Enriched Environments for Stroke Rehabilitation; Pilot Study to Determine Appropriate Outcome Measures and Their Sensitivity to Different Training Protocols
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Post test Wolf Motor Function Test
研究概览
简要总结
Stroke contributes significantly to the incidence of disabilities, with upper limb (UL) motor impairment being especially prevalent. Animal studies suggest that post-stroke motor recovery is largely attributable to adaptive plasticity in brain motor areas. While some environmental training factors contributing to plastic mechanisms have been identified in animals, translation of this knowledge to the clinical setting is insufficient. Optimal recovery may be related to both external (e.g., feedback type) and internal factors (e.g., cognitive ability, motivation). Clinically feasible methods for training are needed. Use of enriched virtual environments (VEs) may provide a way to address these needs. Outcome measures that best reflect recovery need to be identified since this is an essential step to evaluate the effect of novel training programs for UL motor recovery in stroke.
The research question is which clinical and kinematic outcome measures best reflect motor performance recovery after a targeted upper limb treatment intervention. Aim 1 is to compare changes in outcome measures recorded before and after an upper limb intervention in stroke subjects to motor performance in healthy subjects. Aim 2 is to determine motor performance between-group differences sample size is based on knowledge of expected outcome measure mean score differences between groups. Hypothesis. 1: Specific clinical and kinematic outcome measures will be sensitive to within-group (pre-post intervention training) changes. Hypothesis. 2: Specific clinical and kinematic outcome measures will be sensitive to between-group (healthy vs. patients in enriched vs. conventional intervention groups. Sixteen chronic stroke survivors and 8 age- and sex-matched healthy controls will participate. Patients will be matched on cognitive and motor impairment levels and divided into two groups. Using an single subject (A-B-A) research design, kinematics during two pre-tests, 3 weeks apart, will be recorded for test-retest reliability. Stroke groups will practice varied upper limb reaching movements (15 45-minute sessions in 3 weeks) in environments providing different motivation/feedback levels. Pre- and post motor performance evaluations will be done with clinical tests and a Test Task with specific motor performance requirements. A Transfer Task will also be recorded. By comparing data analysis methods (3-Dimensional (3D) analysis of different markers or placements), the investigators will identify which kinematic outcome measures best reflect motor improvement in post-test and follow-up sessions (retention).
The expected results are identification of two primary and two secondary outcome measures that reflect upper limb motor recovery and can distinguish between motor recovery and compensation. The results will be used to design a randomized control trial to determine the efficacy of VE-based treatment on arm motor recovery. The goal is to determine how extrinsic (environmental) and intrinsic (personal) motivational factors affect motor learning in stroke survivors with cognitive and physical impairment. Knowledge gained can also be used for rehabilitation of other neurological and orthopedic pathologies.
详细描述
A. Scientific Background
Stroke is the third leading cause of death in Western countries and upper limb (UL) sensorimotor dysfunction contributes significantly to the incidence of physical disabilities and handicaps (Olsen 1990). One explanation for poor arm recovery is the focus on task accomplishment rather than performance quality. This may reinforce alterative (compensatory) movement strategies instead of encouraging the reappearance of pre-morbid movement patterns (recovery). Although the rehabilitative goal is recovery of function, whether this is achieved through true motor recovery or compensation is still under debate. Indeed, for some patients with severe impairment, compensation should be encouraged to maximize functional ability. Alternatively, for those with good prognosis, motor recovery is emphasized for several reasons. First, given appropriate training, recovery can continue well into the chronic stage of stroke (e.g., Michaelsen & Levin 2004). Second, while compensation may assist immediate performance, it may lead to longer-term problems such as pain and contracture (Ada et al. 1994; Levin 1997). Third, permitting compensations could encourage learned nonuse limiting the capacity for subsequent motor gains (Allred et al. 2005). While performance gains have been documented after repetitive training of isolated movements (e.g., Whitall et al. 2000), few studies have addressed whether patients can use explicit information to optimize motor skill acquisition and whether true behavioural recovery occurs. Points to consider in developing optimal training programs is that learning occurs when participants are motivated, practice a variety of related tasks and are given relevant feedback (Nudo & Friel 1999; Winstein et al. 1999). In addition, patients may not benefit from variable practice until missing motor elements are recovered (Carr & Shepherd 1987) and motor relearning is related to physical and cognitive impairment level (Cirstea et al. 2006).
To date, most studies have used only clinical measures to evaluate functional change (e.g., Jang et al. 2003) without considering how movement is performed. This study will focus on the ability to distinguish between whether functional improvement results from an increase in compensation or from true motor recovery. This can only be done by correlating functional improvement (clinical measures) with changes in arm motor patterns through detailed movement analysis (kinematics). Since there are a large number of possible kinematic indicators of improvement, the investigators need to identify which measures are most indicative of change. This is a first step in the determination of clinically meaningful outcome measures to be used in randomized control trials of the effectiveness of interventions. Clinical salience is essential to translate knowledge from research studies to evidence-based practice (van Peppen et al. 2007).
B. Study Design: 1. Detailed Plan of the Study
Two groups of 8 stroke subjects will participate in an A-B-A design in which data from post-intervention (within one week of the completion of the intervention) and follow-up (one month after the completion of the intervention)tests will be compared to data from two pre-tests (held at beginning and end of the first week of the study just prior to the start of the intervention). Multiple clinical and kinematic motor performance outcomes will be measured to determine which ones best describe arm motor recovery. This will be done by comparing changes in outcomes before and after training to mean scores of 8 age- and gender-matched healthy volunteers (recorded in a single session). Stroke survivors will practice movement in two different training environments providing different levels of motivation and feedback: Training Environment 1 will be created in a 2D video-based VR environment that will provide high motivation, Knowledge of Results (KR) about motor outcome (i.e., speed, precision) and non-specific Knowledge of Performance (KP) feedback about trunk movement. Environment 2 will be created in a physical environment that provides only KP feedback but no KR or additional motivation.
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
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for patients wth stroke:
- •Age 40-80 years
- •sustained a single stroke between 3-24 months prio t study leading to upper limb paresis
- •have at least Stage 3/7 arm control (mild to moderate motor deficits) on the Chedoke-McMaster Scale.
- •<81 yrs old to minimize confounding effects of age-related changes in sensorimotor functions
排除标准
- •for patients wth stroke:
- •other neurological or orthopaedic problems that may interfere with interpretation of results
- •significant deficits in attention, constructional skills, neglect and apraxia
- •shoulder subluxation, arm pain
- •lack of endurance as judged by a physician
- •undergoing other therapy, surgery or medical procedures within the study period.
- •Inclusion Criteria for healthy control subjects:
- •Age 40-80 years
- •Exclusion Criteria for control subjects:
- •any neurological or orthopaedic problems that may interfere with interpretation of results.
研究组 & 干预措施
Conventional intervention for upper limb reaching
Reaching or holding cones, cups, etc. in all planes with and without gravity or loading
干预措施: conventional occupational therapy (Other)
VR treatment
The Virtual Reality (VR) therapy group received the treatment in the GestureTek VR environment which focused on reaching movements of the affected upper limb using virtual games and a virtual supermarket.
干预措施: video capture virtual reality (Device)
结局指标
主要结局
Post test Wolf Motor Function Test
时间窗: Change from baseline after 3 week treatment intervention
Wolf Motor Function Test (WMFT; Wolf et al., 1989) assessed upper limb motor function (quality and speed) on 15 functional tasks scored on 6-point (0-5) scales as well as 2 strength (grip strength and resistance while lifting or moving weighted objects) measures (Wolf et al., 2001). The tasks are arranged in order of increasing complexity and progress from proximal to distal joint involvement. The WMFT has high interrater (Interclass Correlation Coefficient =0.97-0.99), as well as test-retest reliability (0.90 for performance time and 0.95 for performance quality).
Follow-up Wolf Motor Function Test
时间窗: Change from baseline 4 weeks after end of treatment intervention
Wolf Motor Function Test (WMFT; Wolf et al., 1989) assessed upper limb motor function (quality and speed) on 15 functional tasks scored on 6-point (0-5) scales as well as 2 strength (grip strength and resistance while lifting or moving weighted objects) measures (Wolf et al., 2001). The tasks are arranged in order of increasing complexity and progress from proximal to distal joint involvement. The WMFT has high interrater (Interclass Correlation Coefficient =0.97-0.99), as well as test-retest reliability (0.90 for performance time and 0.95 for performance quality).
次要结局
- Post test Fugl-Meyer Arm Scale(Change from baseline after 3 week treatment intervention)
- Post test Composite Spasticity Index(Change from baseline after 3 week treatment intervention)
- Post test Reaching Performance Scale(Change from baseline after 3 week treatment intervention)
- Post test Box and Blocks Test(Change from baseline after 3 week treatment intervention)
- Post test Motor Activity Log(Change from baseline after 3 week treatment intervention)
- upper limb kinematics(One week before start of intervention)
- Follow-up Fugl-Meyer Arm Scale(Change from baseline 4 weeks after end of treatment intervention)
- Follow-up Composite Spasticity Index(Change from baseline 4 weeks after end of treatment intervention)
- Follow-up Reaching Performance Scale(Change from baseline 4 weeks after end of treatment intervention)
- Follow-up Box and Blocks Test(Change from baseline 4 weeks after end of treatment intervention)
- Follow-up Motor Activity Log(Change from baseline 4 weeks after end of treatment intervention)
