Action Observation Tele-rehabilitation for Upper Limb in Children With Diplegic Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 54
- 试验地点
- 6
- 主要终点
- Changes in the Both Hands Assessment (BoHA)
研究概览
简要总结
A new rehabilitative approach, called AOT, based on the discovery of mirror neuron system (MNS), has been used with promising results on the Upper Limb (UL) function in some studies in children with Cerebral Palsy (CP).
The purpose of the present trial is to provide evidence by an RCT, preceded by a pilot study, that customized and home based AOT training is an effective rehabilitation tool in children with diplegic CP (DCP) and that its effects are greater than standard care.
Both Hands Assessment (BoHA) is chosen as primary outcome measure and a sample size of 27 per group is required. The rehabilitation lasting 8 weeks will be provided at home by an ICT platform able to deliver, manage, monitor and measure a personalized AOT.
详细描述
A two-arm, evaluator-blinded, randomized trial (RCT), preceded by a pilot study, will be conducted according to CONSORT guidelines. Each participant will be randomized to either:
- Intervention group (Experimental group). Children will receive immediately the system for 8 weeks.
- Standard care group (Control group). Children will continue standard care At the end of the project, if the study results will be positive, children enrolled in the control group will be able to have the same treatment as the experimental group, if necessary.
The system will provide an in-home, individualized, intensive treatment based on the AOT. The system will be delivered at home and the children will perform a 60-minute training session at least 5 days a week for 8 consecutive weeks (total of 40 hours).
Follow-up assessment (outcome measures) will be conducted before (T0) and post-intervention at 1 weeks (T1), and then 8 and 24 weeks after the AOT intervention/standard care (T2 and T3).
The primary endpoint will be T1. Clinical assessments will be administered by a therapist blind to group assignment in each centre. Scoring of videotaped clinical outcome measures will be performed by therapists blind to group allocation and assessment order.
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)
入排标准
- 年龄范围
- 5 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of diplegic cerebral palsy (DCP) (GMFCS level I to IV - children may have been achieved an independent gait)
- •age between 5 and 16 years
- •MACS level I-IV
- •sufficient cooperation and communicative understanding to perform assessments and participate in the intervention
- •caregivers able to commit and collaborate in a rehabilitative intensive home
- •subjects and parents able to commit to the intensive rehabilitation program for a period of 8 weeks.
排除标准
- •Exclusion criteria will be uncontrolled seizures and UL botulinum injections or orthopaedic surgery in the previous 6 months or during the study period.
结局指标
主要结局
Changes in the Both Hands Assessment (BoHA)
时间窗: Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the training/control period); T2 (8 weeks after the end of the training/control period) and T3 (24 weeks after the end of the training/control period)
This assessment measures bimanual performance in children with bilateral CP, during a semi-structured session with specific toys or activities.
次要结局
- Changes in neuropsychological assessment (sensory-motor domain)(Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the training/control period); T3 (24 weeks after the end of the training/control period))
- Changes in Box and Block Test (BBT)(Baseline (T0, 1week before beginning of the study); T1 (within 1 week after the end of the training/control period); T2 (8 weeks after the end of the training/control period) and T3 (24 weeks after the end of the training/control period))
- Changes in BRIEF P(Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the training/control period); T3 (24 weeks after the end of the training/control period))
- Changes in ABILHAND-kids(Baseline (T0, 1week before beginning of the study); T1 (within 1 week after the end of the training/control period); T2 (8 weeks after the end of the training/control period) and T3 (24 weeks after the end of the training/control period))
- Changes in Cerebral Palsy Quality of Life Questionnaire for Children (CP QOL -Child, 4-12 years)(Baseline (T0) and T3 (24 weeks after the end of the training/control period))
- Feasibility questionnaire(T1 (within 1 week after the end of the training))
- Changes in Melbourne Assessment 2 (MA2)(Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the training/control period); T2 (8 weeks after the end of the training/control period) and T3 (24 weeks after the end of the training/control period))
- Changes in daily life activities detected with Actigraph GXT3+(During training and/or standard period (from T0 to T1) (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the training/control period))
- Changes in cognitive assessment(Baseline (T0, 1 week before beginning of the study))
- Changes in Canadian occupational performance measure (COPM)(Baseline (T0, 1week before beginning of the study); T1 (within 1 week after the end of the training/control period); T2 (8 weeks after the end of the training/control period) and T3 (24 weeks after the end of the training/control period))
- Changes in neuropsychological assessment (social perception domain)(Baseline (T0, 1 week before beginning of the study))
- Changes in BRIEF 2(Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the training/control period); T3 (24 weeks after the end of the training/control period))
- Changes in Participation and Environment Measure - Children and Youth (PEM-CY)(Baseline (T0) and T3 (16 weeks after T2))
- Changes in Cerebral Palsy Quality of Life Questionnaire for Adolescents (CP QOL -Teen, 13-18 years)(Baseline (T0) and T3 (24 weeks after the end of the training/control period))
- Changes in technological measurement of manual abilities by means of Virtual Reality Rehabilitation System (VRRS)(Baseline (T0, 1week before beginning of the study); T1 (within 1 week after the end of the training/control period); T2 (8 weeks after the end of the training/control period) and T3 (24 weeks after the end of the training/control period))
- Changes in technological measurement of manual abilities by means of Upper Limb TRAcker system (ULTRA +)(Baseline (T0, 1week before beginning of the study); T1 (within 1 week after the end of the training/control period); T2 (8 weeks after the end of the training/control period) and T3 (24 weeks after the end of the training/control period))
- Changes in cerebral plasticity with fMRI (Functional Magnetic Resonance Imaging)(Baseline (T0, 1week before beginning of the study); T1 (within 1 week after the end of the training/control period))
- Quantitative Changes in upper limbs activities detected with Actigraph GXT3+ during clinical assessment.(Baseline (T0, 1week before beginning of the study); T1 (within 1 week after the end of the training/control period); T2 (8 weeks after the end of the training/control period) and T3 (24 weeks after the end of the training/control period))