A Pilot Dual-Task Treadmill Training to Improve Gait and Balance in Fragile X-Associated Tremor/Ataxia Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- High levels of recruitment
研究概览
简要总结
A pilot trial to determine the feasibility of treadmill training with dual training in patients with Fragile X-Associated Tremor/Ataxia Syndrome (FXTAS).
详细描述
There is substantial evidence that physical exercise can improve motor and cognitive function in individuals with Parkinson's Disease, traumatic brain injury or chronic stroke survivors. However, to the investigator's knowledge, no studies have explored the effect of treadmill training with or without a cognitive dual Task on gait, balance and cognition in Fragile X - Associated Tremor/Ataxia Syndrome (FXTAS), which is characterized by action tremor, cerebellar gait ataxia, parkinsonism, peripheral neuropathy and cognitive deficits, all of which increase the risk for falls and progressive disability. There are presently no medications or treatment interventions that have been shown to effectively manage the symptoms of FXTAS or delay disease progression, and it is currently not clear whether either the ST or Dual-Task treadmill training paradigms would be feasible or effective in FXTAS.
A total of 10 individuals with FXTAS will recruited from the Rush University Movement Disorders Clinic or the FXTAS Clinic Database at Rush University. The subjects will be assigned to either 6 weeks of dual-task treadmill exercise training combined with a cognitive task (intervention group) occurring 3 times weekly, or control group. The primary outcome measures will be feasibility, safety and patient adherence. The assessments will occur at baseline, week 3, week 6, 1 month & 6 month post-training.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •A diagnosis of possible, probable or definite FXTAS
- •Able to stand and walk without support for 2 minutes
排除标准
- •Any neurologic or musculoskeletal problems
- •History of traumatic brain injury
- •Significant cardiopulmonary or cardiovascular disease
- •Dementia or other significant cognitive impairment
- •Unstable psychiatric disorders
结局指标
主要结局
High levels of recruitment
时间窗: 6 months
Research subjects were recruited using a recruitment flyer for the study and tracked by the number of willing participants.
High levels of program attendance, and retention
时间窗: 6 weeks
At each study visit the subjects attend and revisit were taken down throughout the entire intervention period in an attendance/retention log book.
High levels of satisfaction
时间窗: 6 weeks
At the end of the entire study a client satisfaction questionnaire was administered and interpreted based on a percent of satisfaction, ranging from zero to one hundred percent, on various satisfactory questions. Zero percent meaning highly unsatisfied and one hundred percent meaning highly satisfied.
次要结局
- Change in balance and mobility measured by Instrumented-SWAY (i-SWAY)(6 weeks)
- Change in cognitive function measured by the Montreal Cognitive ASsessment (MoCa)(6 months)
- Change in cognitive function measured by (STROOP)(6 weeks)
- Change in patient reported confidence in balance measured by Activities-Specific Balance Confidence Scale (ABC)(baseline, week 6, post-training month 1 & month 6)
- Change in cognitive function measured by Controlled Oral Word Association Test (COWAT)(6 weeks)
- Change in cognitive function measured by Digit Span forward and backward test(6 weeks)
- Change in balance and mobility measured by Mini-BEST balance scale(6 weeks)
- Change in cognitive function measured by the Symbol Digit Modalities Test (SDMT)(6 weeks)
- Change in quality of sleep measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire(6 weeks)
- Change in functional mobility measured by Instrumented-WALK (i-WALK)(6 weeks)
- Change in health related quality of life measured by the Neuro Quality of Life Survey(6 months)
- Change in depression measured by the Center for Epidemiologic Studies Depression Scale (CES-D)(6 weeks)
- Change in perceived exertion on physical activity intensity measured by the Borg Rating Scale (Borg Rating of Perceived Exertion Scale)(6 weeks)
- Change in physical activity level measured step counts monitored by Fitbit wrist watch(6 weeks)
- Change in anxiety measured by the Beck Anxiety Inventory (BAI).(6 weeks)