Efficacy of Constraint Induced Movement Therapy Delivered by Tele-Video for Children With Hemiplegic Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Melbourne Assessment of Unilateral Upper Limb Function
研究概览
简要总结
The CHAMP-T2 study is a pilot test of the efficacy of constraint induced movement therapy (CIMT) when delivered by tele-video in the child's home or home-like environment. This study will examine the pre-, post-intervention function a hemiparetic limb in children who have hemiplegic cerebral palsy. The purpose is to provide an effect size estimate that will inform the design of a future study that will compare tele-delivered CIMT with usual and customary care.
详细描述
The CHAMP-T2 study is a pilot study of the efficacy of constraint induced movement therapy (CIMT) when delivered by tele-video in the child's home or home-like environment. This study will examine the pre-, post-intervention function of the paretic limb in children who have hemiplegic cerebral palsy. The purpose is to develop an effect size estimate that will inform the design of a future study that will compare tele-delivered CIMT with usual and customary care.
Primary Aim: To determine the effect of tele-delivered CIMT (CHAMP-T protocol) upon upper extremity (UE) motor function in school-aged children with post-stroke hemiparesis. The hypothesis is that the motor function of the paretic UE will improve significantly following tele-delivered CIMT.
The primary outcome will be the change in function of the impaired upper limb as measured by the Melbourne Assessment of Unilateral Upper Limb Function (MAUULF) (16) The secondary outcome will be the use of the affected limb in bilateral function as assessed with the Assisting Hand Assessment (AHA),(17) a well-established measure of an impaired upper limb in bilateral activities that is validated in children ages 18 months to 18 years. The parents will report their observation of the function of the affected limb also at baseline and at the end of the 4-week intervention. The reporting will use the Pediatric Motor Activity Log (PMAL),(18) which is a published, validated measure that was included in the study team's prior studies.(1) Fidelity to the treatment protocol will be assessed by parents' logs of the number of hours of treatment intervention the child undergoes, the recorded hours that the child wears the splint, and review of the recorded video sessions. Parent-therapist communication will be assessed by the Parent-Therapist information exchange tool. Factors affecting treatment delivery, including obstacles and barriers to task performance as well as supports that might assist performance in a larger clinical trial will be evaluated through semi-structured interviews and observations of treatment sessions with the parent and the treating therapist.
There will be a pre- and post-intervention assessment of the effect of tele-delivered CIMT delivered for 60 hrs over 4 weeks upon motor function of the paretic UE. After informed consent is obtained families will be asked to provide details regarding the child's medical history and diagnoses, previous treatments for cerebral palsy, and will be assessed for cerebral palsy severity.
The study will treat 10 children with hemiplegic cerebral palsy with the CHAMP-T2 protocol. Five families will be trained in- person by the therapists regarding basic principles of CIMT and how to use the televideo ensemble. Five families will receive the same training virtually. The CHAMP-T2 version of CIMT will be delivered 3 hours per day, 5 days per week, for 4 weeks by tele-delivery in the subject's home. The therapist will work with the parent by tele-video for 2 of the 3 hours to deliver the CIMT. The parent will work directly with the child without the therapist for a 3rd hour of each session. The children will wear the immobilization splint continuously each day up to 90% of the waking hours during the CIMT intervention period of 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children who have hemiplegic cerebral palsy, ages 4-10;
- •hemiparesis ranging from Manual Ability Classification System (MACS) I to MACS IV;
- •live within a 1.5 hour distance from therapists' worksites at the Ohio State University Wexner Medical Center in Columbus, Ohio, or the Fralin Biomedical Research Institute in Roanoke, Virginia;
- •are willing to travel to these sites for two in-person assessments.
排除标准
- •Previous high dose CIMT (defined as CIMT given 2 hrs per day for 10 days) in the 6 months preceding baseline assessment;
- •Treatment with botulinum toxin for spasticity in the 3 months preceding baseline assessment;
- •Surgery for spasticity in the 6 months preceding baseline assessment;
- •Medically unstable and unable to participate in the treatment intervention;
- •Child is behaviorally or cognitively impaired so unable to participate in the treatment intervention;
- •Family unable to participate in tele-delivery of CIMT 5 days a week for 4 weeks;
- •the caregiver available at child's treatment site during treatment times is unable to communicate with the treating therapist.
结局指标
主要结局
Melbourne Assessment of Unilateral Upper Limb Function
时间窗: At baseline pre-treatment and at the end of the 4-week intervention
Measures function of the impaired upper limb
次要结局
- Assisting Hand Assessment(At baseline pre-treatment and at the end of the 4-week intervention)
- Pediatric Motor Activity Log(At baseline pre-treatment and at the end of the 4-week intervention)
- Fidelity to treatment protocol(During 4 weeks of intervention)
研究者
Warren Lo
Clinical Professor, Pediatrics and Neurology
Nationwide Children's Hospital