Parkinson DiseaseNCT04189042
Figure-of-Eight Walk Test in Parkinson
An observational study of Parkinson Disease, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
The aim of study is to assess validity and reliability of Figure-of-Eight Walk Test in people with Parkinson's Disease Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Dec 2019to 31 May 2021
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Parkinson's Disease who apply to the Gazi University, Department of Physiotherapy and Rehabilitation will be invited to this study.
Who may be able to join
- at least 40 years of age
- neurologist-diagnosed Parkinson's Disease
- Hoehn \& Yahr (H\&Y) stages 1 to 3
- able to walk at least 20 meters
Who cannot join
- other neurologic disorder
- visual, auditory, orientational problems that could affect study results
- any orthopedic problem that prevents walking and standing
- have a cardiovascular, pulmonary or hormonal disorder
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University, Faculty of Health Sciences
Ankara, 06560
About this study
Official title: Assessing Validity and Reliability of Figure-of-Eight Walk Test in People With Parkinson's Disease
The aim of study is to assess validity and reliability of Figure-of-Eight Walk Test in people with Parkinson's Disease
- Conditions
- Parkinson Disease
- 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 |
|---|---|---|
| Parkinson Group | Patients with Parkinson's Disease (Hoehn and Yahr stage 1-4) | |
| Healthy Control | Healthy People |
What is being measured
The primary outcome is the main question the study is designed to answer.
Figure-of-Eight Walk Test
Figure-of-Eight Walk Test involves straight and curved paths in order to assess the advanced walking performance required in daily life.The subject walks a "figure 8" pattern around two cones spaced 5 ft apart, and the time and number of steps needed to complete the assessment are recorded.
Measured: 10-15 seconds
Secondary outcomes (6)
Unified Parkinson's Disease Rating Scale
The Unified Parkinson's Disease Rating Scale (UPDRS) is a widely used measure of impairment and disability associated with Parkinson's Disease (PD) consisting of four sections: (1) Mentation, behavior, and mood; (2) Activities of daily living (ADLs); (3) Motor; and (4) Complications.Sections I through III are scored using a 5-point Likert-type scale (0 = no impairment; 4 = marked impairment). Although individual sections are scored and reported independently, scores from sections I through III are also summed to provide a UPDRS Total score. The UPDRS total score ranges between 0 and 199 points. Higher points indicates worse outcome.
Measured: 15 minutes
Hoehn and Yahr Scale
Disease stage is assessed by the Hoehn and Yahr Scale. The Hoehn and Yahr scale is a commonly used diagnostic tool for quantifying the progression of Parkinson's Disease symptoms. Stages range from 0 (no signs of disease) to 5 (requiring a wheelchair, or bedridden unless assisted).
Measured: 1 minutes
Timed Up and Go Test
Functional mobility is assessed by using the timed up and go test. The timed up and go test measures the time that a patient needs to stand up from a chair, walk a 3-m distance, come back and sit back on the chair.
Measured: 10-15 seconds
Berg Balance Scale
Berg Balance Scale (BBS) is a scale that using for assess postural stability. It ranges 0-56 with higher score indicates better stability.
Measured: 10-15 minutes
10 Meter Walk Test
10 Meter Walk Test measures the time required to complete straight walk of 10 meters distance.
Measured: 10-15 seconds
Activities-Specific Balance Confidence (ABC) Scale
Activities-specific Balance Confidence scale (ABC), to quantify the level of confidence in performing a specific task without losing balance or becoming unsteady.The ABC scale is a self-reported questionnaire providing information on balance confidence in the performance of 16 different daily activities, such as stair climbing, walking in the house, and walking on slippery floors. The questionnaire contains 16 items scored on a range from 0% to 100% (0 indicating no confidence and 100 indicating full confidence).
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start11 Dec 2019
- Primary completion30 Mar 2021 (estimated)
- Study completion31 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Gazi 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çağrı Gülşen, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04189042
- Sponsor's protocol ID
- 2019.19.164
- Status last verified
- Feb 2021
- First submitted
- 4 Dec 2019
- Last updated
- 4 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Validity and Reliability of Figure-of-Eight Walk Test in People With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04189042
- Acronym / sponsor ID
- 2019.19.164
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 11 Dec 2019 (actual)
- Primary completion
- 30 Mar 2021 (estimated)
- Study completion
- 31 May 2021 (estimated)
- First posted
- 6 Dec 2019 (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.
The aim of study is to assess validity and reliability of Figure-of-Eight Walk Test in people with Parkinson's Disease
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson Group | – | –Patients with Parkinson's Disease (Hoehn and Yahr stage 1-4) |
| Healthy Control | – | –Healthy People |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Parkinson's Disease who apply to the Gazi University, Department of Physiotherapy and Rehabilitation will be invited to this study.
Key inclusion criteria (4 listed)
- at least 40 years of age
- neurologist-diagnosed Parkinson's Disease
- Hoehn \& Yahr (H\&Y) stages 1 to 3
- able to walk at least 20 meters
Key exclusion criteria (4 listed)
- other neurologic disorder
- visual, auditory, orientational problems that could affect study results
- any orthopedic problem that prevents walking and standing
- have a cardiovascular, pulmonary or hormonal disorder
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
Figure-of-Eight Walk Test
Time frame: 10-15 seconds
Figure-of-Eight Walk Test involves straight and curved paths in order to assess the advanced walking performance required in daily life.The subject walks a "figure 8" pattern around two cones spaced 5 ft apart, and the time and number of steps needed to complete the assessment are recorded.
6 secondary outcomes
Unified Parkinson's Disease Rating Scale
Time frame: 15 minutes
Hoehn and Yahr Scale
Time frame: 1 minutes
Timed Up and Go Test
Time frame: 10-15 seconds
Berg Balance Scale
Time frame: 10-15 minutes
10 Meter Walk Test
Time frame: 10-15 seconds
Activities-Specific Balance Confidence (ABC) Scale
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Gazi 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 4 Feb 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Figure-of-Eight Walk Test (time frame: 10-15 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2021.