The Effect of Powered-Knee Exoskeleton Assist on Stair Climbing in Acute Cerebrovascular Accidents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Change in Timed Stair Climb Test speed from baseline
研究概览
简要总结
Hypothesis/Specific Aims: The purpose of this research study is to determine if using an exoskeleton during stair climbing training will result in an improved ability to walk and climb stairs in individuals affected by recent stroke as compared to stair climbing training without an exoskeleton.
详细描述
Participants will be randomized into one of two groups. Group 1 will wear the exoskeleton device while completing all training sessions. Group 2 will not wear the exoskeleton device during training sessions. All screening and evaluation sessions will be completed without the exoskeleton device for both Group 1 and Group 2. Pre and post-session vitals (blood pressure, heart rate) will be taken and monitored throughout the session as needed. Gait belts and/or overhead track and harnessing systems will be used throughout sessions as needed for increased safety of participants. Skin integrity will also be monitored both before and after each use of the exoskeleton device.
Each enrolled participant will complete the following sessions:
Session 1: Screening
- After consenting, subjects will undergo a physical evaluation and screening exam by a licensed physical therapist. If they meet study criteria, they will be randomly placed into either the Keeogo group or the traditional stair training group using a random number generator and they will be entered into the study. Once they are enrolled, baseline outcome measures will be assessed.
Sessions 2 through 6: Training
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient in the inpatient rehabilitation setting
- •less that 3 months post-hemorrhagic or ischemic cerebrovascular accident (CVA)
- •No previous diagnosis or treatment for CVA
- •Acute inpatient rehabilitation discharge goal of stair negotiation
- •18 years of age or older
- •Waist and leg circumference and lower extremity lengths appropriate for a comfortable and safe fit in the Keeogo study device
- •Medical clearance from a Shirley Ryan AbilityLab (SRALAB) inpatient physician
排除标准
- •Unwilling to participate
- •Unable to provide autonomous consent due to cognitive or communication impairment
- •Legally blind
- •Pregnant or lactating
- •Skin condition that contraindicates use of orthotics or support braces
- •History of multiple CVA
- •History of any additional neuropathology diagnosis, such as Parkinson's disease, multiple sclerosis, traumatic brain injury, or spinal cord injury
结局指标
主要结局
Change in Timed Stair Climb Test speed from baseline
时间窗: Initial Visit (Week 1); Post testing (Week 2)
The timed stair test is best conducted in a standard interior stair-well with guard rails and preferably 10 steps between landings, with a minimum of 8 steps and a maximum of 12 steps. The landing space is required to ensure safe turning. The patient will be instructed to ascend and descend the stair case "as quickly and safely" as possible. To start the test, the patient is asked to stand at the bottom of the stair case, and a countdown provided "one, two, ready, go" where the patient initiates stair ascent at the "go" cue, and the tester starts the stop watch. • The patient ascends the stair case, turns and descends the stair case, coming to a stop at the bottom of the stair case. The tester will lap the time for the ascent period and the descend period, and records these "Test 1" times. This will be repeated for a total of two trials.
次要结局
- 5-times Sit to Stand Test(Initial Visit (Week 1); Post testing (Week 2))
- GAITRite Data Collection(Initial Visit (Week 1); Post testing (Week 2))
研究者
Arun Jayaraman, PT, PhD
Principal Investigator
Shirley Ryan AbilityLab