A Manualized Recreational Therapy Balance Program for Older Adults With Parkinson's and Movement Disorders

NCT07845474 | Not Yet Recruiting

• 1 other identifier: IRB-26-195
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 12 weeks, 24 weeks

Secondary Outcomes (4)

• Change in postural stability measured by the BioSway system

  Baseline, 12 weeks, 24 weeks

• Change in fall-related self-efficacy measured by the Short Falls Efficacy Scale-International (Short FES-I)

  Baseline, 12 weeks, 24 weeks

• Change in anxiety and depression measured by the Hospital Anxiety and Depression Scale (HADS)

  Baseline, 12 weeks, 24 weeks

• Change in social connectedness measured by the Lubben Social Network Scale (LSNS)

  Baseline, 12 weeks, 24 weeks

Study Arms (2)

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.

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.

Behavioral: Manualized recreational therapy balance program

Interventions

Manualized recreational therapy balance program BEHAVIORAL

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.

12-week balance program followed by 12-week observation; 24-week continuous balance program

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Medical condition that prevents safe participation in balance exercise
• Unable to attend the weekly in-person sessions

Sponsors & Collaborators

• Oklahoma State University: lead

Study Sites (1)

Legacy Village of Stillwater

Stillwater, Oklahoma, 74074, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Movement Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Jungyu Lee, PhD

CONTACT

405-762-1844; jungyu.lee@okstate.edu

Tim Passmore, Ed.D.

CONTACT

405-744-1811; tim.passmore@okstate.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessments are conducted by staff who are not informed of cohort assignment. Participants and the interventionist cannot be masked because of the nature of the intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Fellow

Model Details: 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.

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: September 29, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 13, 2027
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)