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

NCT06567223 | Active Not Recruiting DMC

• 1 other identifier: MSRSW/Batch-Fall22/737
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Vibration Therapy

EXPERIMENTAL

Procedure: Vibration Therapy

Rhythmic auditory stimulation therapy.

ACTIVE COMPARATOR

Combination Product: Rhythmic auditory stimulation therapy.

Interventions

Vibration Therapy 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

Vibration Therapy

Rhythmic auditory stimulation therapy. 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

Rhythmic auditory stimulation therapy.

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Superior University: lead

Study Sites (2)

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

Lahore, Punjab Province, Pakistan

Location

Sehat Medical Complex, Hanjerwal

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 22, 2024
• Study Start: October 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: September 30, 2024
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)