Brain Vascular InsultNCT05543473
Effect of Vestibular Rehabilitation Therapy on Patients With Brain Radiological Findings That Affect Balance Functions
A study testing Vestibular Rehabilitation Therapy in people with Brain Vascular Insult, run by Sohag University at 1 site in Egypt.
Trial summary
Occurrence of cerebrovascular diseases, particularly of cerebral small vessel disease (SVD), appears to play some role in the development of gait and balance impairment . Beside small vessel disease , stroke is one of the most common cause of long-term adult disability leading to cognitive and motor function… Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Brain Vascular Insult
- What is being tested?
- Vestibular Rehabilitation Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2022to Sep 2023
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: from 40 years to 60 years old.
- Sex: males and females.
- Can withstand and willing to undergo repeated CDP trials.
- No evidence of orthopedic problems, neurological or cardiovascular diseases. - No history of any disease required to give treatment that could affect results.
Who cannot join
- Geriatric population , above age 60 years old.
- Patients with orthopedic problems , neurological or cardiovascular diseases.
Trial locations and contacts
1 site in 1 country.
Mohamed A Abdelrahman, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University hospital
Sohag
Magdy M Amin, Professor
About this study
Occurrence of cerebrovascular diseases, particularly of cerebral small vessel disease (SVD), appears to play some role in the development of gait and balance impairment . Beside small vessel disease , stroke is one of the most common cause of long-term adult disability leading to cognitive and motor function impairments. Particularly, gait and balance disorders that may contribute to immobility and falls.
The design of personalized rehabilitation protocols, focused on the recovery of dynamic balance ability would be fundamental to reduce these deficits and consequently, the risk of falling, thus improving patients' quality of life. Vestibular rehabilitation therapy (VRT) is an exercise-based treatment program designed to promote vestibular adaptation and substitution. The goals of VRT are to enhance gaze stability, to enhance postural stability, to improve vertigo, and to improve activities of daily living. VRT facilitates vestibular recovery mechanisms: vestibular adaptation, substitution by the other eye-movement systems, substitution by vision, somatosensory cues, other postural strategies, and habituation .
- Conditions
- Brain Vascular Insult
- Being tested
- Vestibular Rehabilitation Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular Rehabilitation TherapyOther
an exercise-based treatment program designed to promote vestibular adaptation and substitution. The goals of VRT are to enhance gaze stability, to enhance postural stability, to improve vertigo, and to improve activities of daily living. VRT facilitates vestibular recovery mechanisms: vestibular adaptation, substitution by the other eye-movement systems, substitution by vision, somatosensory cues, other postural strategies, and habituation
| Study group | Role | What they receive |
|---|---|---|
| patients | Experimental | patients with brain radiological findings that affect balance functions Receives: Other: Vestibular Rehabilitation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of change in balance function
The computerized dynamic posturography sensory organization test (CDP-SOT)
Measured: 3 months after the end of Vestibular rehabilitation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start1 Sep 2022
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Brain Vascular InsultStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Nasser Fahmy, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543473
- Sponsor's protocol ID
- Soh-Med-22-07-13
- Status last verified
- Sep 2022
- First submitted
- 13 Sep 2022
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ahmad H, Cerchiai N, Mancuso M, Casani AP, Bronstein AM. Are white matter abnormalities associated with "unexplained dizziness"? J Neurol Sci. 2015 Nov 15;358(1-2):428-31. doi: 10.1016/j.jns.2015.09.006. Epub 2015 Sep 4.
PubMed 26412160Alcock L, O'Brien TD, Vanicek N. Association between somatosensory, visual and vestibular contributions to postural control, reactive balance capacity and healthy ageing in older women. Health Care Women Int. 2018 Dec;39(12):1366-1380. doi: 10.1080/07399332.2018.1499106. Epub 2018 Nov 5.
PubMed 30395787Alyono JC. Vertigo and Dizziness: Understanding and Managing Fall Risk. Otolaryngol Clin North Am. 2018 Aug;51(4):725-740. doi: 10.1016/j.otc.2018.03.003. Epub 2018 May 24.
PubMed 29803531Ekvall Hansson E, Pessah-Rasmussen H, Bring A, Vahlberg B, Persson L. Vestibular rehabilitation for persons with stroke and concomitant dizziness-a pilot study. Pilot Feasibility Stud. 2020 Sep 30;6:146. doi: 10.1186/s40814-020-00690-2. eCollection 2020.
PubMed 33005434
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vestibular Rehabilitation Therapy on Patients With Brain Radiological Findings That Affect Balance Functions
- ClinicalTrials.gov ID
- NCT05543473
- Acronym / sponsor ID
- Soh-Med-22-07-13
- Conditions
- Brain Vascular Insult
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 16 Sep 2022 (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.
Occurrence of cerebrovascular diseases, particularly of cerebral small vessel disease (SVD), appears to play some role in the development of gait and balance impairment . Beside small vessel disease , stroke is one of the most common cause of long-term adult disability leading to cognitive and motor function impairments. Particularly, gait and balance disorders that may contribute to immobility and falls.
The design of personalized rehabilitation protocols, focused on the recovery of dynamic balance ability would be fundamental to reduce these deficits and consequently, the risk of falling, thus improving patients' quality of life. Vestibular rehabilitation therapy (VRT) is an exercise-based treatment program designed to promote vestibular adaptation and substitution. The goals of VRT are to enhance gaze stability, to enhance postural stability, to improve vertigo, and to improve activities of daily living. VRT facilitates vestibular recovery mechanisms: vestibular adaptation, substitution by the other eye-movement systems, substitution by vision, somatosensory cues, other postural strategies, and habituation .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | Experimental | Other: Vestibular Rehabilitation Therapypatients with brain radiological findings that affect balance functions |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: from 40 years to 60 years old.
- Sex: males and females.
- Can withstand and willing to undergo repeated CDP trials.
- No evidence of orthopedic problems, neurological or cardiovascular diseases. - No history of any disease required to give treatment that could affect results.
Key exclusion criteria (2 listed)
- Geriatric population , above age 60 years old.
- Patients with orthopedic problems , neurological or cardiovascular diseases.
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 |
|---|---|---|
| Vestibular Rehabilitation Therapyan exercise-based treatment program designed to promote vestibular adaptation and substitution. The goals of VRT are to enhance gaze stability, to enhance postural stability, to improve vertigo, and to improve activities of daily living. VRT facilitates vestibular recovery mechanisms: vestibular adaptation, substitution by the other eye-movement systems, substitution by vision, somatosensory cues, other postural strategies, and habituation | Other | patients |
Primary outcome
Percentage of change in balance function
Time frame: 3 months after the end of Vestibular rehabilitation therapy
The computerized dynamic posturography sensory organization test (CDP-SOT)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
- Background: PubMed 26412160Ahmad H, Cerchiai N, Mancuso M, Casani AP, Bronstein AM. Are white matter abnormalities associated with "unexplained dizziness"? J Neurol Sci. 2015 Nov 15;358(1-2):428-31. doi: 10.1016/j.jns.2015.09.006. Epub 2015 Sep 4.
- Background: PubMed 30395787Alcock L, O'Brien TD, Vanicek N. Association between somatosensory, visual and vestibular contributions to postural control, reactive balance capacity and healthy ageing in older women. Health Care Women Int. 2018 Dec;39(12):1366-1380. doi: 10.1080/07399332.2018.1499106. Epub 2018 Nov 5.
- Background: PubMed 29803531Alyono JC. Vertigo and Dizziness: Understanding and Managing Fall Risk. Otolaryngol Clin North Am. 2018 Aug;51(4):725-740. doi: 10.1016/j.otc.2018.03.003. Epub 2018 May 24.
- Background: PubMed 33005434Ekvall Hansson E, Pessah-Rasmussen H, Bring A, Vahlberg B, Persson L. Vestibular rehabilitation for persons with stroke and concomitant dizziness-a pilot study. Pilot Feasibility Stud. 2020 Sep 30;6:146. doi: 10.1186/s40814-020-00690-2. eCollection 2020.
- Individual participant dataSharing planned: Undecided
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.
Mohamed A Abdelrahman, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular Rehabilitation Therapy in people with Brain Vascular Insult, run by Sohag 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 2 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: status not confirmed, as of the sponsor's last update on 16 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marwa N Fahmy, residant (01018371517, marwanasser@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of change in balance function (time frame: 3 months after the end of Vestibular rehabilitation therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05543473, which also lists 4 linked publications.
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 16 Sep 2022.