCT06696950
• Lead Sponsor: Riphah International University

Brief Summary

The primary goal of this randomized clinical trial is to investigate the efficacy of multimodal gait training, with and without rhythmic auditory stimulation, in improving gait, coordination and reducing fall risk in individuals with chronic stroke This clinical trial features two distinct groups 42 participants were randomly divided into two groups of 21. Group A will receive Multimodal gait training along with rhythmic auditory stimulation while Group B will receive only multimodal gait training

Participants will:

* Take 12 sessions of the MMGT program over six weeks

* With each session lasting 45 minutes, including 10-minute rest breaks.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2024-01-10
• Status Verified: 2024-11
• Study First Submitted: 2024-11-18
• Study First Submitted QC: 2024-11-18
• Last Update Submitted: 2024-11-18
• Study First Posted: 2024-11-20
• Last Update Posted: 2024-11-20
• Primary Completion: 2024-11-30
• Study Completion: 2024-12-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Participants of age between 45 and 70 year
• Participants of both genders were included.
• Participants who were able to walk independently indoors without walking aid
• Participants were included if they had lower limb motor impairment (Fugl-Meyer Assessment lower extremity (FMLE) score less than score less than 34
• Participants with stroke lasting longer than six months
• Participants with Mini-Mental Status Examination score 24 or more than 24
• Participants with the capability to keep in sitting position for 30 minutes
• Participants with the history of fall in the past year
• Participants with no visual or auditory impairments that would interfere with the training

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Exclusion Criteria

• Participants with respiratory problems.
• Participants with any orthopedic condition.
• Participants with aphasia that impeded communication.
• Participants with have severe cardiac disease.
• Participants with resistant hypertension despite use of medication (average systolic blood pressure ≥ 140 mmHg or average diastolic blood pressure ≥ 90 mmHg measured over 7 days)
• Participants with presence of non-healing ulcers in the lower limbs, and osteoporosis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
LOWER EXTREMITY MOTOR COORDINATON TEST (LEMCOT)	6 weeks	The Lower Extremity Motor Coordination test (LEMCOT) is a clinically useful performance-based test to assess coordination improvements of lower limb in post-stroke individuals
Dynamic gait index (DGI)	6 weeks	The dynamic gait index is a comprehensive clinical assessment performance based tool used designed to evaluate gait-related task such as dynamic balance, gait and risk of fall in older adults with various neurological conditions
Fall Efficacy Scale-International (FES-I)	6 weeks	Fall efficacy scale-international (FES- I) is a standardized, short and easy to administer tool evaluates fear of falling and measures concerns about falling

Trial Locations

Locations (1)

Allama Iqbal Memorial Hospital, Islam teaching hospital, National Bone joint Hospital, Amra Medical Center; 🇵🇰 Sialkot, Punjab, Pakistan