Assessment of Methods Used in Evaluating Balance Rehabilitation in Parkinson's Patients

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-80
SponsorSultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

About this trial

Balance rehabilitation holds an important place in the treatment of Parkinson's patients. Before and after treatment, patients are evaluated using various measurement methods. In calculations of changes post-treatment, although statistically significant changes are detected, clinical differences are often not observed. Jaeschke et al. developed the concept of minimal clinically important difference (MCID) to address this. They have worked on methods to determine the level of MCID. These measurements help clinicians understand which results can be interpreted as clinically meaningful for the patient.

Responsiveness refers to how sensitive a measurement tool is to changes, whereas MCID focuses on determining whether these changes are clinically significant. Both concepts are crucial for understanding and interpreting the performance of measurement tools.

Identifying which patients have a high risk of balance problems and falls, and screening those at risk, is important for making treatment decisions. Determining which change values are clinically significant (MCID) and identifying which tests are more sensitive in detecting changes (responsiveness) are essential in monitoring patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of Parkinson's disease

Aged between 50-80 years

Modified Hoehn and Yahr stage 1.5 - 3

On stable medical treatment for the last 3 months

Disqualifiers

Age below 50 or above 80 years

Musculoskeletal disorders, severe osteoarthritis, peripheral neuropathy, or history of -previous lower extremity joint replacement

Cardiovascular disease, especially uncontrolled hypertension exceeding 180/110 mm Hg at rest within the last four weeks, or recent myocardial infarction

Orthostatic hypotension

Trial population

Your study plans to include patients who meet the inclusion criteria and voluntarily participate in the research. These patients will be recruited from the Parkinson's Disease specialized outpatient clinic of the Department of Physical Medicine and Rehabilitation at Sultan Abdulhamid Han Training and Research Hospital, Health Sciences University, starting from August 1, 2024. They will have been prescribed conventional therapy for balance improvement, robot-assisted walking therapy, or a home exercise program by a specialist physician.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Biodex

Determination of the minimal clinical important change values of balance scores (fall risk test) determined by the Biodex balance system in Parkinson's disease

Time frame
One Month

Secondary outcomes

1

International Fall Activity Scale

Determination of the minimal clinical important change values of tests assessing falls

Time frame
One Month
2

timed up and go test

Determination of the minimal clinical important change values of functional balance assessment tests

Time frame
One Month

Other outcomes

Sponsors and contacts

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