Biodex Balance System in Patients With Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

The Effectiveness of the Exercise Program Applied With the Biodex Balance System in Patients With Parkinson's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06272838
• Other study ID #: 2023-19/145
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2024
• Est. completion date: October 14, 2024

Study information

• Verified date: February 2024
• Source: Kirsehir Ahi Evran Universitesi
• Contact: Basak Cigdem Karacay, Asst Prof
• Phone: +9 0386 280 51 00.
• Email: basakcigdem[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Conventional balance exercises are an effective rehabilitation method applied in routine rehabilitation programs for Parkinson's patients. With technological developments, balance exercises

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 14, 2024
• Est. primary completion date: September 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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:

• 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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Biodex 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.
• The 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.

Locations

Country	Name	City	State
Turkey	Kirsehir Ahi Evran University Faculty of Medicine	Kirsehir	City Center

Sponsors (1)

Lead Sponsor	Collaborator
Kirsehir Ahi Evran Universitesi

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline
Primary	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	4th week
Primary	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	8 th week
Primary	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.	Baseline
Primary	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.	4th week
Primary	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.	8th week
Primary	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.	Baseline
Primary	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.	4th week
Primary	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.	8th week
Primary	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.)	Baseline
Primary	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.)	4th week
Primary	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.)	8th week
Secondary	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.	Baseline
Secondary	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.	4th week
Secondary	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.	8th week
Secondary	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.	8th week
Secondary	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.	4th week
Secondary	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.	baseline
Secondary	Beck Depression Inventory	Beck depression inventory can be self-scored. It consists of 21 questions. Higher scores indicate increased depression.	baseline
Secondary	Beck Depression Inventory	Beck depression inventory can be self-scored. It consists of 21 questions. Higher scores indicate increased depression.	4th week
Secondary	Beck Depression Inventory	Beck depression inventory can be self-scored. It consists of 21 questions. Higher scores indicate increased depression.	8th week