Clinical trial NCT06696950: Multimodal Gait Training With and Without Rhythmic Auditory Stimulation in Chronic Stroke Patients
Official title: Effects of Multimodal Gait Training With and Without Rhythmic Auditory Stimulation on Coordination, Gait and Risk of Fall in Chronic Stroke Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Stroke Patients
Keywords: Chronic Stroke
Gate Training
Multimodal
Rhythmic auditory stimulation
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 42
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: LOWER EXTREMITY MOTOR COORDINATON TEST (LEMCOT)
timeFrame: 6 weeks
measure: Dynamic gait index (DGI)
timeFrame: 6 weeks
measure: Fall Efficacy Scale-International (FES-I)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sialkot
country: Pakistan
facility: Allama Iqbal Memorial Hospital, Islam teaching hospital, National Bone joint Hospital, Amra Medical Center
state: Punjab
Study officials:
affiliation: Riphah International University
name: Binish Afzal, MS-NMPT
role: PRINCIPAL_INVESTIGATOR
References: