Effectiveness of WBV Versus RAS on Spasticity, Balance, and Lower Limb Motor Function on Hemiplegic Stroke Patients

NCT ID: NCT06567223

Last Updated: 2024-08-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-09-30

Brief Summary

This study investigates the effectiveness of whole-body vibration (WBV) versus rhythmic auditory stimulation (RAS) on spasticity, balance, and lower limb motor function in hemiplegic stroke patients. The objective was to compare the two interventions to determine which provides greater benefits in stroke rehabilitation. Hemiplegic stroke patients were randomly assigned to either the WBV group, receiving whole-body vibration therapy, or the RAS group, undergoing rhythmic auditory stimulation sessions.

Detailed Description

The study measured spasticity using the Modified Ashworth Scale (MAS), balance with the Berg Balance Scale (BBS), and lower limb motor function through the Fugl-Meyer Assessment (FMA). Results indicated that both WBV and RAS significantly improved spasticity, balance, and lower limb motor function.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Vibration Therapy

Group Type: EXPERIMENTAL

Vibration Therapy

Intervention Type: PROCEDURE

will receive the whole body vibration therapy. Patient will be ask to stand on the vibration plate in semi flexed knee position will 3 minute time of rest and therapy. It will be given for four weeks three days per week. Acceleration will be 18.0 meter per second square and frequency will be from 30 to 40 Hz. Intensity of the therapy will increase throughout all the sessions

Rhythmic auditory stimulation therapy.

Group Type: ACTIVE_COMPARATOR

Rhythmic auditory stimulation therapy.

Intervention Type: COMBINATION_PRODUCT

will receive rhythmic auditory stimulation therapy. Rhythmic auditory stimulation will be given for 90 minutes along with 30 minutes of conventional physiotherapy. It will consist of 15 minutes of general body warming metronome rhythm which proceed towards RAS music based exercise of 60 minutes. This period also ends up with 15 minutes of relaxation exercise. Relaxing Music was provided through headphones having voice cancellation property for 15 min. The total session will be given three days per week for four weeks. Exercises such as lateral walking military march, anterior walking, one toe and one heel walking along with posterior walking through progression with the speed of the rhythm is done

Interventions

Vibration Therapy

will receive the whole body vibration therapy. Patient will be ask to stand on the vibration plate in semi flexed knee position will 3 minute time of rest and therapy. It will be given for four weeks three days per week. Acceleration will be 18.0 meter per second square and frequency will be from 30 to 40 Hz. Intensity of the therapy will increase throughout all the sessions

Intervention Type: PROCEDURE

Rhythmic auditory stimulation therapy.

will receive rhythmic auditory stimulation therapy. Rhythmic auditory stimulation will be given for 90 minutes along with 30 minutes of conventional physiotherapy. It will consist of 15 minutes of general body warming metronome rhythm which proceed towards RAS music based exercise of 60 minutes. This period also ends up with 15 minutes of relaxation exercise. Relaxing Music was provided through headphones having voice cancellation property for 15 min. The total session will be given three days per week for four weeks. Exercises such as lateral walking military march, anterior walking, one toe and one heel walking along with posterior walking through progression with the speed of the rhythm is done

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• Participant with Age from 40 to 60 years
• Both males and females
• Diagnosed CVA patients
• Chronic stage (after 6 months of onset
• Individuals with BBS score ≥ 20 ≤ 40
• FMI score up to 3(moderate assistance)
• Able to understand command
• Mini-Mental State Examination (MMSE) score of over 20

Exclusion Criteria

• Systematic Disorder e.g. Rheumatoid arthritis
• Unstable Angina
• Coexisting physical impairments e.g. limb amputation
• Any previous history of neurological disease other than stroke e.g. Parkinson's
• Any previous history of fractures
• Hearing or perception deficits
• Individuals unable to adhere to the study protocol or attend scheduled follow-up visits.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Superior University

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Naveed Babur

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University

Lahore, Punjab Province, Pakistan

Sehat Medical Complex, Hanjerwal

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

MSRSW/Batch-Fall22/737

Identifier Type: -

Identifier Source: org_study_id