Parent Therapist Partnership to Provide Early, Intensive Exercise to Enhance Walking Outcomes in Children With Perinatal Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- Gross Motor Function Measure (GMFM-66) - change from baseline
研究概览
简要总结
A prospective, single blind, parallel group, randomized control trial to determine if early, intensive lower extremity activity delivered by a physical therapist and a parent in partnership improves gross motor function more than usual care.
详细描述
A mixed-methods randomized controlled trial at 3 healthcare centres: Edmonton, Calgary and Ottawa. The period of participation for each child is 12 months. The Immediate Group will have 3 months of intervention and 9 months follow-up. The Delay Group will be followed for 6 months (waitlist-control period), then given the opportunity to receive the same intervention and followed for 3 months after the intervention.
The intervention will be delivered by clinicians in the rehabilitation centres in partnership with the child's parents. Therapists will provide training 2 days a week and will coach the parents to provide the training at home for 2 days a week.
The intervention is ELEVATE (Engaging the Lower Extremity Via Active Therapy Early) and consists of child-initiated, intensive leg activities for one hour a day, four days a week for 12 weeks.
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 (Outcomes Assessor)
盲法说明
Assessing therapists are masked to the child's group assignment.
入排标准
- 年龄范围
- 8 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children ages 8 months to 3 years
- •medical history and physical exam consistent with perinatal stroke
- •hemiparesis in the upper and/or lower extremity
- •parental agreement to adhere to the training and testing schedule
排除标准
- •bilateral motor impairment
- •epileptic seizures that could interfere with training
- •cognitive, behavioural or developmental impairments that preclude participation in the protocol
- •botulinum toxin A injections or surgery in the lower extremities within the previous six months
- •concurrent casting during the intervention phase (including constraint-induced movement therapy with casting)
- •diagnosis associated with neurological/developmental regression
- •parent unable to communicate (verbal and written) in English or French
研究组 & 干预措施
Immediate Group
The intervention is intensive exercise, delivered over 12 weeks beginning on admission to the study. The group will then be followed for 9 months post intervention.
干预措施: Intensive exercise (Behavioral)
Delay Group
The group will be followed for 6 months with no intervention. After 6 months the group will be given the opportunity to receive the same intensive exercise intervention as the Immediate group. The group will be followed for 3 months following the intervention.
结局指标
主要结局
Gross Motor Function Measure (GMFM-66) - change from baseline
时间窗: 3 months, 6 months, 9 months, 12 months
A 66 item criterion referenced observational measure of gross motor skills designed for children with cerebral palsy.
次要结局
- Young Children's Participation and Environment Measure (YC-PEM) - change from baseline(3 months, 6 months, 9 months, 12 months)
- Ankle joint angle at onset of stretch reflex - change from baseline(3 months, 6 months, 9 months, 12 months)
- Ankle joint angle at full dorsiflexion - change from baseline(3 months, 6 months, 9 months, 12 months)
- Resource use questionnaire(12 months)
- The Pediatric Quality of Life Measure module for cerebral palsy (PedsQL CP) - change from baseline(3 months, 6 months, 9 months, 12 months)