VIBROACOUSTIC THERAPY in PATIENTS WITH STROKE

Not Applicable

Not yet recruiting

• Conditions: Stroke

• Registration Number: NCT07206485
• Lead Sponsor: October 6 University

Brief Summary

PURPOSE: to investigate the effect of vibroacoustic therapy device with laser motion guidance affect balance sensory integration in patients with stroke BACKGROUND: Following stroke, motor recovery can be dictated by the degree of sensory disruption, The application of vibroacoustic therapy device with laser motion guidance could improve balance and sensory integration functions.

Detailed Description

Forty-four patients post vascular stroke, from both sexes were participated in this study. The patients were randomly divided into four equal groups; Group (I) will receive vibroacoustic therapy and a selected physical therapy program. Group (II) will receive laser motion guidance therapy and a selected physical therapy program. Group (III) will receive vibroacoustic therapy, laser motion guidance and a selected physical therapy program. Group (IV) will receive the selected physical therapy program. The evaluation methods by Biodex balance system using Clinical Test of Sensory Integration and Balance (CTSIB), Time up and go test, and The Functional Independence Measure

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-19
• Study First Submitted QC: 2025-09-26
• Last Update Submitted: 2025-09-26
• Study Start: 2025-10-01
• Study First Posted: 2025-10-03
• Last Update Posted: 2025-10-03
• Primary Completion: 2025-11-15
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Forty-four patients post vascular stroke, according to a sample size calculation
• Both genders (males and females) will participate in the study.
• The age of patients will be from 45 to 60 years.
• The duration of the stroke will be at least 6 months.

Exclusion Criteria

• Other brain injuries/ illnesses, cognitive impairment, serious sensory impairment (superficial, deep, or cortical sensation) or proprioceptive loss, vestibular disorders
• Severe apraxia, severe aphasia
• contractures that restrict patients movement

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Biodex balance system	four weeks	Clinical Test of Sensory Integration and Balance (CTSIB) The Biodex Balance System provides objective, computer-based measurements for the Clinical Test of Sensory Integration and Balance (CTSIB), also known as the Sensory Organization Test (SOT), by quantifying postural sway under various sensory conditions.
Time up and go test (TUG)	four weeks	The TUG is a general physical performance test used to assess mobility, balance, and locomotor performance in elderly people
Biodex balance system Overall Stability Index (OSI)	four weeks	The Biodex Overall Stability Index (OSI) is a composite measure of postural stability provided by the Biodex Balance System (BBS). It quantifies how well a person can maintain balance by measuring the total deviation of the foot platform from level in both anterior-posterior (front-to-back) and medial-lateral (side-to-side) directions

Secondary Outcome Measures

Name	Time	Method
The Functional Independence Measure (FIM) scale	four weeks	The Functional Independence Measure (FIM) is a standardized assessment tool used in rehabilitation to measure a patient's functional ability and level of disability across 18 items, scored on a 1-7 scale, to track progress and guide care plans The FIM assesses a total of 18 items across six categories-self-care, sphincter control, mobility, locomotion, communication, and social cognition-each focusing on essential daily activities.