Feasibility of High and Low Intensity Virtual Reality Gait Training in Individuals with Chronic Stroke: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- 6 minute walk test
研究概览
简要总结
The purpose of this pilot study is to investigate the feasibility of 1) providing virtual reality walking training using a custom developed setup able to be replicated in routine clinical practice and 2) combining the virtual reality training with high-intensity gait training.
详细描述
This study will utilize a randomized-crossover design. Following confirmation of eligibility and completion of Baseline 1 testing, individuals will be randomized to receive up to 15 visits over approximately 5 weeks of either high or low intensity virtual reality gait training. Following which, individuals will undergo Post 1 testing to capture potential change in outcomes following the intervention. Participants will then take at least a 4-week break before returning to complete Baseline 2 testing and up 15 visits over 5 weeks of the alternative intervention before finally completing Post 2 testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinded clinical assessors will perform assessments of clinical outcomes.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral deficits following stroke > 6 months prior; however individuals > 4 months post-stroke are eligible for consenting, but final eligibility and potential enrollment will not occur until > 6 months
- •Age 18-85 years
- •Weight < 350 pounds
- •Able to follow a 3-step command
- •Able to ambulate with self-selected gait speeds between 0.01-1.0 m/s without physical assistance, but with below knee bracing and/or assistive device as needed
- •Lower extremity Fugl-Meyer < 34
- •Medical clearance to participate
排除标准
- •Evidence of cerebellar ataxia
- •Uncontrolled cardiopulmonary or metabolic disease that limits exercise participation, active heterotopic ossification, recurrent history of lower extremity fractures, previous orthopedic or other peripheral or central neurologic injury that may impair locomotor activities
- •Currently participating in other physical therapy
- •> 50 units of Botox in the lower extremity OR in the lower extremity, but above the knee if the participant wears an ankle-foot-orthosis (AFO) within the past three months. Note that participants may be consented prior to 3 months post-injection; however, eligibility will be determined post 3 months.
- •Unable to read > 50% of the letters on the 20/70 line of the Snellen Chart with customary eye wear at a distance of 20 feet
结局指标
主要结局
6 minute walk test
时间窗: After 5 weeks of training
Individuals will be asked to "cover as much ground as possible" over a six minute period.
Gait speed
时间窗: After 5 weeks of training
This is an assessment of overground walking speed measured across a distance of \~20 feet and will be conducted at both self-selected (instructions: "walk at your usual, comfortable pace") and fastest (instructions: "walk as fast as you safely can") walking speeds.
Peak treadmill speed
时间窗: After 5 weeks of training
Individuals will participate in a walking-based graded exercise test. While harnessed for safety on a treadmill, the treadmill will be initially set to 0.1 m/s and increased by 0.1 m/s each minute until the test is terminated due to one of the following: 1) the participant requests to stop, 2) the participant is unable to keep up with the speed of the treadmill and/or loses their balance, 3) any of the absolute exercise test termination criteria provided by American College of Sports Medicine are present. The highest speed that the individual can walk for a minute at is the peak treadmill speed.
次要结局
- Mini Balance Evaluation Systems Test(After 5 weeks of training)
- Medical Outcomes Survey Short-Form 36 (SF-36)(After 5 weeks of training)
- Oxygen Consumption(After 5 weeks of training)
- Steps per Day(After 5 weeks of training)
- Activity-Specific Balance Confidence (ABC) Scale(After 5 weeks of training)
- 30 second Sit to Stand Test(After 5 weeks of training)
研究者
Christopher Henderson
Assistant Research Professor
Indiana University