Functional Engagement in Assisted Therapy Through Exercise Robotics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Wolf Motor Function Test WMFT
研究概览
简要总结
The investigators have assembled an integrated knowledge/technology/client team to develop a novel motion capture-based home therapy program for children with hemiparesis (cerebral palsy, acquired brain injury (ABI)) and older persons post-stroke. The investigators society needs new approaches to improve the quality of life for millions of Canadians. The method proposaed here is to combine low-cost motion capture devices, a bimanual training program, social media frameworks such as Facebook Games, and on-line performance sharing between therapy clients and with their therapists. The investigators believe that together these approaches will yield interventions for people with stroke and children with hemiplegia that significantly improve their motivation to continue their exercise programs and thus improve their functional ability which will lead to improved quality of life.
详细描述
A) Purpose:
The similarity of functional impairments in the two target hemiplegic populations, teenagers with hemiparetic cerebral palsy CP or acquired brain injury (post-acute phase) and hemiparetic stroke survivors, leads us to pursue a unified rehabilitation strategy. Although age-dependency is clearly a factor in rate of motor learning, intensive therapies have shown similar returns of function with similar intensities and length of treatment across different populations [1]. By involving both adults and children in the same study, the investigators can directly compare the effects of identical interventions using the innovative hardware and software solutions that are developed.
The team of investigators have developed a system that includes a camera (PS3 Eye), 2 modified PS3 Move controllers, and a computer [2]. A software is designed to search through the camera feed to find the glowing balls attached to the two PS3 Move controllers, and changes the position of the computer's mouse cursor based on the position of the two glowing balls. This allows the participants to play simple 2D Facebook games that involve point-and-click by holding on to the Move controllers and moving their arms in space in order to control the cursor and play games.
B) Hypothesis:
The investigators hypothesize that the following strategies will deliver effective, long-term therapy: (1) use a bimanual approach, based on recent research that shows the powerful integrative value of involving both limbs and both cerebral hemispheres in recovery of function post-stroke [3]; (2) target hand-function, following the proven efficacy of this approach (CIMT and GRASP) over exercising arm motions only; (3) directly target patient motivation by embedding the therapy in a social construct of multi-user online gaming such as Facebook Games [4, 5].
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion for adolescents:
- •Ages 13-18 years
- •Hemiplegia
- •Gross Motor Functional Classification System (GMFCS) Level 1-4
- •Manual Ability Classification System (MACS) Level 1-3
- •Grade 2+ bilateral shoulder flexors (ability to lift arms against gravity at least some distance)
- •The ability to follow instructions and answer questions in English (as determined by referring therapist and caregiver)
- •Not had orthopedic surgery in the past 6 months
- •Inclusion for Adults with Stroke:
- •Hemiplegia as a result of a cerebral stroke (ischemic or hemorrhagic)
- •0 - 3 Modified Ashworth Scale
- •>Grade 2+ bilateral shoulder flexors (ability to lift arms against gravity at least some distance)
- •The ability to follow instructions and answer questions in English (as determined by referring therapist)
- •Folstein mini - mental state test result >24 points
- •Not had orthopedic surgery in the past 6 months
- •This will be extended to include patients with active shoulder flexion using gravity-assist.
排除标准
- •Exclusion for adolescents with hemiplegia:
- •Predominant dystonia or muscle contracture (Modified Ashworth Scale <3)
- •Upper limb orthopedic surgery in the past six months
- •Cognitive impairment: <23 on the Mini Mental Status Exam (MMSE)
- •Receiving other therapy for upper extremity functional outcomes.
- •Exclusion for Adults with Stroke:
- •Predominant dystonia or muscle contracture (Modified Ashworth Scale >3)
- •Cognitive impairment: <23 on the Mini Mental Status Exam (MMSE)
- •Upper limb orthopedic surgery in the past 6 months
- •Receiving other therapy for upper extremity functional outcomes.
结局指标
主要结局
Wolf Motor Function Test WMFT
时间窗: every 2 month, from date of randomization (month 0) to the end of the study (end of month 6)
For early intervention group: administer at enrollment in the study (baseline), at the end of FEATHERS intervention (end of week 8, assessing changes due to intervention), at the end of week 16 (no intervention period, retention), at the end of week 24 (no intervention period, assessing variation of the outcomes even without a therapy intervention). For late intervention group: administer at enrollment in the study (baseline), at the end of week 8 (no intervention period, assessing variation of the outcomes even without a therapy intervention), at the end of FEATHERS intervention (end of week 16, assessing changes due to intervention), at the end of week 24 (no intervention period, retention). Administer for all participants.
次要结局
- Motricity index, grip/pinch index(every 2 month, from date of randomization (month 0) to the end of the study (end of month 6))
- Canadian Occupational Performance Measure COPM(every 2 month, from date of randomization (month 0) to the end of the study (end of month 6))
- Modified Rankin Test(one time only, at the beginning of the study)
- Confidence scale(one time only, at the beginning of FEAHTERS intervention)
- Paediatric Motivation Scale(every 2 weeks (during the 2 months of FEATHERS intervention))
- Usability of the System(one time only, at the end of FEATHERS intervention)
- Reach Performance Scale(every 2 month, from date of randomization (month 0) to the end of the study (end of month 6))
- Game-based kinematic test(every 2 weeks (during the 2 months of FEATHERS intervention))
研究者
Hendrik F. Machiel Van der Loos
Associate Professor
University of British Columbia