Biodex Balance System in Patients With Parkinson's Disease

NCT06272838 | Recruiting

• 1 other identifier: 2023-19/145
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Parkinson Disease

Keywords

Parkinson Disease; Balance training; Rehabilitation

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (9)

• The 8-item version of the Parkinson's Disease Questionnaire (PDQ-8)

  Baseline

• The 8-item version of the Parkinson's Disease Questionnaire (PDQ-8)

  4th week

• The 8-item version of the Parkinson's Disease Questionnaire (PDQ-8)

  8th week

• The Five Times Sit to Stand Test

  8th week

• The Five Times Sit to Stand Test

  4th week

Study Arms (2)

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..

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.

Other: The conventional balance exercise program

Interventions

Biodex balance system OTHER

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.

Experimental Group

The conventional balance exercise program OTHER

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

Control Group; Experimental Group

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kirsehir Ahi Evran Universitesi: lead

Study Sites (1)

Kırşehir Ahi Evran University Faculty of Medicine

Kırşehir, City Center, 40100, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• 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.

  PMID: 34930080 BACKGROUND

• 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.

  PMID: 31278834 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Basak Cigdem Karacay, Asst Prof

  Kirsehir Ahi Evran University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Basak Cigdem Karacay, Asst Prof

CONTACT

+9 0386 280 51 00.; basakcigdem@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator and Outcomes Assessor will be different persons
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomised controlled

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 22, 2024
• Study Start: February 28, 2024
• Primary Completion: September 14, 2024
• Study Completion: October 14, 2024
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)