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

February 16, 2026 updated by: Guzin Kaya Aytutuldu, Biruni University

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34010
        • Recruiting
        • Biruni University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study 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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Healthy Volunteers
Age-matched healthy individuals (45-70 years) without neurological or chronic diseases. Participants will undergo gait analysis (Kinovea), Mini-BESTest for balance assessment, 2-Minute Walk Test with pulse oximeter monitoring, one-week physical activity monitoring via wearable device (Honor Choice Band), and sleep evaluation using wearable-recorded sleep parameters and the Pittsburgh Sleep Quality Index.
People with Parkinson's Disease
Individuals aged 45-70 years diagnosed with Parkinson's disease. Participants will undergo gait analysis (Kinovea), Mini-BESTest for balance assessment, 2-Minute Walk Test with pulse oximeter monitoring, one-week physical activity monitoring via wearable device (Honor Choice Band), and sleep evaluation using wearable-recorded sleep parameters and the Pittsburgh Sleep Quality Index.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mini Balance Evaluation Systems Test (Mini-BESTest) Score
Time Frame: Baseline (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.
Baseline (single assessment during study participation)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kinovea-Based Gait Parameters (Step Length and Stride Length)
Time Frame: 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
Baseline (single assessment during study participation)
2-Minute Walk Test (2MWT) Distance
Time Frame: Baseline (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.
Baseline (single assessment during study participation)
Daily Step Count (Wearable-Recorded Physical Activity)
Time Frame: 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.
7 days (during one-week monitoring period)
Pittsburgh Sleep Quality Index (PSQI) Total Score
Time Frame: Baseline (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.
Baseline (single assessment during study participation)
Wearable-Derived Sleep Parameters (Sleep Stages and Wake Time)
Time Frame: 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.
7 days (during one-week monitoring period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biruni University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2026

Primary Completion (Estimated)

March 5, 2026

Study Completion (Estimated)

May 20, 2026

Study Registration Dates

First Submitted

February 16, 2026

First Submitted That Met QC Criteria

February 16, 2026

First Posted (Actual)

February 20, 2026

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 16, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BiruniUniv.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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