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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06272838
Enrollment
60
Registered
2024-02-22
Start date
2024-02-28
Completion date
2024-10-14
Last updated
2024-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

Parkinson Disease, Balance training, Rehabilitation

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.

Interventions

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.

OTHERThe 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.

Sponsors

Kirsehir Ahi Evran Universitesi
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

Investigator and Outcomes Assessor will be different persons

Intervention model description

Randomised controlled

Eligibility

Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Berg Balance ScaleBaselineBerg Balance Scale was developed to measure balance performance and is used to evaluate postural control and predict fall risk. Higher scores indicate better balance
Biodex dynamic balance scoreBaselineThe 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.
The fall efficacy scaleBaselineThe 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.
Time up and go testBaselineTime 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.)

Secondary

MeasureTime frameDescription
The Five Times Sit to Stand Test8th weekThe 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.
Beck Depression InventorybaselineBeck depression inventory can be self-scored. It consists of 21 questions. Higher scores indicate increased depression.
The 8-item version of the Parkinson's Disease Questionnaire (PDQ-8)BaselineThe 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactBasak Cigdem Karacay, Asst Prof
basakcigdem@hotmail.com+9 0386 280 51 00.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026