Parkinson DiseaseNCT07424924
Gait, Physical Activity, and Sleep in Parkinson's Disease
An observational study of Parkinson Disease, run by Biruni University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2026to 20 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- (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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Biruni University Hospital
Istanbul, 34010
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson Disease
- Keywords
- gain, functionality, quality of life
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (single assessment during study participation)
Secondary outcomes (5)
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
Measured: Baseline (single assessment during study participation)
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.
Measured: Baseline (single assessment during study participation)
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.
Measured: 7 days (during one-week monitoring period)
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.
Measured: Baseline (single assessment during study participation)
Wearable-Derived Sleep Parameters (Sleep Stages and Wake Time)
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.
Measured: 7 days (during one-week monitoring period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start5 Jan 2026
- Primary completion5 Mar 2026 (estimated)
- Study completion20 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guzin Kaya Aytutuldu, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07424924
- Sponsor's protocol ID
- BiruniUniv.
- Status last verified
- Feb 2026
- First submitted
- 16 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20055267Jankovic J. Parkinson's disease: clinical features and diagnosis. J Neurol Neurosurg Psychiatry. 2008 Apr;79(4):368-76. doi: 10.1136/jnnp.2007.131045.
PubMed 18344392Kalia 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.
PubMed 25904081
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Balance and Gait Impairments, Physical Activity Level, and Sleep Quality in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07424924
- Acronym / sponsor ID
- BiruniUniv.
- Conditions
- Parkinson Disease
- Keywords
- gain, functionality, quality of life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 5 Mar 2026 (estimated)
- Study completion
- 20 May 2026 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 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
- No diagnosis of neurological and/or neurodegenerative disease
Key exclusion criteria (7 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Kinovea-Based Gait Parameters (Step Length and Stride Length)
Time frame: Baseline (single assessment during study participation)
2-Minute Walk Test (2MWT) Distance
Time frame: Baseline (single assessment during study participation)
Daily Step Count (Wearable-Recorded Physical Activity)
Time frame: 7 days (during one-week monitoring period)
Pittsburgh Sleep Quality Index (PSQI) Total Score
Time frame: Baseline (single assessment during study participation)
Wearable-Derived Sleep Parameters (Sleep Stages and Wake Time)
Time frame: 7 days (during one-week monitoring period)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Background: PubMed 20055267Bene 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.
- Background: PubMed 18344392Jankovic J. Parkinson's disease: clinical features and diagnosis. J Neurol Neurosurg Psychiatry. 2008 Apr;79(4):368-76. doi: 10.1136/jnnp.2007.131045.
- Background: PubMed 25904081Kalia 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Biruni University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Güzin Kaya Aytutuldu, phd (05366265884, guzinkaya14@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini Balance Evaluation Systems Test (Mini-BESTest) Score (time frame: Baseline (single assessment during study participation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07424924, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.