Vestibular DisorderNCT04425928
Activity Treatment on Vestibular Rehabilitation
A study testing occupational therapy based activity training programs and Physiotherapy based exercise training programs in people with Vestibular Disorder, run by Bilgehan Tekin Dal at 1 site in Turkey (Türkiye).
Trial summary
In this study it was aimed to investigate the effects of home treatment program based standard activity on dizziness, balance and daily life activity in patients with dizziness complaint originated from chronic unilateral peripheral vestibular disorder and compare to effects of exercise-based home rehabilitation… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Vestibular Disorder
- What is being tested?
- occupational therapy based activity training programs and Physiotherapy based exercise training programs
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2018to 19 Nov 2019
- 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients have dizziness complaint longer than 3 months,
- History of at least one dizziness in a month
- Patient has been diagnosed chronic unilateral peripheric vestibular disorder
Who cannot join
- Patients with diagnosed benign paroxysmal positional vertigo, had Meniere's disease, had history of central nerve system impairments and/or psychiatric disorder, had uncontrolled hypertension and diabetes, had not understanding simple verbal instruction and following ability, not able to stand independent in the standstill position, had visual problems that cannot be treated with lenses or glasses, had movement limitation due to the orthopedic problem, using medication for dizziness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Activity-Based Home Program and Cawthorne-Cooksey Exercises in Patients With Chronic Unilateral Peripheral Vestibular Disorders
In this study it was aimed to investigate the effects of home treatment program based standard activity on dizziness, balance and daily life activity in patients with dizziness complaint originated from chronic unilateral peripheral vestibular disorder and compare to effects of exercise-based home rehabilitation program.
Read the detailed description
The aim of this study was to assess the effects of an activity training programme on dizziness, imbalance, and level of independence in daily living activities in patients with chronic dizziness. 75 patients between 18-65 years of age who diagnosed chronic peripheral vestibular disorders and individuals with vestibular rehabilitation indications were included in our study. Patients were randomly divided into 3 groups consist of 25 patients as an activity group, exercise group, and control group. Education was given to each group. İn addition, the activity group was performed a training activities program, the exercise group was performed in the Cawthorne-Cooksey exercises program. Therapy programs were prescribed once daily at home for 4 weeks. After demographic information was obtained from all patients, assessments were performed at the beginning and at the end of the treatment program (4 weeks). Dizziness severity was assessed by the Visual Analog Scale (VAS), activities of daily livings were assessed by Vestibular Disorders Activity Questionnaire (VADL) and balance was assessed by Sensory Organization Testing (SOT).
- Conditions
- Vestibular Disorder
- Being tested
- occupational therapy based activity training programs, Physiotherapy based exercise training programs
- Medical subject headings
- Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
occupational therapy based activity training programsProcedure or surgery
Also called purposeful activities
Occupational therapy based activity training programs in which exercises based on physiotherapy are put into the purposeful activities at vestibular rehabilitation.
Physiotherapy based exercise training programsProcedure or surgery
Also called Cawthorne-cooksey exercises
Cawthorne-cooksey exercises were performed at vestibular rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| activity group | Active comparator | Participants received an activity-based home program that was performed for 4 weeks. Receives: Procedure: occupational therapy based activity training programs |
| exercise group | Experimental | Participants received an exercise-based home program was performed that was performed for 4 weeks. Receives: Procedure: Physiotherapy based exercise training programs |
| control group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from before and after treatment in the severity of dizziness on Visual Analog scale (VAS).
VAS is a self-reported instrument assessing the severity of diziness.
Measured: before and after treatment (4 weeks)
Secondary outcomes (1)
Change from before and after treatment in the Independent level of activity in the daily life on Vestibular Disorders Activities of Daily Living Scale (VADL).
VADL is a questionnaire assessing the Independent level of activity in daily life.
Measured: before and after treatment (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start15 Apr 2018
- Primary completion1 Jun 2019
- Study completion19 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vestibular DisorderStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bilgehan Tekin Dal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bilgehan Tekin Dal, Gazi University
- Investigators
- Gonca Bumin, Prof, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04425928
- Sponsor's protocol ID
- 5057087198
- Status last verified
- Aug 2020
- First submitted
- 1 Jun 2020
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tekin Dal B, Bumin G, Aksoy S, Gunaydin RO. Comparison of Activity-Based Home Program and Cawthorne-Cooksey Exercises in Patients With Chronic Unilateral Peripheral Vestibular Disorders. Arch Phys Med Rehabil. 2021 Jul;102(7):1300-1307. doi: 10.1016/j.apmr.2020.12.022. Epub 2021 Jan 30.
PubMed 33529612
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Activity-Based Home Program and Cawthorne-Cooksey Exercises in Patients With Chronic Unilateral Peripheral Vestibular Disorders
- ClinicalTrials.gov ID
- NCT04425928
- Acronym / sponsor ID
- 5057087198
- Conditions
- Vestibular Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Bilgehan Tekin DalUniversity, hospital or other
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 19 Nov 2019 (actual)
- First posted
- 11 Jun 2020 (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.
In this study it was aimed to investigate the effects of home treatment program based standard activity on dizziness, balance and daily life activity in patients with dizziness complaint originated from chronic unilateral peripheral vestibular disorder and compare to effects of exercise-based home rehabilitation program.
Detailed description
The aim of this study was to assess the effects of an activity training programme on dizziness, imbalance, and level of independence in daily living activities in patients with chronic dizziness. 75 patients between 18-65 years of age who diagnosed chronic peripheral vestibular disorders and individuals with vestibular rehabilitation indications were included in our study. Patients were randomly divided into 3 groups consist of 25 patients as an activity group, exercise group, and control group. Education was given to each group. İn addition, the activity group was performed a training activities program, the exercise group was performed in the Cawthorne-Cooksey exercises program. Therapy programs were prescribed once daily at home for 4 weeks. After demographic information was obtained from all patients, assessments were performed at the beginning and at the end of the treatment program (4 weeks). Dizziness severity was assessed by the Visual Analog Scale (VAS), activities of daily livings were assessed by Vestibular Disorders Activity Questionnaire (VADL) and balance was assessed by Sensory Organization Testing (SOT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| activity group | Active comparator | Procedure: occupational therapy based activity training programsParticipants received an activity-based home program that was performed for 4 weeks. |
| exercise group | Experimental | Procedure: Physiotherapy based exercise training programsParticipants received an exercise-based home program was performed that was performed for 4 weeks. |
| control group | No intervention | –No intervention |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients have dizziness complaint longer than 3 months,
- History of at least one dizziness in a month
- Patient has been diagnosed chronic unilateral peripheric vestibular disorder
Key exclusion criteria (1 listed)
- Patients with diagnosed benign paroxysmal positional vertigo, had Meniere's disease, had history of central nerve system impairments and/or psychiatric disorder, had uncontrolled hypertension and diabetes, had not understanding simple verbal instruction and following ability, not able to stand independent in the standstill position, had visual problems that cannot be treated with lenses or glasses, had movement limitation due to the orthopedic problem, using medication for dizziness.
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 |
|---|---|---|
| occupational therapy based activity training programsAlso: purposeful activitiesOccupational therapy based activity training programs in which exercises based on physiotherapy are put into the purposeful activities at vestibular rehabilitation. | Procedure or surgery | activity group |
| Physiotherapy based exercise training programsAlso: Cawthorne-cooksey exercisesCawthorne-cooksey exercises were performed at vestibular rehabilitation | Procedure or surgery | exercise group |
Primary outcome
Change from before and after treatment in the severity of dizziness on Visual Analog scale (VAS).
Time frame: before and after treatment (4 weeks)
VAS is a self-reported instrument assessing the severity of diziness.
1 secondary outcome
Change from before and after treatment in the Independent level of activity in the daily life on Vestibular Disorders Activities of Daily Living Scale (VADL).
Time frame: before and after treatment (4 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 11 Aug 2020.
- Derived from this study: PubMed 33529612Tekin Dal B, Bumin G, Aksoy S, Gunaydin RO. Comparison of Activity-Based Home Program and Cawthorne-Cooksey Exercises in Patients With Chronic Unilateral Peripheral Vestibular Disorders. Arch Phys Med Rehabil. 2021 Jul;102(7):1300-1307. doi: 10.1016/j.apmr.2020.12.022. Epub 2021 Jan 30.
- Individual participant dataSharing planned: No
Related trials for Vestibular Disorder
RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Comparison of Vestibular Stimulation and Core Stability Training on Sitting Balance in Hypotonic CP
Hypotonic Cerebral Palsy
Enrolling by invitationObservational study
Long Term Follow-up Study of AAVAnc80-antiVEGF Gene Therapy
Vestibular Schwannoma
RecruitingPhase 1/2
Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma
Vestibular Schwannoma
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.
Gonca Bumin, Prof study director
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing occupational therapy based activity training programs and Physiotherapy based exercise training programs in people with Vestibular Disorder, run by Bilgehan Tekin Dal at 1 site in Turkey (Türkiye).
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 3 inclusion and 1 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 11 Aug 2020. 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 Turkey (Türkiye). 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?
Change from before and after treatment in the severity of dizziness on Visual Analog scale (VAS). (time frame: before and after treatment (4 weeks)). 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 NCT04425928, which also lists 1 linked publication.
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 11 Aug 2020.