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

NCT06696950 | Active Not Recruiting

• 1 other identifier: REC/RCR&AHS/24/0202
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Stroke Patients

Keywords

Chronic Stroke; Gate Training; Multimodal; Rhythmic auditory stimulation

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Group A

EXPERIMENTAL

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

Group B

EXPERIMENTAL

Group B Multimodal Gait training without rhythmic auditory stimulation

Other: Multimodal gait training

Interventions

Mutimodal gait training includes unilateral step training, inclined treadmill training, over ground training with rhythmic auditory stimulation OTHER

Unilateral step training, inclined treadmill training, over ground training, repetitive isochronous pulses via metronome

Group A

Multimodal gait training OTHER

Unilateral step training, inclined treadmill training, over ground training,

Group B

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Allama Iqbal Memorial Hospital, Islam teaching hospital, National Bone joint Hospital, Amra Medical Center

Sialkot, Punjab Province, 51040, Pakistan

Location

Study Officials

• Binish Afzal, MS-NMPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 20, 2024
• Study Start: January 10, 2024
• Primary Completion: November 30, 2024
• Study Completion: December 5, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)