Cycling Intervention With Biofeedback of Power Symmetry for Patients With Stroke in an Inpatient Rehabilitation Facility: Pilot Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in cycling power
研究概览
简要总结
To determine changes in power symmetry, gait symmetry, and functional outcomes for participants' poststroke (Inpatient Rehabilitation Facility) after participating in an intervention using a recumbent cycle with power biofeedback (BFB). To determine how this intervention can impact gait asymmetry, a common disorder poststroke secondary to hemiparesis. Gait asymmetry is a difficult impairment to treat because it is difficult for both therapists and patients to perceive. Training with BFB allows for quantitative data about the power production or lack of that directly impacts safety in walking, increased energy expenditure, and decreased gait speed.
详细描述
Specific Aim 1 will determine the change in cycling power using BFB on a group of participants with stroke in an Inpatient Rehabilitation Facility. Specific Aim 2 will determine the effect size of the change in gait symmetry with cycling training with power BFB pre- to post-cycle intervention. Specific Aim 3 will determine the effect size of the change in functional mobility with cycling training with power BFB pre- to post-cycle intervention. Understanding the impact of cycle training with power BFB is an important step in improving stroke rehabilitation. This study is significant because it will provide data about power asymmetries in participants' early post-acute stroke and the transfer of training with power BFB to gait impairments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •they have a confirmed MCA or ACA ischemic or intracerebral hemorrhagic stroke, confirmed by CT/MRI or clinical documentation
- •AND demonstrating lower extremity hemiparesis [< 100 on lower limb Motricity Index24]
- •18 to 70 years of age
- •a Functional Ambulation Category of 2 (Dependent Level II) through 5 (Independent Level surfaces only)
- •medical clearance to participate
排除标准
- •contractures that limit lower limb range of motion
- •cardiovascular, respiratory or metabolic instability, including unstable angina or hypertension above 200/110 at rest
- •uncontrolled diabetes
- •severe respiratory disorders that limit exercise
- •inability to ambulate > 150 feet prior to stroke
- •prior history of peripheral or central nervous system injury
- •moderate to severe hemispatial neglect according to the Kessler Foundation Neglect Assessment
- •major cognitive impairment preventing the capability to understand training instructions; identified by inability to follow 3-step command
- •severe aphasia preventing communication with the therapist.
研究组 & 干预措施
Traditional rehabilitation
Participants will undergo traditional rehabilitation therapies in the inpatient rehabilitation facility.
干预措施: Traditional (Other)
cycle with biofeedback
Participants will undergo traditional rehabilitation therapies in the inpatient rehabilitation facility. They will also participate in the cycle intervention with biofeedback. This will take place as an additional rehabilitation session.
干预措施: cycle with biofeedback (Other)
结局指标
主要结局
Change in cycling power
时间窗: pre- (admission day 2) and post- (day 14)
Determine the change in cycling power using Biofeedback (BFB) on a group of participants with stroke in an Inpatient Rehabilitation Facility
Change in gait symmetry
时间窗: pre- (admission day 2) and post- (day 14)
Determine the effect size of the change in gait symmetry pre- to post-intervention after cycling with Biofeedback (BFB). Participants will be assessed on gait symmetry patterns (magnitude and timing of propulsion), using an instrumented treadmill (Bertec).
次要结局
未报告次要终点