[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658154":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":37,"studyPopulation":26,"armGroups":38,"interventions":50,"overallOfficials":26,"centralContacts":56,"locations":66,"responsibleParty":85,"collaborators":26,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":26,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":26,"enrollmentInfo":98,"targetDuration":26,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":110,"overallStatus":119,"whyStopped":26,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Oklahoma State University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"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",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"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.",{"measure":18,"description":19,"timeFrame":12},"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.",{"measure":21,"description":22,"timeFrame":12},"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.",{"measure":24,"description":25,"timeFrame":12},"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.",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":30,"primaryPurpose":31,"observationalModel":26,"timePerspective":26,"maskingInfo":32},"RANDOMIZED","PARALLEL","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.","PREVENTION",{"masking":33,"maskingDescription":34,"whoMasked":35},"SINGLE","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.",[36],"OUTCOMES_ASSESSOR","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.\n\nThis 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.\n\nDesign. 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.\n\nSetting. The intervention is delivered in person at Legacy Village of Stillwater, Oklahoma.\n\nParticipants. Participants must be able to tolerate a 50-minute physical session once per week.\n\nIntervention. 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.\n\nAssessments. 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.\n\nResearch 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?\n\nHypotheses. (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.\n\nAnalysis. 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.",[39,45],{"label":40,"type":41,"description":42,"interventionNames":43},"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.",[44],"Behavioral: Manualized recreational therapy balance program",{"label":46,"type":47,"description":48,"interventionNames":49},"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.",[44],[51],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":26},"BEHAVIORAL","Manualized recreational therapy balance program","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.",[46,40],[57,62],{"name":58,"role":59,"phone":60,"phoneExt":26,"email":61},"Jungyu Lee, PhD","CONTACT","405-762-1844","jungyu.lee@okstate.edu",{"name":63,"role":59,"phone":64,"phoneExt":26,"email":65},"Tim Passmore, Ed.D.","405-744-1811","tim.passmore@okstate.edu",[67],{"facility":68,"status":26,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Legacy Village of Stillwater","Stillwater","Oklahoma","74074","United States","US",{"type":75,"coordinates":76},"Point",[77,78],-97.05837,36.11561,{"lat":78,"lon":77},[81],{"name":82,"role":59,"phone":83,"phoneExt":26,"email":84},"Lindsey Lovekamp","405-714-6053","LindseyL@wslm.biz",{"type":86,"investigatorFullName":87,"investigatorTitle":88,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","JungyuLee","Postdoctoral Fellow","100658154","a-manualized-recreational-therapy-balance-program-for-older-adults-with-parkinsons-and-movement-disorders-100658154",false,"NCT07845474","A Manualized Recreational Therapy Balance Program for Older Adults With Parkinson's and Movement Disorders","Enhancing Stability and Connection: A Manualized Recreational Therapy Balance Program for Older Adults With Parkinson's and Movement Disorders in Oklahoma Small Cities","Inclusion Criteria:\n\n* Diagnosis of Parkinson's disease or another movement disorder\n* Able to tolerate a 50-minute physical activity session once per week\n* Able to attend in-person sessions at the study site\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Medical condition that prevents safe participation in balance exercise\n* Unable to attend the weekly in-person sessions","ALL","50 Years",{"count":99,"type":100},24,"ESTIMATED","INTERVENTIONAL",[103],"NA","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.\n\nTwenty-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.\n\nParticipants 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.\n\nThe 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.",[106,107,108,109],"Parkinson Disease (PD), Postural Balance","Movement Disorders (Incl Parkinsonism)","Postural Balance","Accidental Falls",[111,112,113,114,115,116,117,118],"recreational therapy","balance training","fall prevention","gait velocity","postural stability","rural health","community-based intervention","older adults","NOT_YET_RECRUITING","2026-09-22",{"date":122,"type":123},"2026-09-29","ACTUAL",{"date":125,"type":100},"2026-10",{"date":127,"type":100},"2027-05-13",{"name":5,"class":6},1]