Gait, Physical Activity, and Sleep in Parkinson's Disease
ConditionParkinson Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-75
SponsorBiruni University
About this trial
This study aims to investigate the relationship between balance and gait impairments, physical activity levels, and sleep status in individuals with Parkinson's disease (PD). Both motor and non-motor symptoms of PD significantly affect quality of life, yet these dimensions are often evaluated separately. By examining gait, balance, physical activity, and sleep parameters together and comparing patients with healthy individuals of similar age, the study seeks to clarify how these variables interact and whether observed impairments are disease-specific or related to natural aging. The findings are expected to contribute to a more comprehensive understanding of PD and support the development of more effective management strategies.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Adults aged 45-70 years will be recruited from the Department of Physical Therapy and Rehabilitation at Biruni University Hospital and from Biruni University. The study population will consist of two groups: individuals diagnosed with Parkinson's disease at Hoehn and Yahr stages 1-3 and age-matched healthy individuals without neurological or neurodegenerative disorders. All participants must be able to walk independently without assistive devices and use a smartphone for wearable device synchronization. Individuals with severe visual or hearing impairments, additional neurological disorders, significant cardiovascular or orthopedic conditions affecting gait, vascular lower extremity pathologies, or less than five years of education will be excluded
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
34 Participants
are grouped into 2 trial groupsGroup A: Healthy Volunteers
Group B: People with Parkinson's Disease
Trial outcomes
Primary outcomes
1
Mini Balance Evaluation Systems Test (Mini-BESTest) Score
Dynamic balance performance assessed using the Mini Balance Evaluation Systems Test (Mini-BESTest). The Mini-BESTest is a 14-item clinical balance assessment tool with scores ranging from 0 to 28, where higher scores indicate better balance performance. The test evaluates anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait.
Time frame
Baseline (single assessment during study participation)Secondary outcomes
1
Kinovea-Based Gait Parameters (Step Length and Stride Length)
Gait performance assessed from a 3-meter walk recorded in the sagittal plane and analyzed using Kinovea software. Step length and stride length will be calculated using heel markers (right/left) placed on participants and tracked on video
Time frame
Baseline (single assessment during study participation)2
2-Minute Walk Test (2MWT) Distance
Functional exercise capacity assessed using the 2-Minute Walk Test. Participants will walk for 2 minutes along a 30-meter walkway after a 30-minute rest period. Total distance walked will be recorded in meters. Heart rate and oxygen saturation will be monitored pre- and post-test using a pulse oximeter.
Time frame
Baseline (single assessment during study participation)3
Daily Step Count (Wearable-Recorded Physical Activity)
Physical activity level measured as daily step count using a wearable smart band (Honor Choice Band). Participants will wear the device for 7 consecutive days during normal daily activities; step counts will be extracted via the Wear Sync application.
Time frame
7 days (during one-week monitoring period)4
Pittsburgh Sleep Quality Index (PSQI) Total Score
Subjective sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI), a 19-item questionnaire evaluating sleep quality over the previous month. Higher total scores indicate poorer sleep quality.
Time frame
Baseline (single assessment during study participation)Sponsors and contacts
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Source ClinicalTrials.gov