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

Effectiveness of Whole-Body Vibration Versus Rhythmic Auditory Stimulation on Spasticity, Balance, and Lower Limb Motor Function on Hemiplegic Stroke Patients

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stroke
• Intervention / Treatment: Procedure: Vibration Therapy; Combination product: Rhythmic auditory stimulation therapy.

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.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan
      • Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University
    • Lahore, Punjab, Pakistan
      • Sehat Medical Complex, Hanjerwal

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vibration Therapy	Procedure: 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
Active Comparator: Rhythmic auditory stimulation therapy.	Combination product: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Ashworth Scale	Modified Ashworth Scale is a scale which is used to assess spasticity in a patient. It is range from 0 to 4 where 0 shows no muscle tone with no range to 4 which shows maximum muscle tone with full range..	12 Months
Berg balance scale	Balance was measured by using BBS which was created in 1989 to measure balance in the older people. The Berg balance scale 27 assesses practical balance performance on 14 things normal to everyday life. The scale comprises of 14 items, scored from 0 to 4, which are added to make an all-out score somewhere in the range of 0 and 56; a higher score shows better balance	12 months
Fugl-Meyer Assessment (FMA)	Fugl-Meyer Assessment (FMA) for Lower Limb. In order to assess the lower extremity motor control fugal Meyer assessment test which is a strokes specific test was used to assess the motor function balance and sensation in stroke patients. Its scoring is through 3 point ordinal scale where 2 is performed fully and 1 is performed partially. It has a maximum score of 34	12 months

Collaborators and Investigators

• Sponsor: Superior University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): June 1, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: August 8, 2024
• First Submitted That Met QC Criteria: August 21, 2024
• First Posted (Actual): August 22, 2024

Study Record Updates

• Last Update Posted (Actual): August 22, 2024
• Last Update Submitted That Met QC Criteria: August 21, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: MSRSW/Batch-Fall22/737

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