Parkinson Disease, Movement DisordersNCT05651776
Golf, Physical Rehabilitation, and Movement Disorders
A study testing Physical Therapy, Exercise in people with Parkinson Disease, Movement Disorders, run by University of Florida at 1 site in United States.
Trial summary
The importance of physical activity for individuals with movement disorders, including Parkinson disease and Essential tremor, has been established. Barriers including patient engagement continue to limit effectiveness. Golf requires skills found challenging to individuals with movement disorders. Read more about this study
- Who is it for?
- Ages 18 to 105 years
- Conditions the study is for
- Parkinson Disease, Movement Disorders
- What is being tested?
- Physical Therapy, Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 5 Dec 2023
- Phase
- Interventional
- 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 18 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of either PD, Parkinsonism, or ET. Subjects must also demonstrate functional deficits in at least one of the three categories (gait, transfers, balance) to be further assessed by the evaluating PT
Who cannot join
- Subjects will be excluded if they are unable to maintain standing balance with an assistive device, if they are non-ambulatory even with a device, if pain does not allow for subject participation, and if they are unable to follow instructions due to an underlying attentional or cognitive deficit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Outpatient Physical Therapy and Golf Program Designed for Individuals With Movement Disorders
The importance of physical activity for individuals with movement disorders, including Parkinson disease and Essential tremor, has been established. Barriers including patient engagement continue to limit effectiveness. Golf requires skills found challenging to individuals with movement disorders. This study seeks to assess the feasibility and effectiveness of an outpatient-based rehabilitation program incorporating golf skills and activities on functional measures and quality of life.
- Conditions
- Parkinson Disease, Movement Disorders
- Being tested
- Physical Therapy, Exercise
- 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.
Physical Therapy, ExerciseOther
Outpatient physical therapy intervention incorporating golf related assessment of skills and prescribed exercises including postural, balance, and club swing
| Study group | Role | What they receive |
|---|---|---|
| Intervention of golf and rehab | Experimental | 2x/week x 6 weeks participation in a golf and PD rehab program Receives: Other: Physical Therapy, Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in functional gait assessment
Scale that measures ambulation quality
Measured: Scale completed at baseline and at 6 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start1 Feb 2023
- Primary completion14 Aug 2023
- Study completion5 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease, Movement DisordersStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Legacy, MD, Principal investigator, UF Health Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651776
- Sponsor's protocol ID
- 202202232
- Status last verified
- Jun 2024
- First submitted
- 2 Dec 2022
- Last updated
- 6 Jun 2024
- 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 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Outpatient Physical Therapy and Golf Program Designed for Individuals With Movement Disorders
- ClinicalTrials.gov ID
- NCT05651776
- Acronym / sponsor ID
- 202202232
- Conditions
- Parkinson Disease, Movement Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 14 Aug 2023 (actual)
- Study completion
- 5 Dec 2023 (actual)
- First posted
- 15 Dec 2022 (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 importance of physical activity for individuals with movement disorders, including Parkinson disease and Essential tremor, has been established. Barriers including patient engagement continue to limit effectiveness. Golf requires skills found challenging to individuals with movement disorders. This study seeks to assess the feasibility and effectiveness of an outpatient-based rehabilitation program incorporating golf skills and activities on functional measures and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention of golf and rehab | Experimental | Other: Physical Therapy, Exercise2x/week x 6 weeks participation in a golf and PD rehab program |
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of either PD, Parkinsonism, or ET. Subjects must also demonstrate functional deficits in at least one of the three categories (gait, transfers, balance) to be further assessed by the evaluating PT
Key exclusion criteria (1 listed)
- Subjects will be excluded if they are unable to maintain standing balance with an assistive device, if they are non-ambulatory even with a device, if pain does not allow for subject participation, and if they are unable to follow instructions due to an underlying attentional or cognitive deficit.
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 |
|---|---|---|
| Physical Therapy, ExerciseOutpatient physical therapy intervention incorporating golf related assessment of skills and prescribed exercises including postural, balance, and club swing | Other | Intervention of golf and rehab |
Primary outcome
Change in functional gait assessment
Time frame: Scale completed at baseline and at 6 weeks of treatment
Scale that measures ambulation quality
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 6 Jun 2024.
- 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.
Joseph Legacy, MD principal investigator
UF Health Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy, Exercise in people with Parkinson Disease, Movement Disorders, run by University of Florida at 1 site in United States.
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 1 inclusion and 1 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 6 Jun 2024. 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 United States. 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?
Change in functional gait assessment (time frame: Scale completed at baseline and at 6 weeks of treatment). 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 6 Jun 2024.