Golf, Physical Rehabilitation, and Movement Disorders | NCT05651776

Studies
Golf, Physical Rehabilitation, and Movement Disorders

NCT05651776

Sponsor

University of Florida

Status

Completed

Last Update Posted

Jun 6, 2024Actual

Enrollment

9Actual

Phase

Not Applicable

Conditions

Parkinson Disease, Movement Disorders

Interventions

Physical Therapy, Exercise

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2023Actual

Primary Completion Date

Aug 14, 2023Actual

Completion Date

Dec 5, 2023Actual

First Submitted Date

Dec 2, 2022

First Submission Date that Met QC Criteria

Dec 14, 2022

First Posted Date

Dec 15, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 4, 2024

Last Update Posted Date

Jun 6, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention of golf and rehab	Experimental	2x/week x 6 weeks participation in a golf and PD rehab program	Other: Physical Therapy, Exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Physical Therapy, Exercise	Other	Outpatient physical therapy intervention incorporating golf related assessment of skills and prescribed exercises including postural, balance, and club swing

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in functional gait assessment	Scale that measures ambulation quality	Scale completed at baseline and at 6 weeks of treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

105 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joseph Legacy, MD	UF Health Neurology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Florida		Jacksonville	Florida	32209	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease
D009069	Movement Disorders

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D026741	Physical Therapy Modalities
D015444	Exercise

Ancestor Terms

ID	Term
D013812	Therapeutics
D012046	Rehabilitation
D009043	Motor Activity
D009068	Movement

Browse Leaves

Not provided

Browse Branches

Not provided