Biodex Balance System in Patients With Parkinson's Disease

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

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Biodex balance system; Other: The conventional balance exercise program

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Basak Cigdem Karacay, Asst Prof; Phone Number: +9 0386 280 51 00.; Email: basakcigdem@hotmail.com

Study Locations

• Turkey
  • City Center
    • Kırşehir, City Center, Turkey, 40100
      • Recruiting
      • Kırşehir Ahi Evran University Faculty of Medicine
      • Contact: Basak Cigdem Karacay, Asist Prof; Phone Number: 0905445094803; Email: basak.cigdemkaracay@ahievran.edu.tr
      • Principal Investigator: Basak Cigdem Karacay, Asist Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.; Other: 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.
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; The conventional balance exercise program will be applied by a physiotherapist for 4 weeks, 5 days a week, in a total of 20 sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
Beck Depression Inventory	Beck depression inventory can be self-scored. It consists of 21 questions. Higher scores indicate increased depression.	baseline
Beck Depression Inventory	Beck depression inventory can be self-scored. It consists of 21 questions. Higher scores indicate increased depression.	4th week
Beck Depression Inventory	Beck depression inventory can be self-scored. It consists of 21 questions. Higher scores indicate increased depression.	8th week

Collaborators and Investigators

• Sponsor: Kirsehir Ahi Evran Universitesi
• Investigators: Principal Investigator: Basak Cigdem Karacay, Asst Prof, Kirsehir Ahi Evran University

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): February 28, 2024
• Primary Completion (Estimated): September 14, 2024
• Study Completion (Estimated): October 14, 2024

Study Registration Dates

• First Submitted: February 15, 2024
• First Submitted That Met QC Criteria: February 16, 2024
• First Posted (Actual): February 22, 2024

Study Record Updates

• Last Update Posted (Actual): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Rehabilitation; Parkinson Disease; Balance training
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 2023-19/145

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No