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Gait, Physical Activity, and Sleep in Parkinson's Disease

The Relationship Between Balance and Gait Impairments, Physical Activity Level, and Sleep Quality in Parkinson's Disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07424924
Enrollment
34
Registered
2026-02-20
Start date
2026-01-05
Completion date
2026-05-20
Last updated
2026-02-20

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

Conditions

Parkinson Disease

Keywords

gain, functionality, quality of life

Brief summary

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.

Detailed description

This study will be conducted between January 2026 and May 2026 and will include 34 participants aged 45-70 years: 17 individuals diagnosed with Parkinson's disease and 17 age-matched healthy individuals without neurodegenerative disease. Participants will be recruited from Biruni University Hospital and Biruni University. Gait analysis will be performed using Kinovea software by recording a 3-meter walk in the sagittal plane, allowing evaluation of parameters such as step length and arm swing. Physical activity will be assessed using a 2-Minute Walk Test monitored with a pulse oximeter to measure oxygen saturation and functional exercise capacity, as well as daily step counts recorded over one week using a wearable smart band (Honor Choice Band). Balance will be evaluated using the Mini-BESTest. Sleep status will be assessed objectively through the smart band, which records deep sleep, light sleep, REM sleep, and wakefulness, and subjectively using the Pittsburgh Sleep Quality Index. Participants will install the Wear Sync application on their smartphones to enable synchronization and collection of wearable device data.

Interventions

None listed

Sponsors

Biruni University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

For Patients with Parkinson's Disease: A confirmed diagnosis of Parkinson's disease according to the United Kingdom (UK) Brain Bank Criteria and classified as Hoehn and Yahr stages 1-3 Ability to walk independently on a flat surface without assistive devices (Functional Ambulation Scale ≥3) Stable medication regimen during the past month Being in the "on" phase of medication For Healthy Individuals: No diagnosis of neurological and/or neurodegenerative disease

Exclusion criteria

(For both Parkinson's patients and healthy individuals) Severe hearing or visual impairments Presence of other neurological, cardiovascular, or orthopedic conditions that may affect walking ability Any additional neurological disorder (e.g., dementia, cerebrovascular disease) Education level less than 5 years Vascular pathologies affecting the lower extremities Lack of smartphone use

Design outcomes

Primary

MeasureTime frameDescription
Mini Balance Evaluation Systems Test (Mini-BESTest) ScoreBaseline (single assessment during study participation)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.

Secondary

MeasureTime frameDescription
Kinovea-Based Gait Parameters (Step Length and Stride Length)Baseline (single assessment during study participation)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
2-Minute Walk Test (2MWT) DistanceBaseline (single assessment during study participation)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.
Daily Step Count (Wearable-Recorded Physical Activity)7 days (during one-week monitoring period)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.
Pittsburgh Sleep Quality Index (PSQI) Total ScoreBaseline (single assessment during study participation)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.
Wearable-Derived Sleep Parameters (Sleep Stages and Wake Time)7 days (during one-week monitoring period)Objective sleep status measured using the Honor Choice Band, including duration of deep sleep, light sleep, REM sleep, and wake time/awake episodes as recorded automatically by the device and synchronized via the Wear Sync application.

Countries

Turkey (Türkiye)

Contacts

CONTACTGüzin Kaya Aytutuldu, phd
guzinkaya14@gmail.com05366265884

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026