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RecruitingNCT06272838Updated Feb 22, 2024

Biodex Balance System in Patients With Parkinson's Disease

An interventional study of Biodex balance system and The conventional balance exercise program in Parkinson Disease, sponsored by Kirsehir Ahi Evran Universitesi. Recruiting at 1 site in Turkey. Open to participants aged 40 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-02-22.

Sponsored by Kirsehir Ahi Evran Universitesi · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
40 Years to 90 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Parkinson Disease

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Keywords

  • Parkinson Disease
  • Balance training
  • Rehabilitation
03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's planned enrollment of 60 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Kirsehir Ahi Evran Universitesi is the lead sponsor of 133 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Experimental Group

    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..

    Other: Biodex balance system · Other: The conventional balance exercise program

  • Active comparator
    Control Group

    The conventional balance exercise program will be applied by a physiotherapist for 4 weeks, 5 days a week, in a total of 20 sessions.

    Other: The conventional balance exercise program

Interventions

  • OtherBiodex balance system

    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.

  • OtherThe conventional balance exercise program

    The conventional balance exercise program will be applied by a physiotherapist for 4 weeks, 5 days a week, in a total of 20 sessions.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline

  2. 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

    Time frame: 4th week

  3. 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

    Time frame: 8 th week

  4. 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.

    Time frame: Baseline

  5. 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.

    Time frame: 4th week

  6. 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.

    Time frame: 8th week

  7. 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.

    Time frame: Baseline

  8. 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.

    Time frame: 4th week

  9. 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.

    Time frame: 8th week

  10. 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.)

    Time frame: Baseline

  11. 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.)

    Time frame: 4th week

  12. 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.)

    Time frame: 8th week

Secondary outcomes

  1. 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.

    Time frame: Baseline

  2. 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.

    Time frame: 4th week

  3. 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.

    Time frame: 8th week

  4. 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.

    Time frame: 8th week

  5. 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.

    Time frame: 4th week

  6. 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.

    Time frame: baseline

  7. Beck Depression Inventory

    Beck depression inventory can be self-scored. It consists of 21 questions. Higher scores indicate increased depression.

    Time frame: baseline

  8. Beck Depression Inventory

    Beck depression inventory can be self-scored. It consists of 21 questions. Higher scores indicate increased depression.

    Time frame: 4th week

  9. Beck Depression Inventory

    Beck depression inventory can be self-scored. It consists of 21 questions. Higher scores indicate increased depression.

    Time frame: 8th week

07

Study locations

1 of 1 sites recruiting
  • Kırşehir Ahi Evran University Faculty of Medicine
    Kırşehir, City Center 40100, Turkey
    Recruiting
08

References and documents

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 34930080 ↗
  • de 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06272838
Lead sponsor
Kirsehir Ahi Evran Universitesi
Responsible party
Basak Cigdem Karacay (Principal Investigator, Kirsehir Ahi Evran Universitesi) — Principal investigator
First posted
Feb 22, 2024
Start date
Feb 28, 2024 (estimated)
Primary completion
Sep 14, 2024 (estimated)
Completion
Oct 14, 2024 (estimated)
Last update
Feb 22, 2024

Study contacts

Basak Cigdem Karacay, Asst Prof
Contact
basakcigdem@hotmail.com
+9 0386 280 51 00.
Basak Cigdem Karacay, Asst Prof
principal investigator · Kirsehir Ahi Evran University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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