NCT05543473

Brief 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 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 .

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

September 16, 2022

Status Verified

September 1, 2022

Enrollment Period

1 year

First QC Date

September 13, 2022

Last Update Submit

September 15, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percentage of change in balance function

    The computerized dynamic posturography sensory organization test (CDP-SOT)

    3 months after the end of Vestibular rehabilitation therapy

Study Arms (1)

patients

EXPERIMENTAL

patients with brain radiological findings that affect balance functions

Other: Vestibular Rehabilitation Therapy

Interventions

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

patients

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Geriatric population , above age 60 years old.
  • Patients with orthopedic problems , neurological or cardiovascular diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University hospital

Sohag, Egypt

RECRUITING

Related Publications (4)

  • 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.

    PMID: 26412160BACKGROUND
  • Alcock 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.

    PMID: 30395787BACKGROUND
  • Alyono 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.

    PMID: 29803531BACKGROUND
  • Ekvall 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.

    PMID: 33005434BACKGROUND

Central Study Contacts

Marwa N Fahmy, residant

CONTACT

Mohamed A Abdelrahman, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor at audio-vestibular medicine unit sohag university

Study Record Dates

First Submitted

September 13, 2022

First Posted

September 16, 2022

Study Start

September 1, 2022

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

September 16, 2022

Record last verified: 2022-09

Locations