NCT07206485

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 3, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

October 15, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2026

Completed
Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

September 19, 2025

Last Update Submit

March 18, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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

    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

    four weeks

Secondary Outcomes (1)

  • The Functional Independence Measure (FIM) scale

    four weeks

Study Arms (4)

Group (I)

EXPERIMENTAL

will receive vibroacoustic therapy and a selected physical therapy program.

Device: vibro-acoustic therapyOther: selected physical therapy exercises program

Group (II)

EXPERIMENTAL

laser motion guidance therapy and a selected physical therapy program

Device: Motion Guidance LaserOther: selected physical therapy exercises program

Group (III)

EXPERIMENTAL

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

Device: vibro-acoustic therapyDevice: Motion Guidance LaserOther: selected physical therapy exercises program

Group (IV)

EXPERIMENTAL

the selected physical therapy program

Other: selected physical therapy exercises program

Interventions

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

Group (I)Group (III)

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

Group (II)Group (III)

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 (I)Group (II)Group (III)Group (IV)

Eligibility Criteria

Age45 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lama Saad El-Din Mahmoud

Al Jīzah, Select State, 0020, Egypt

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Neurology and Neurosurgery Faculty of Physical Therapy October 6 University

Study Record Dates

First Submitted

September 19, 2025

First Posted

October 3, 2025

Study Start

October 15, 2025

Primary Completion

December 30, 2025

Study Completion

February 15, 2026

Last Updated

March 23, 2026

Record last verified: 2026-03

Locations