About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Medical condition that prevents safe participation in balance exercise
Unable to attend the weekly in-person sessions
Trial design
Parallel
Treatments tested in this trial
Manualized recreational therapy balance program
BehavioralA 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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