Parkinson DiseaseNCT04267341
Effect of Dual Task on Upper and Lower Extremity Skills in Parkinson's Disease
An observational study of Parkinson Disease and Movement Disorders, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to investigate the change of lower and upper extremity skills with dual task in Parkinson's disease patients and to determine the differences between Parkinson's disease patients with different stages of disease and the healthy controls regarding the change of lower and upper extremity skills… 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, Movement Disorders
- What is being tested?
- Timed Up and Go Test, 10 Meter Walk Test and Purdue Pegboard Test
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 1 Aug 2020
- How long will I take part?
- 1 Day
- 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 Hacettepe University, Faculty of Physiotherapy and Rehabilitation, Department of Neurological Rehabilitation will be invited to this study.
Who may be able to join
- Modified Hoehn \& Yahr (H\&Y) stages 1 to 3
- at least 40 years of age
- 21 or more MoCA score.
Who cannot join
- other neurologic disorder
- any orthopedic problem that could prevent to participate in the study
- severe dyskinesia or tremor
- visual or speech problems
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University, Faculty of Physical Therapy and Rehabilitation
Ankara, 06100
About this study
Official title: Examining The Change of Upper and Lower Extremity Skills With The Effect of Dual Task in Parkinson's Disease Patients
The aim of the study is to investigate the change of lower and upper extremity skills with dual task in Parkinson's disease patients and to determine the differences between Parkinson's disease patients with different stages of disease and the healthy controls regarding the change of lower and upper extremity skills with dual task.
- Conditions
- Parkinson Disease, Movement Disorders
- Being tested
- Timed Up and Go Test, 10 Meter Walk Test, Purdue Pegboard Test
- Medical subject headings
- Parkinson Disease, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timed Up and Go TestOther
It requires individual to stand up from an armed chair, walk 3m, turn around, walk back to the armed chair, and sit down again
10 Meter Walk TestOther
10 Meter Walk Test measures the time required to complete straight walk of 10 meters distance
Purdue Pegboard TestOther
Purdue Pegboard test evaluates the fine manuel dexterity
| Study group | Role | What they receive |
|---|---|---|
| Mild Stage Parkinson's Disease Patients | Modified Hoehn and Yahr stage 1-2 Receives: Other: Timed Up and Go Test; Other: 10 Meter Walk Test; Other: Purdue Pegboard Test | |
| Moderate Stage Parkinson's Disease Patients | Modified Hoehn and Yahr stage 2.5-3 Receives: Other: Timed Up and Go Test; Other: 10 Meter Walk Test; Other: Purdue Pegboard Test | |
| Healthy Control | Healthy People Receives: Other: Timed Up and Go Test; Other: 10 Meter Walk Test; Other: Purdue Pegboard Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
10 Meter Walk Test
10 Meter Walk Test measures the time required to complete straight walk of 10 meters distance.
Measured: 10-15 seconds
Purdue Pegboard Test
Purdue Pegboard Test assesses the speed and motor dexterity of each hand and the manual dexterity using both hands at the same time. The PPT consists of a board with two columns with 25 holes each and a specific number of pins, washers and collars placed in four containers across the top of the board.
Measured: 3-5 minutes
Secondary outcomes (3)
Modified Hoehn and Yahr Scale
Modified Hoehn and Yahr Scale allocates stages from 0 to 5 to indicate the relative level of disability and stage of disease. Higher level indicates worse physical condition.
Measured: 1 minute
Montreal Cognitive Assessment (MoCA)
Montreal Cognitive Assessment (MoCA) will be used in order to evaluate cognition. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.It' score ranged from 0 to 30 and higher points indicates better cognitive outcomes.
Measured: 10-15 minutes
Short-Form 8-Item Parkinson's Disease Questionnaire (PDQ-8)
The short-form 8-item Parkinson's disease Questionnaire (PDQ-8) is the most commonly used scale measuring health related quality of life (HRQoL) in PD patients. It includes 8 items, and each item has five options (never, occasionally, sometimes, often, always or cannot do at all). The total score ranges from 0 to 32. Higher scores indicates poorer quality of life.
Measured: 1-2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start1 Jan 2020
- Primary completion15 Mar 2020
- Study completion1 Aug 2020
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 Hacettepe 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
- 45 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elvan ÖZCAN GÜLŞEN, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04267341
- Sponsor's protocol ID
- 2019/24-01
- Status last verified
- Dec 2020
- First submitted
- 11 Feb 2020
- Last updated
- 3 Dec 2020
- Results posted
- No
- Data monitoring committee
- 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 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining The Change of Upper and Lower Extremity Skills With The Effect of Dual Task in Parkinson's Disease Patients
- ClinicalTrials.gov ID
- NCT04267341
- Acronym / sponsor ID
- 2019/24-01
- Conditions
- Parkinson Disease, Movement Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 12 Feb 2020 (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 the study is to investigate the change of lower and upper extremity skills with dual task in Parkinson's disease patients and to determine the differences between Parkinson's disease patients with different stages of disease and the healthy controls regarding the change of lower and upper extremity skills with dual task.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild Stage Parkinson's Disease Patients | – | Other: Timed Up and Go Test, Other: 10 Meter Walk Test, Other: Purdue Pegboard TestModified Hoehn and Yahr stage 1-2 |
| Moderate Stage Parkinson's Disease Patients | – | Other: Timed Up and Go Test, Other: 10 Meter Walk Test, Other: Purdue Pegboard TestModified Hoehn and Yahr stage 2.5-3 |
| Healthy Control | – | Other: Timed Up and Go Test, Other: 10 Meter Walk Test, Other: Purdue Pegboard TestHealthy 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 Hacettepe University, Faculty of Physiotherapy and Rehabilitation, Department of Neurological Rehabilitation will be invited to this study.
Key inclusion criteria (3 listed)
- Modified Hoehn \& Yahr (H\&Y) stages 1 to 3
- at least 40 years of age
- 21 or more MoCA score.
Key exclusion criteria (4 listed)
- other neurologic disorder
- any orthopedic problem that could prevent to participate in the study
- severe dyskinesia or tremor
- visual or speech problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Timed Up and Go TestIt requires individual to stand up from an armed chair, walk 3m, turn around, walk back to the armed chair, and sit down again | Other | Healthy Control, Mild Stage Parkinson's Disease Patients, Moderate Stage Parkinson's Disease Patients |
| 10 Meter Walk Test10 Meter Walk Test measures the time required to complete straight walk of 10 meters distance | Other | Healthy Control, Mild Stage Parkinson's Disease Patients, Moderate Stage Parkinson's Disease Patients |
| Purdue Pegboard TestPurdue Pegboard test evaluates the fine manuel dexterity | Other | Healthy Control, Mild Stage Parkinson's Disease Patients, Moderate Stage Parkinson's Disease Patients |
Primary outcome
Timed Up and Go Test
Time frame: 10-15 seconds
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.
10 Meter Walk Test
Time frame: 10-15 seconds
10 Meter Walk Test measures the time required to complete straight walk of 10 meters distance.
Purdue Pegboard Test
Time frame: 3-5 minutes
Purdue Pegboard Test assesses the speed and motor dexterity of each hand and the manual dexterity using both hands at the same time. The PPT consists of a board with two columns with 25 holes each and a specific number of pins, washers and collars placed in four containers across the top of the board.
3 secondary outcomes
Modified Hoehn and Yahr Scale
Time frame: 1 minute
Montreal Cognitive Assessment (MoCA)
Time frame: 10-15 minutes
Short-Form 8-Item Parkinson's Disease Questionnaire (PDQ-8)
Time frame: 1-2 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- 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 and Movement Disorders, run by Hacettepe 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 3 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: finished, as of the sponsor's last update on 3 Dec 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Timed Up and Go Test (time frame: 10-15 seconds). The study lists 3 primary outcomes in all. 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 3 Dec 2020.