Parkinson DiseaseNCT06272838
Biodex Balance System in Patients With Parkinson's Disease
A study testing Biodex balance system and The conventional balance exercise program in people with Parkinson Disease, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Conventional balance exercises are an effective rehabilitation method applied in routine rehabilitation programs for Parkinson's patients. With technological developments, balance exercises Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Biodex balance system and The conventional balance exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Feb 2024to 14 Oct 2024
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson's diagnosis and Hoehn Yahr stage I-III
- Not changing medical treatment in the last three months
- Mini mental test score is over twenty-four
Who cannot join
- Vestibular hypofunction
- Neurological disease other than Parkinson's disease (multiple sclerosis, stroke, myopathy)
- History of lower extremity surgery (such as arthroplasty, anterior cruciate ligament repair)
- Upper limb amputation in the participant
- Impairment in cognitive functions
- History of psychotic illness
- Presence of stage 4 gonarthrosis history of malignancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kırşehir Ahi Evran University Faculty of Medicine
Kırşehir, City Center, 40100
Basak Cigdem Karacay, Asist Prof, 0905445094803, basak.cigdemkaracay@ahievran.edu.tr
Basak Cigdem Karacay, Asist Prof
About this study
Official title: The Effectiveness of the Exercise Program Applied With the Biodex Balance System in Patients With Parkinson's Disease
Conventional balance exercises are an effective rehabilitation method applied in routine rehabilitation programs for Parkinson's patients. With technological developments, balance exercises
Read the detailed description
This study was planned based on the hypothesis that exercises based on visual feedback applied to patients through games will increase patient compliance and improve balance better than conventional exercise.Previous studies have shown that the Biodex balance device has positive contributions to balance in neurological and orthopedic rehabilitation applications.
- Conditions
- Parkinson Disease
- Being tested
- Biodex balance system, The conventional balance exercise program
- Keywords
- Parkinson Disease, Balance training, Rehabilitation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biodex balance systemOther
In addition to the conventional exercise program, it will be applied on a platform with the Biodex balance system for 4 weeks, 5 days a week, in a total of 20 sessions.
The conventional balance exercise programOther
The conventional balance exercise program will be applied by a physiotherapist for 4 weeks, 5 days a week, in a total of 20 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | In addition to conventional balance exercises, the exercise program, which includes games to improve balance, performed with the help of a Biodex balance device, will be given in a total of 20 sessions, 5 days a week, for 4 weeks.. Receives: Other: Biodex balance system; Other: The conventional balance exercise program |
| Control Group | Active comparator | The conventional balance exercise program will be applied by a physiotherapist for 4 weeks, 5 days a week, in a total of 20 sessions. Receives: Other: The conventional balance exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
Berg Balance Scale was developed to measure balance performance and is used to evaluate postural control and predict fall risk. Higher scores indicate better balance
Measured: Baseline
Berg Balance Scale
Berg Balance Scale was developed to measure balance performance and is used to evaluate postural control and predict fall risk. Higher scores indicate better balance
Measured: 4th week
Berg Balance Scale
Berg Balance Scale was developed to measure balance performance and is used to evaluate postural control and predict fall risk. Higher scores indicate better balance
Measured: 8 th week
Biodex dynamic balance score
The balance assessment of the participants will be made with the Biodex Balance Systems device. During the measurement, patients will try to stay balanced on the device whose platform stability is adjusted.
Measured: Baseline
Biodex dynamic balance score
The balance assessment of the participants will be made with the Biodex Balance Systems device. During the measurement, patients will try to stay balanced on the device whose platform stability is adjusted.
Measured: 4th week
Biodex dynamic balance score
The balance assessment of the participants will be made with the Biodex Balance Systems device. During the measurement, patients will try to stay balanced on the device whose platform stability is adjusted.
Measured: 8th week
The fall efficacy scale
The fall efficacy scale consists of 10 questions rated on a 10-point Likert scale. Getting more than 70 points from the scale indicates fear of falling.
Measured: Baseline
The fall efficacy scale
The fall efficacy scale consists of 10 questions rated on a 10-point Likert scale. Getting more than 70 points from the scale indicates fear of falling.
Measured: 4th week
The fall efficacy scale
The fall efficacy scale consists of 10 questions rated on a 10-point Likert scale. Getting more than 70 points from the scale indicates fear of falling.
Measured: 8th week
Time up and go test
Time up and go testing will be performed to determine fall risk and measure balance, sit-to-stand and walking progress. Minimal detectable change in Parkinson's patients. It is 3.5 seconds. (10.2522/ptj.20090126.)
Measured: Baseline
Time up and go test
Time up and go testing will be performed to determine fall risk and measure balance, sit-to-stand and walking progress. Minimal detectable change in Parkinson's patients. It is 3.5 seconds. (10.2522/ptj.20090126.)
Measured: 4th week
Time up and go test
Time up and go testing will be performed to determine fall risk and measure balance, sit-to-stand and walking progress. Minimal detectable change in Parkinson's patients. It is 3.5 seconds. (10.2522/ptj.20090126.)
Measured: 8th week
Secondary outcomes (9)
The 8-item version of the Parkinson's Disease Questionnaire (PDQ-8)
The 8-item version of the Parkinson's Disease Questionnaire (PDQ-8)is a shortened version of the 39-item Parkinson's Disease Questionnaire (PDQ-39). It is a patient-reported outcome measure used to measure people's quality of life. It consists of 8 questions, each question is scored between 0-4. Higher scores indicate worse quality of life.
Measured: Baseline
The 8-item version of the Parkinson's Disease Questionnaire (PDQ-8)
The 8-item version of the Parkinson's Disease Questionnaire (PDQ-8)is a shortened version of the 39-item Parkinson's Disease Questionnaire (PDQ-39). It is a patient-reported outcome measure used to measure people's quality of life. It consists of 8 questions, each question is scored between 0-4. Higher scores indicate worse quality of life.
Measured: 4th week
The 8-item version of the Parkinson's Disease Questionnaire (PDQ-8)
The 8-item version of the Parkinson's Disease Questionnaire (PDQ-8)is a shortened version of the 39-item Parkinson's Disease Questionnaire (PDQ-39). It is a patient-reported outcome measure used to measure people's quality of life. It consists of 8 questions, each question is scored between 0-4. Higher scores indicate worse quality of life.
Measured: 8th week
The Five Times Sit to Stand Test
The Five Times Sit to Stand Test measures one aspect of transfer skill. The test provides a method to quantify functional lower extremity strength and/or identify movement strategies a patient uses to complete transitional movements. The patient is asked to stand up quickly and sit down 5 times and the time is recorded.
Measured: 8th week
The Five Times Sit to Stand Test
The Five Times Sit to Stand Test measures one aspect of transfer skill. The test provides a method to quantify functional lower extremity strength and/or identify movement strategies a patient uses to complete transitional movements. The patient is asked to stand up quickly and sit down 5 times and the time is recorded.
Measured: 4th week
The Five Times Sit to Stand Test
The Five Times Sit to Stand Test measures one aspect of transfer skill. The test provides a method to quantify functional lower extremity strength and/or identify movement strategies a patient uses to complete transitional movements. The patient is asked to stand up quickly and sit down 5 times and the time is recorded.
Measured: baseline
Beck Depression Inventory
Beck depression inventory can be self-scored. It consists of 21 questions. Higher scores indicate increased depression.
Measured: baseline
Beck Depression Inventory
Beck depression inventory can be self-scored. It consists of 21 questions. Higher scores indicate increased depression.
Measured: 4th week
Beck Depression Inventory
Beck depression inventory can be self-scored. It consists of 21 questions. Higher scores indicate increased depression.
Measured: 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start28 Feb 2024 (estimated)
- Primary completion14 Sep 2024 (estimated)
- Study completion14 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basak Cigdem Karacay, Kirsehir Ahi Evran Universitesi
- Investigators
- Basak Cigdem Karacay, Asst Prof, Principal investigator, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272838
- Sponsor's protocol ID
- 2023-19/145
- Status last verified
- Feb 2024
- First submitted
- 15 Feb 2024
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ramos GS, Silva-Batista C, Palma BP, Ugrinowitsch C, Cunha TFD. Risk of falls using the Biodex Balance System in non-faller patients with Parkinson Disease. Somatosens Mot Res. 2022 Jun-Dec;39(2-4):111-115. doi: 10.1080/08990220.2021.2018295. Epub 2021 Dec 21.
PubMed 34930080de Oliveira Lira JL, Ugrinowitsch C, Fecchio R, Coelho DB, Moreira-Neto A, Germano R, de Lima Miliatto AC, Dos Santos Vieira Yano BC, Silva-Batista C. Minimal Detectable Change for Balance Using the Biodex Balance System in Patients with Parkinson Disease. PM R. 2020 Mar;12(3):281-287. doi: 10.1002/pmrj.12216. Epub 2019 Aug 23.
PubMed 31278834
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of the Exercise Program Applied With the Biodex Balance System in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06272838
- Acronym / sponsor ID
- 2023-19/145
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, Balance training, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 28 Feb 2024 (estimated)
- Primary completion
- 14 Sep 2024 (estimated)
- Study completion
- 14 Oct 2024 (estimated)
- First posted
- 22 Feb 2024 (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.
Conventional balance exercises are an effective rehabilitation method applied in routine rehabilitation programs for Parkinson's patients. With technological developments, balance exercises
Detailed description
This study was planned based on the hypothesis that exercises based on visual feedback applied to patients through games will increase patient compliance and improve balance better than conventional exercise.Previous studies have shown that the Biodex balance device has positive contributions to balance in neurological and orthopedic rehabilitation applications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised controlled
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Biodex balance system, Other: The conventional balance exercise programIn addition to conventional balance exercises, the exercise program, which includes games to improve balance, performed with the help of a Biodex balance device, will be given in a total of 20 sessions, 5 days a week, for 4 weeks.. |
| Control Group | Active comparator | Other: The conventional balance exercise programThe conventional balance exercise program will be applied by a physiotherapist for 4 weeks, 5 days a week, in a total of 20 sessions. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Parkinson's diagnosis and Hoehn Yahr stage I-III
- Not changing medical treatment in the last three months
- Mini mental test score is over twenty-four
Key exclusion criteria (7 listed)
- Vestibular hypofunction
- Neurological disease other than Parkinson's disease (multiple sclerosis, stroke, myopathy)
- History of lower extremity surgery (such as arthroplasty, anterior cruciate ligament repair)
- Upper limb amputation in the participant
- Impairment in cognitive functions
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 |
|---|---|---|
| Biodex balance systemIn addition to the conventional exercise program, it will be applied on a platform with the Biodex balance system for 4 weeks, 5 days a week, in a total of 20 sessions. | Other | Experimental Group |
| The conventional balance exercise programThe conventional balance exercise program will be applied by a physiotherapist for 4 weeks, 5 days a week, in a total of 20 sessions. | Other | Control Group, Experimental Group |
Primary outcome
Berg Balance Scale
Time frame: Baseline
Berg Balance Scale was developed to measure balance performance and is used to evaluate postural control and predict fall risk. Higher scores indicate better balance
Berg Balance Scale
Time frame: 4th week
Berg Balance Scale was developed to measure balance performance and is used to evaluate postural control and predict fall risk. Higher scores indicate better balance
Berg Balance Scale
Time frame: 8 th week
Berg Balance Scale was developed to measure balance performance and is used to evaluate postural control and predict fall risk. Higher scores indicate better balance
Biodex dynamic balance score
Time frame: Baseline
The balance assessment of the participants will be made with the Biodex Balance Systems device. During the measurement, patients will try to stay balanced on the device whose platform stability is adjusted.
Biodex dynamic balance score
Time frame: 4th week
The balance assessment of the participants will be made with the Biodex Balance Systems device. During the measurement, patients will try to stay balanced on the device whose platform stability is adjusted.
Biodex dynamic balance score
Time frame: 8th week
The balance assessment of the participants will be made with the Biodex Balance Systems device. During the measurement, patients will try to stay balanced on the device whose platform stability is adjusted.
The fall efficacy scale
Time frame: Baseline
The fall efficacy scale consists of 10 questions rated on a 10-point Likert scale. Getting more than 70 points from the scale indicates fear of falling.
The fall efficacy scale
Time frame: 4th week
The fall efficacy scale consists of 10 questions rated on a 10-point Likert scale. Getting more than 70 points from the scale indicates fear of falling.
The fall efficacy scale
Time frame: 8th week
The fall efficacy scale consists of 10 questions rated on a 10-point Likert scale. Getting more than 70 points from the scale indicates fear of falling.
Time up and go test
Time frame: Baseline
Time up and go testing will be performed to determine fall risk and measure balance, sit-to-stand and walking progress. Minimal detectable change in Parkinson's patients. It is 3.5 seconds. (10.2522/ptj.20090126.)
Time up and go test
Time frame: 4th week
Time up and go testing will be performed to determine fall risk and measure balance, sit-to-stand and walking progress. Minimal detectable change in Parkinson's patients. It is 3.5 seconds. (10.2522/ptj.20090126.)
Time up and go test
Time frame: 8th week
Time up and go testing will be performed to determine fall risk and measure balance, sit-to-stand and walking progress. Minimal detectable change in Parkinson's patients. It is 3.5 seconds. (10.2522/ptj.20090126.)
9 secondary outcomes
The 8-item version of the Parkinson's Disease Questionnaire (PDQ-8)
Time frame: Baseline
The 8-item version of the Parkinson's Disease Questionnaire (PDQ-8)
Time frame: 4th week
The 8-item version of the Parkinson's Disease Questionnaire (PDQ-8)
Time frame: 8th week
The Five Times Sit to Stand Test
Time frame: 8th week
The Five Times Sit to Stand Test
Time frame: 4th week
The Five Times Sit to Stand Test
Time frame: baseline
Beck Depression Inventory
Time frame: baseline
Beck Depression Inventory
Time frame: 4th week
Beck Depression Inventory
Time frame: 8th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Background: PubMed 34930080Ramos GS, Silva-Batista C, Palma BP, Ugrinowitsch C, Cunha TFD. Risk of falls using the Biodex Balance System in non-faller patients with Parkinson Disease. Somatosens Mot Res. 2022 Jun-Dec;39(2-4):111-115. doi: 10.1080/08990220.2021.2018295. Epub 2021 Dec 21.
- Background: PubMed 31278834de Oliveira Lira JL, Ugrinowitsch C, Fecchio R, Coelho DB, Moreira-Neto A, Germano R, de Lima Miliatto AC, Dos Santos Vieira Yano BC, Silva-Batista C. Minimal Detectable Change for Balance Using the Biodex Balance System in Patients with Parkinson Disease. PM R. 2020 Mar;12(3):281-287. doi: 10.1002/pmrj.12216. Epub 2019 Aug 23.
- Individual participant dataSharing planned: No
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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.
Basak Cigdem Karacay, Asst Prof principal investigator
Kirsehir Ahi Evran Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biodex balance system and The conventional balance exercise program in people with Parkinson Disease, run by Kirsehir Ahi Evran Universitesi 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 7 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 22 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Basak Cigdem Karacay, Asst Prof (+9 0386 280 51 00., basakcigdem@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (time frame: Baseline). The study lists 12 primary outcomes in all. 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 NCT06272838, which also lists 2 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 22 Feb 2024.