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

NCT07424924 | Recruiting

• 1 other identifier: BiruniUniv.
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

gain, functionality, quality of life

Outcome Measures

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.

  Baseline (single assessment during study participation)

Secondary Outcomes (5)

• Kinovea-Based Gait Parameters (Step Length and Stride Length)

  Baseline (single assessment during study participation)

• 2-Minute Walk Test (2MWT) Distance

  Baseline (single assessment during study participation)

• Daily Step Count (Wearable-Recorded Physical Activity)

  7 days (during one-week monitoring period)

• Pittsburgh Sleep Quality Index (PSQI) Total Score

  Baseline (single assessment during study participation)

• Wearable-Derived Sleep Parameters (Sleep Stages and Wake Time)

  7 days (during one-week monitoring period)

Study Arms (2)

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.

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• (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

Sponsors & Collaborators

• Biruni University: lead

Study Sites (1)

Biruni University Hospital

Istanbul, 34010, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Bene R, Antic S, Budisic M, Lisak M, Trkanjec Z, Demarin V, Podobnik-Sarkanji S. Parkinson's disease. Acta Clin Croat. 2009 Sep;48(3):377-80.

  PMID: 20055267 BACKGROUND

• Jankovic J. Parkinson's disease: clinical features and diagnosis. J Neurol Neurosurg Psychiatry. 2008 Apr;79(4):368-76. doi: 10.1136/jnnp.2007.131045.

  PMID: 18344392 BACKGROUND

• Kalia LV, Lang AE. Parkinson's disease. Lancet. 2015 Aug 29;386(9996):896-912. doi: 10.1016/S0140-6736(14)61393-3. Epub 2015 Apr 19.

  PMID: 25904081 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Güzin Kaya Aytutuldu, phd

CONTACT

05366265884; guzinkaya14@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: February 20, 2026
• Study Start: January 5, 2026
• Primary Completion: March 5, 2026
• Study Completion: May 20, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)