Clinical trial NCT06272838: Biodex Balance System in Patients With Parkinson's Disease
Official title: The Effectiveness of the Exercise Program Applied With the Biodex Balance System in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease
Balance training
Rehabilitation
Lead sponsor: Kirsehir Ahi Evran Universitesi
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Berg Balance Scale
timeFrame: Baseline
measure: Berg Balance Scale
timeFrame: 4th week
measure: Berg Balance Scale
timeFrame: 8 th week
measure: Biodex dynamic balance score
timeFrame: Baseline
measure: Biodex dynamic balance score
timeFrame: 4th week
measure: Biodex dynamic balance score
timeFrame: 8th week
measure: The fall efficacy scale
timeFrame: Baseline
measure: The fall efficacy scale
timeFrame: 4th week
measure: The fall efficacy scale
timeFrame: 8th week
measure: Time up and go test
timeFrame: Baseline
measure: Time up and go test
timeFrame: 4th week
measure: Time up and go test
timeFrame: 8th week
Secondary outcomes:
measure: The 8-item version of the Parkinson's Disease Questionnaire (PDQ-8)
timeFrame: Baseline
measure: The 8-item version of the Parkinson's Disease Questionnaire (PDQ-8)
timeFrame: 4th week
measure: The 8-item version of the Parkinson's Disease Questionnaire (PDQ-8)
timeFrame: 8th week
measure: The Five Times Sit to Stand Test
timeFrame: 8th week
measure: The Five Times Sit to Stand Test
timeFrame: 4th week
measure: The Five Times Sit to Stand Test
timeFrame: baseline
measure: Beck Depression Inventory
timeFrame: baseline
measure: Beck Depression Inventory
timeFrame: 4th week
measure: Beck Depression Inventory
timeFrame: 8th week
Other outcomes:
Locations:
city: Kırşehir
country: Turkey
facility: Kırşehir Ahi Evran University Faculty of Medicine
state: City Center
Study officials:
affiliation: Kirsehir Ahi Evran University
name: Basak Cigdem Karacay, Asst Prof
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.