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

NCT ID: NCT06696950

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-10
• Study Completion Date: 2024-12-05

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A

Group A received Multimodal gait training with Rhythmic auditory stimulation

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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

Group B

Group B Multimodal Gait training without rhythmic auditory stimulation

Group Type: EXPERIMENTAL

Multimodal gait training

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Multimodal gait training

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Binish Afzal, MS-NMPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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

Sialkot, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

REC/RCR&AHS/24/0202

Identifier Type: -

Identifier Source: org_study_id