StrokeNCT07206485
Vibroacoustic Therap in Patients With Stroke
A study testing vibro-acoustic therapy, Motion Guidance Laser and selected physical therapy exercises program in people with Stroke, run by October 6 University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Stroke
- What is being tested?
- vibro-acoustic therapy, Motion Guidance Laser and selected physical therapy exercises program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2025to 15 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Vibroacoustic Therapy Device With Laser Motion Guidance on Balance Sensory Integration 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.
Read the 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
- Being tested
- vibro-acoustic therapy, Motion Guidance Laser, selected physical therapy exercises program
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vibro-acoustic therapyDevice
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 LaserDevice
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 programOther
- Passive Prolonged Stretching and positioning
- Range of motion exercises for both upeer limb and lower limb
- Balance exercises static and dynamic
| Study group | Role | What they receive |
|---|---|---|
| Group (I) | Experimental | will receive vibroacoustic therapy and a selected physical therapy program. Receives: Device: vibro-acoustic therapy; Other: selected physical therapy exercises program |
| Group (II) | Experimental | laser motion guidance therapy and a selected physical therapy program Receives: Device: Motion Guidance Laser; Other: selected physical therapy exercises program |
| Group (III) | Experimental | vibroacoustic therapy, laser motion guidance and a selected physical therapy program Receives: Device: vibro-acoustic therapy; Device: Motion Guidance Laser; Other: selected physical therapy exercises program |
| Group (IV) | Experimental | the selected physical therapy program Receives: Other: selected physical therapy exercises program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biodex balance system
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.
Measured: four weeks
Time up and go test (TUG)
The TUG is a general physical performance test used to assess mobility, balance, and locomotor performance in elderly people
Measured: four weeks
Biodex balance system Overall Stability Index (OSI)
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
Measured: four weeks
Secondary outcomes (1)
The Functional Independence Measure (FIM) scale
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.
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start15 Oct 2025
- Primary completion30 Dec 2025
- Study completion15 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lama Saad El-Din Mahmoud, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07206485
- Sponsor's protocol ID
- P.T.REC/012/006151
- Status last verified
- Mar 2026
- First submitted
- 19 Sep 2025
- Last updated
- 23 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vibroacoustic Therapy Device With Laser Motion Guidance on Balance Sensory Integration in Patients With Stroke
- ClinicalTrials.gov ID
- NCT07206485
- Acronym / sponsor ID
- P.T.REC/012/006151
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 15 Feb 2026 (actual)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group (I) | Experimental | Device: vibro-acoustic therapy, Other: selected physical therapy exercises programwill receive vibroacoustic therapy and a selected physical therapy program. |
| Group (II) | Experimental | Device: Motion Guidance Laser, Other: selected physical therapy exercises programlaser motion guidance therapy and a selected physical therapy program |
| Group (III) | Experimental | Device: vibro-acoustic therapy, Device: Motion Guidance Laser, Other: selected physical therapy exercises programvibroacoustic therapy, laser motion guidance and a selected physical therapy program |
| Group (IV) | Experimental | Other: selected physical therapy exercises programthe selected physical therapy program |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vibro-acoustic therapyVibroacoustic 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 | Device | Group (I), Group (III) |
| Motion Guidance LaserMotion 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 | Device | Group (II), Group (III) |
| selected physical therapy exercises program1. Passive Prolonged Stretching and positioning 2. Range of motion exercises for both upeer limb and lower limb 3. Balance exercises static and dynamic | Other | Group (I), Group (II), Group (III), Group (IV) |
Primary outcome
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.
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
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
1 secondary outcome
The Functional Independence Measure (FIM) scale
Time frame: four weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vibro-acoustic therapy, Motion Guidance Laser and selected physical therapy exercises program in people with Stroke, run by October 6 University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biodex balance system (time frame: four weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.