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Completed

NCT Number: NCT07206485

Vibroacoustic Therap in Patients With Stroke

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.

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Key information

Conditions

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

Age range

45 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lama Saad El-Din Mahmoud

Al Jīzah, Select State, 0020, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vibro-acoustic therapy

Device

Vibroacoustic therapy (VAT) is a type of sound therapy that involves passing low frequency sine wave vibrations into the body via a device with embedded speakers

Motion Guidance Laser

Device

Motion Guidance Laser is a tool used to improve the curative progression by leading to excessive participation of the subject, helping to facilitate motor skills, postural stability

selected physical therapy exercises program

Other
  • Passive Prolonged Stretching and positioning
  • Range of motion exercises for both upeer limb and lower limb
  • Balance exercises static and dynamic

Primary outcomes

  1. Biodex balance system

    Time frame: 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.

  2. Time up and go test (TUG)

    Time frame: four weeks

    The TUG is a general physical performance test used to assess mobility, balance, and locomotor performance in elderly people

  3. Biodex balance system Overall Stability Index (OSI)

    Time frame: 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 outcomes

  1. The Functional Independence Measure (FIM) scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

October 6 University

Other

Registry information

Official study title

Effect of Vibroacoustic Therapy Device With Laser Motion Guidance on Balance Sensory Integration in Patients With Stroke

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Oct 3, 2025
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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