Parkinson Disease (PD), Postural BalanceNCT07845474
A Manualized Recreational Therapy Balance Program for Older Adults With Parkinson's and Movement Disorders
A study testing Manualized recreational therapy balance program in people with Parkinson Disease (PD), Postural Balance and Movement Disorders (Incl Parkinsonism), run by Oklahoma State University at 1 site in United States.
Trial summary
This study evaluates a manualized recreational therapy balance program for older adults with Parkinson's disease and movement disorders who live in small cities and rural areas of Oklahoma, where access to movement disorder specialists is limited. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Parkinson Disease (PD), Postural Balance, Movement Disorders (Incl Parkinsonism), Postural Balance
- What is being tested?
- Manualized recreational therapy balance program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to 13 May 2027
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Parkinson's disease or another movement disorder
- Able to tolerate a 50-minute physical activity session once per week
- Able to attend in-person sessions at the study site
- Willing and able to provide informed consent
Who cannot join
- Medical condition that prevents safe participation in balance exercise
- Unable to attend the weekly in-person sessions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Legacy Village of Stillwater
Stillwater, Oklahoma, 74074
Lindsey Lovekamp, 405-714-6053, LindseyL@wslm.biz
About this study
Official title: Enhancing Stability and Connection: A Manualized Recreational Therapy Balance Program for Older Adults With Parkinson's and Movement Disorders in Oklahoma Small Cities
This study evaluates a manualized recreational therapy balance program for older adults with Parkinson's disease and movement disorders who live in small cities and rural areas of Oklahoma, where access to movement disorder specialists is limited.
Twenty-four older adults with Parkinson's disease and movement disorders will be randomly assigned to one of two groups of 12. One group will attend the balance program continuously for 24 weeks. The other group will attend the program for 12 weeks and will then be observed for 12 weeks without the program. All sessions are led by a Certified Therapeutic Recreation Specialist and last about 50 minutes once a week.
Read more
Participants will be assessed three times: before the program begins, at three months, and at six months. The assessments measure gait velocity and stride length, postural stability, fall-related confidence, anxiety and depression, and social connectedness.
The purpose of the study is to learn how long a community balance program needs to continue for older adults to keep the gains they make, and how quickly those gains decline when the program ends.
Read the detailed description
Parkinson's disease and movement disorders accelerate physical decline. In Oklahoma, more than 15,000 residents have Parkinson's disease, and about one-third live in rural areas. Rural isolation restricts access to movement disorder specialists, and fewer than 30% of individuals with Parkinson's disease engage in regular physical activity. Rural patients face barriers including limited transportation, fear of injury, and a lack of local programs or peer support.
This study evaluates a manualized recreational therapy balance protocol that was developed with funding from the American Parkinson Disease Association (FY2025-1461556). The evaluation is designed to determine the dosage of community-based exercise required to promote sustained mobility and to prevent the physical regression often seen after a program ends.
Design. Twenty-four older adults diagnosed with Parkinson's disease and movement disorders will be randomly assigned to two equal cohorts of 12 in a two-cohort comparative evaluation. Cohort 1 will receive the continuous in-person intervention for six months (24 weeks). Cohort 2 will receive the intervention for three months (12 weeks), followed by a three-month observation period intended to quantify the decay of training effects.
Setting. The intervention is delivered in person at Legacy Village of Stillwater, Oklahoma.
Participants. Participants must be able to tolerate a 50-minute physical session once per week.
Intervention. All sessions follow a manualized recreational therapy balance protocol and are directed by a Certified Therapeutic Recreation Specialist. The program includes static and dynamic balance training.
Assessments. Data are collected by a Certified Therapeutic Recreation Specialist and research assistants at baseline, month three, and month six. The GAITRite system (CIR Systems, New Jersey, USA) measures gait velocity and stride length. The BioSway system (Biodex Medical Systems, New York, USA) quantifies postural stability. Secondary outcomes are measured with the Short Falls Efficacy Scale-International for fall-related self-efficacy, the Hospital Anxiety and Depression Scale for psychological states, and the Lubben Social Network Scale for social connectedness.
Research questions. (1) Does a 24-week continuous manualized recreational therapy balance program yield higher retention of postural stability and gait velocity compared with a 12-week intervention followed by a 12-week observation period in adults with Parkinson's disease? (2) How do the two intervention durations differ in sustaining fall-related self-efficacy, reducing anxiety, and building social connectedness at the six-month benchmark? (3) What duration of CTRS-led community intervention establishes lasting independence for patients lacking access to movement disorder specialists?
Hypotheses. (1) The 24-week cohort retains baseline posture and gait velocity at month six, while the 12-week cohort experiences regression. (2) The 24-week cohort sustains fall confidence, reduces anxiety, and builds group bonds at month six. (3) The 24-week duration establishes the threshold for lasting patient independence.
Analysis. Analysis is conducted in collaboration with the Oklahoma State University Physical Activity and Public Health Lab using a two-way repeated-measures analysis of variance across three time points (baseline, week 12, and week 24), comparing the continuous cohort with the abbreviated cohort.
- Conditions
- Parkinson Disease (PD), Postural Balance, Movement Disorders (Incl Parkinsonism), Postural Balance, Accidental Falls
- Being tested
- Manualized recreational therapy balance program
- Keywords
- recreational therapy, balance training, fall prevention, gait velocity, postural stability, rural health, community-based intervention, older adults
- 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.
Manualized recreational therapy balance programBehavioural
A manualized balance training protocol delivered in person by a Certified Therapeutic Recreation Specialist in approximately 50-minute weekly sessions, including static and dynamic balance training. The protocol was developed with funding from the American Parkinson Disease Association.
| Study group | Role | What they receive |
|---|---|---|
| 24-week continuous balance program | Experimental | Participants attend the manualized recreational therapy balance program continuously for 24 weeks. Sessions are led by a Certified Therapeutic Recreation Specialist, last approximately 50 minutes, and are held once per week at Legacy Village of Stillwater. Sessions include static and dynamic balance training. Assessments are conducted at baseline, month three, and month six. Receives: Behavioral: Manualized recreational therapy balance program |
| 12-week balance program followed by 12-week observation | Active comparator | Participants attend the same manualized recreational therapy balance program for 12 weeks under the same schedule and format, and then enter a 12-week observation period during which the program is not provided. Assessments are conducted at baseline, month three, and month six. Receives: Behavioral: Manualized recreational therapy balance program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gait velocity measured by the GAITRite system
Gait velocity in centimeters per second measured with the GAITRite electronic walkway (CIR Systems, New Jersey, USA). Higher values indicate faster walking.
Measured: Baseline, 12 weeks, 24 weeks
Secondary outcomes (4)
Change in postural stability measured by the BioSway system
Postural stability measured with the BioSway balance system (Biodex Medical Systems, New York, USA). Higher sway values indicate poorer postural stability.
Measured: Baseline, 12 weeks, 24 weeks
Change in fall-related self-efficacy measured by the Short Falls Efficacy Scale-International (Short FES-I)
Seven-item scale scored from 7 to 28. Higher scores indicate greater concern about falling.
Measured: Baseline, 12 weeks, 24 weeks
Change in anxiety and depression measured by the Hospital Anxiety and Depression Scale (HADS)
Fourteen-item scale scored from 0 to 42. Higher scores indicate greater anxiety and depressive symptoms.
Measured: Baseline, 12 weeks, 24 weeks
Change in social connectedness measured by the Lubben Social Network Scale (LSNS)
Scale measuring perceived social network size and support. Higher scores indicate greater social connectedness.
Measured: Baseline, 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completion13 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease (PD), Postural BalanceStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel cohorts of 12 participants each. Cohort 1 receives the manualized recreational therapy balance program continuously for 24 weeks. Cohort 2 receives the same program for 12 weeks, followed by a 12-week observation period without the program.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oklahoma State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JungyuLee, Oklahoma State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845474
- Sponsor's protocol ID
- IRB-26-195
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly. The IRB-approved protocol and informed consent documents do not include provisions for sharing individual participant data outside the research team. De-identified aggregate results will be reported in peer-reviewed publications.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Stability and Connection: A Manualized Recreational Therapy Balance Program for Older Adults With Parkinson's and Movement Disorders in Oklahoma Small Cities
- ClinicalTrials.gov ID
- NCT07845474
- Acronym / sponsor ID
- IRB-26-195
- Conditions
- Parkinson Disease (PD), Postural Balance, Movement Disorders (Incl Parkinsonism), Postural Balance, Accidental Falls
- Keywords
- recreational therapy, balance training, fall prevention, gait velocity, postural stability, rural health, community-based intervention, older adults
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Oklahoma State UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- 13 May 2027 (estimated)
- First posted
- 29 Sep 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 evaluates a manualized recreational therapy balance program for older adults with Parkinson's disease and movement disorders who live in small cities and rural areas of Oklahoma, where access to movement disorder specialists is limited.
Twenty-four older adults with Parkinson's disease and movement disorders will be randomly assigned to one of two groups of 12. One group will attend the balance program continuously for 24 weeks. The other group will attend the program for 12 weeks and will then be observed for 12 weeks without the program. All sessions are led by a Certified Therapeutic Recreation Specialist and last about 50 minutes once a week.
Participants will be assessed three times: before the program begins, at three months, and at six months. The assessments measure gait velocity and stride length, postural stability, fall-related confidence, anxiety and depression, and social connectedness.
The purpose of the study is to learn how long a community balance program needs to continue for older adults to keep the gains they make, and how quickly those gains decline when the program ends.
Detailed description
Parkinson's disease and movement disorders accelerate physical decline. In Oklahoma, more than 15,000 residents have Parkinson's disease, and about one-third live in rural areas. Rural isolation restricts access to movement disorder specialists, and fewer than 30% of individuals with Parkinson's disease engage in regular physical activity. Rural patients face barriers including limited transportation, fear of injury, and a lack of local programs or peer support.
This study evaluates a manualized recreational therapy balance protocol that was developed with funding from the American Parkinson Disease Association (FY2025-1461556). The evaluation is designed to determine the dosage of community-based exercise required to promote sustained mobility and to prevent the physical regression often seen after a program ends.
Design. Twenty-four older adults diagnosed with Parkinson's disease and movement disorders will be randomly assigned to two equal cohorts of 12 in a two-cohort comparative evaluation. Cohort 1 will receive the continuous in-person intervention for six months (24 weeks). Cohort 2 will receive the intervention for three months (12 weeks), followed by a three-month observation period intended to quantify the decay of training effects.
Setting. The intervention is delivered in person at Legacy Village of Stillwater, Oklahoma.
Participants. Participants must be able to tolerate a 50-minute physical session once per week.
Intervention. All sessions follow a manualized recreational therapy balance protocol and are directed by a Certified Therapeutic Recreation Specialist. The program includes static and dynamic balance training.
Assessments. Data are collected by a Certified Therapeutic Recreation Specialist and research assistants at baseline, month three, and month six. The GAITRite system (CIR Systems, New Jersey, USA) measures gait velocity and stride length. The BioSway system (Biodex Medical Systems, New York, USA) quantifies postural stability. Secondary outcomes are measured with the Short Falls Efficacy Scale-International for fall-related self-efficacy, the Hospital Anxiety and Depression Scale for psychological states, and the Lubben Social Network Scale for social connectedness.
Research questions. (1) Does a 24-week continuous manualized recreational therapy balance program yield higher retention of postural stability and gait velocity compared with a 12-week intervention followed by a 12-week observation period in adults with Parkinson's disease? (2) How do the two intervention durations differ in sustaining fall-related self-efficacy, reducing anxiety, and building social connectedness at the six-month benchmark? (3) What duration of CTRS-led community intervention establishes lasting independence for patients lacking access to movement disorder specialists?
Hypotheses. (1) The 24-week cohort retains baseline posture and gait velocity at month six, while the 12-week cohort experiences regression. (2) The 24-week cohort sustains fall confidence, reduces anxiety, and builds group bonds at month six. (3) The 24-week duration establishes the threshold for lasting patient independence.
Analysis. Analysis is conducted in collaboration with the Oklahoma State University Physical Activity and Public Health Lab using a two-way repeated-measures analysis of variance across three time points (baseline, week 12, and week 24), comparing the continuous cohort with the abbreviated cohort.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two parallel cohorts of 12 participants each. Cohort 1 receives the manualized recreational therapy balance program continuously for 24 weeks. Cohort 2 receives the same program for 12 weeks, followed by a 12-week observation period without the program.
| Arm | Type | Receives |
|---|---|---|
| 24-week continuous balance program | Experimental | Behavioral: Manualized recreational therapy balance programParticipants attend the manualized recreational therapy balance program continuously for 24 weeks. Sessions are led by a Certified Therapeutic Recreation Specialist, last approximately 50 minutes, and are held once per week at Legacy Village of Stillwater. Sessions include static and dynamic balance training. Assessments are conducted at baseline, month three, and month six. |
| 12-week balance program followed by 12-week observation | Active comparator | Behavioral: Manualized recreational therapy balance programParticipants attend the same manualized recreational therapy balance program for 12 weeks under the same schedule and format, and then enter a 12-week observation period during which the program is not provided. Assessments are conducted at baseline, month three, and month six. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of Parkinson's disease or another movement disorder
- Able to tolerate a 50-minute physical activity session once per week
- Able to attend in-person sessions at the study site
- Willing and able to provide informed consent
Key exclusion criteria (2 listed)
- Medical condition that prevents safe participation in balance exercise
- Unable to attend the weekly in-person sessions
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 |
|---|---|---|
| Manualized recreational therapy balance programA manualized balance training protocol delivered in person by a Certified Therapeutic Recreation Specialist in approximately 50-minute weekly sessions, including static and dynamic balance training. The protocol was developed with funding from the American Parkinson Disease Association. | Behavioural | 12-week balance program followed by 12-week observation, 24-week continuous balance program |
Primary outcome
Change in gait velocity measured by the GAITRite system
Time frame: Baseline, 12 weeks, 24 weeks
Gait velocity in centimeters per second measured with the GAITRite electronic walkway (CIR Systems, New Jersey, USA). Higher values indicate faster walking.
4 secondary outcomes
Change in postural stability measured by the BioSway system
Time frame: Baseline, 12 weeks, 24 weeks
Change in fall-related self-efficacy measured by the Short Falls Efficacy Scale-International (Short FES-I)
Time frame: Baseline, 12 weeks, 24 weeks
Change in anxiety and depression measured by the Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, 12 weeks, 24 weeks
Change in social connectedness measured by the Lubben Social Network Scale (LSNS)
Time frame: Baseline, 12 weeks, 24 weeks
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 29 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly. The IRB-approved protocol and informed consent documents do not include provisions for sharing individual participant data outside the research team. De-identified aggregate results will be reported in peer-reviewed publications.
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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?
A study testing Manualized recreational therapy balance program in people with Parkinson Disease (PD), Postural Balance and Movement Disorders (Incl Parkinsonism), run by Oklahoma State University 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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 29 Sep 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 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?
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 Jungyu Lee, PhD (405-762-1844, jungyu.lee@okstate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gait velocity measured by the GAITRite system (time frame: Baseline, 12 weeks, 24 weeks). 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 29 Sep 2026.