VIBROACOUSTIC THERAPY in PATIENTS WITH STROKE

NCT ID: NCT07206485

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2025-12-30

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

Conditions

Stroke

Study Design

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

Study Groups

Group (I)

will receive vibroacoustic therapy and a selected physical therapy program.

Group Type: EXPERIMENTAL

vibro-acoustic therapy

Intervention Type: 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

selected physical therapy exercises program

Intervention Type: OTHER

1. Passive Prolonged Stretching and positioning

2. Range of motion exercises for both upeer limb and lower limb

3. Balance exercises static and dynamic

Group (II)

laser motion guidance therapy and a selected physical therapy program

Group Type: EXPERIMENTAL

Motion Guidance Laser

Intervention Type: 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

Intervention Type: OTHER

1. Passive Prolonged Stretching and positioning

2. Range of motion exercises for both upeer limb and lower limb

3. Balance exercises static and dynamic

Group (III)

vibroacoustic therapy, laser motion guidance and a selected physical therapy program

Group Type: EXPERIMENTAL

vibro-acoustic therapy

Intervention Type: 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

Intervention Type: 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

Intervention Type: OTHER

1. Passive Prolonged Stretching and positioning

2. Range of motion exercises for both upeer limb and lower limb

3. Balance exercises static and dynamic

Group (IV)

the selected physical therapy program

Group Type: EXPERIMENTAL

selected physical therapy exercises program

Intervention Type: OTHER

1. Passive Prolonged Stretching and positioning

2. Range of motion exercises for both upeer limb and lower limb

3. Balance exercises static and dynamic

Interventions

vibro-acoustic therapy

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

Intervention Type: DEVICE

Motion Guidance Laser

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

Intervention Type: DEVICE

selected physical therapy exercises program

1. Passive Prolonged Stretching and positioning

2. Range of motion exercises for both upeer limb and lower limb

3. Balance exercises static and dynamic

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

October 6 University

OTHER

Sponsor Role: lead

Responsible Party

Lama Saad El-Din Mahmoud

Assistant Professor of Neurology and Neurosurgery Faculty of Physical Therapy October 6 University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Lama Saad El-Din ED Mahmoud

Role: CONTACT

lamaelsedawyy@hotmail.com

01157592636

Other Identifiers

P.T.REC/012/0

Identifier Type: -

Identifier Source: org_study_id