Enhancing Stability and Connection: A Manualized Recreational Therapy Balance Program for Older Adults With Parkinson's and Movement Disorders in Oklahoma Small Cities
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in gait velocity measured by the GAITRite system
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 预防
- 盲法
- 单盲 (结局评估者)
盲法说明
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.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 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
排除标准
- Medical condition that prevents safe participation in balance exercise
- Unable to attend the weekly in-person sessions
研究组 & 干预措施
24-week continuous balance program
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.
干预措施: Manualized recreational therapy balance program (Behavioral)
12-week balance program followed by 12-week observation
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.
干预措施: Manualized recreational therapy balance program (Behavioral)
结局指标
主要结局
Change in gait velocity measured by the GAITRite system
时间窗: 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.
次要结局
- 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)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT07845474
- 其他研究编号
- IRB-26-195
日期
- 首次提交
- (8天前)
- 首次发布
- (昨天)
- 主要完成日期
- (7个月后)
- 研究完成日期
- (7个月后)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否
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.