Biodex Balance System in Patients With Parkinson's Disease

NCT ID: NCT06272838

Last Updated: 2024-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-28

Study Completion Date

2024-10-14

Brief Summary

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

Detailed Description

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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.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised controlled
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Investigator and Outcomes Assessor will be different persons

Study Groups

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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..

Group Type EXPERIMENTAL

Biodex balance system

Intervention Type 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.

The conventional balance exercise program

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

The conventional balance exercise program

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kirsehir Ahi Evran Universitesi

OTHER

Sponsor Role lead

Responsible Party

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Basak Cigdem Karacay

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Basak Cigdem Karacay, Asst Prof

Role: PRINCIPAL_INVESTIGATOR

Kirsehir Ahi Evran University

Locations

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Kırşehir Ahi Evran University Faculty of Medicine

Kırşehir, City Center, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Basak Cigdem Karacay, Asst Prof

Role: CONTACT

+9 0386 280 51 00.

Facility Contacts

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Basak Cigdem Karacay, Asist Prof

Role: primary

0905445094803

References

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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.

Reference Type BACKGROUND
PMID: 34930080 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31278834 (View on PubMed)

Other Identifiers

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2023-19/145

Identifier Type: -

Identifier Source: org_study_id

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