Movement Impairment Characterization and Rehabilitation for Spastic/Dystonic Cerebral Palsy Using Robotic Haptic Feedback in Virtual Reality
试验速览
- 阶段
- 不适用
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Smoothness Index
研究概览
简要总结
This game-like intervention using virtual reality will provide an objective and quantitative characterization of dystonia and spasticity presentations in cerebral palsy, even if combined, through the process of motor learning. This intervention could have a therapeutic benefit in the rehabilitation of children with cerebral palsy.
详细描述
Cerebral palsy is the most common developmental motor disorder in children. Individuals with cerebral palsy demonstrate abnormal muscle tone and motor control. Within the population of children with cerebral palsy, between 4% and 17% present dystonic symptoms and between 80% to 95% of cases present spasticity. In many cases spasticity and dystonia are present in the same child and accurate diagnosis may be challenging.
This study consists of a randomized controlled trial that uses a virtual reality game-based intervention incorporating fully-automated robotic haptic feedback to aid the the objective, quantitative diagnosis of spasticity and dystonia u=in CP. The study consists of face-to-face assessments of movement before, after, and one-month following the completion of the six-session game-based intervention. Children with spastic/dystonic cerebral palsy and typically developing children between the ages of 7 and 17 will be recruited for this study. The investigators anticipate to recruit a total of 68 participants, 34 with cerebral palsy and 34 typically developing. Both groups of children will be randomly allocated into an intervention or control group using a blocked randomization method. Movement outcomes will be examined for changes in quantitative and clinical measures in children with spastic/dystonic cerebral palsy and typically developing children to aid on the classification of movement disorders. Pair t-tests will be conducted on movement outcomes for both groups of children independently. Positive and negative results will be reported and addressed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
Research team members administering clinical assessments will be blinded from participant allocation. Participant's allocation will not be revealed during the course of the study.
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between ages 7 and 17
- •Have been diagnosed with dystonic or spastic/dystonic cerebral palsy, for the cerebral palsy groups, or have no neuromuscular conditions, for typically developing groups
- •Have mild to no difficulty understanding conversations compared to others of the same age
- •Communicates age appropriately or with some difficulty but a new listener can understand
- •Have no uncorrected vision
- •Have hearing without the need of a hearing aid
- •Have no other neural, neuromuscular, or musculoskeletal conditions
- •Participation in stable school and/or private physical or occupational therapy with a frequency no greater than two sessions per week, for cerebral palsy groups
- •Have no changes in medication for the six months previous to enrollment in the study
- •Be medically stable
- •Have no other concurrent illness
- •Have not received any Botox treatment within three months previous to the initiation of the study
- •No use of cardiac pacemakers, hearing aids, or another electronic implanted device
- •Absence of allergy to silver or skin adhesives
- •Have never had seizures
- •Have Manual Ability Classification System (MACS) score I-III
排除标准
- •Not meeting ALL inclusion criteria
结局指标
主要结局
Smoothness Index
时间窗: Tested during the assessment sessions spanning over a 6 to 7 week period.
The smoothness index will be measured by analyzing the the integrated accelerometry signals of sensors placed on the upper limbs. Accelerometry data will be integrated to calculate the smoothness index on the velocity profile of the trajectories. The maximum value is 0, being the greatest level of smoothness that can be measured, and the minimum is minus infinity. A value closer to 0 is desired.
次要结局
- Dyskinesia Impairment Scale (DIS)(Tested during the assessment sessions spanning over a 6 to 7 week period.)
- Selective Control of the Upper Extremity Scale (SCUES)(Tested during the assessment sessions spanning over a 6 to 7 week period.)
- Quality of Upper Extremity Skills Test (QUEST)(Tested during the assessment sessions spanning over a 6 to 7 week period.)
- Tardieu scale(Tested during the assessment sessions spanning over a 6 to 7 week period.)
- World Health Organization Disability Assessment Schedule 2 Children and Youth (WHODAS II - CY)(Tested during the assessment sessions spanning over a 6 to 7 week period.)
- Surface electromyography(Tested during the assessment sessions and on the first and last day of gameplay spanning over a 6 to 7 week period.)
- Forces and torques against force sensor during gampeplay and in robotic zero-force channel(Tested during the assessment sessions and on the first and last day of gameplay spanning over a 6 to 7 week period.)
- Montreal Spasticity Rating Test (MSRT)(Tested during the assessment sessions spanning over a 6 to 7 week period.)
- Qualitative Feedback Module(Tested during the assessment sessions spanning over a 6 to 7 week period.)
研究者
Citlali Lopez-Ortiz
Assistant Professor
University of Illinois at Urbana-Champaign