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

Effects of Multimodal Gait Training With and Without Rhythmic Auditory Stimulation on Coordination, Gait and Risk of Fall in Chronic Stroke Patients

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Stroke Patients
• Intervention / Treatment: Other: Mutimodal gait training includes unilateral step training, inclined treadmill training, over ground training with rhythmic auditory stimulation; Other: Multimodal gait training

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Sialkot, Punjab, Pakistan, 51040
      • Allama Iqbal Memorial Hospital, Islam teaching hospital, National Bone joint Hospital, Amra Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Group A received Multimodal gait training with Rhythmic auditory stimulation	Other: Mutimodal gait training includes unilateral step training, inclined treadmill training, over ground training with rhythmic auditory stimulation; Unilateral step training, inclined treadmill training, over ground training, repetitive isochronous pulses via metronome
Experimental: Group B; Group B Multimodal Gait training without rhythmic auditory stimulation	Other: Multimodal gait training; Unilateral step training, inclined treadmill training, over ground training,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LOWER EXTREMITY MOTOR COORDINATON TEST (LEMCOT)	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	6 weeks
Dynamic gait index (DGI)	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	6 weeks
Fall Efficacy Scale-International (FES-I)	Fall efficacy scale-international (FES- I) is a standardized, short and easy to administer tool evaluates fear of falling and measures concerns about falling	6 weeks

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Binish Afzal, MS-NMPT, Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2024
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): December 5, 2024

Study Registration Dates

• First Submitted: November 18, 2024
• First Submitted That Met QC Criteria: November 18, 2024
• First Posted (Estimated): November 20, 2024

Study Record Updates

• Last Update Posted (Estimated): November 20, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Chronic Stroke; Multimodal; Rhythmic auditory stimulation; Gate Training
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: REC/RCR&AHS/24/0202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No