Infant Modified Constraint Induced Movement Therapy Paired With Neuromuscular Electrical Stimulation: a Case Series
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Change in hand use based on the Hand Assessment of Infants
研究概览
简要总结
This study will compare the motor outcomes for five infants with asymmetrical hand function (AHF) who will receive two, three week episodes of standard care separated by a three week episode of mCIMT paired with Neuromuscular Electrical Stimulation. The results of this study will inform decisions on the feasibility and efficacy of the treatment for use in a larger study for infants with AHF at risk for unilateral cerebral palsy.
详细描述
Infants with asymmetrical hand function will participate in three consecutive phases of treatment.
The first and third phase will consist of three weeks of standard care for children with asymmetrical hand function, 1 hour/day, 1 day/week. The therapist will provide weekly coaching with the parents so they can carry over activities at home one hour/day, six days/week during this phase. In addition, a sock or mitten will be used for short term constraint during the hour of training both in the clinic with the therapist and at home with the parent.
The second phase will consist of three weeks of modified constraint induced movement therapy, 2 hours/day, 3 days/week paired with NMES, 15 minutes/day, 3 days/week. The infants will wear a soft splint on their preferred hand and forearm 24 hours/day during this phase. Parents will be trained by the therapist to carry over activities with their child at home, 1 hour/day, 6 days/week.
The children will return at chronological age of 18 months for follow up testing.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 7 Months 至 10 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infant is 7-10 months of age (CCA)
- •Clinical presentation of asymmetrical hand function,
- •Grade 2/5 movement in more impaired upper extremity,
- •Demonstrate potential to participate in 6 hours of therapy/week during 3 week episode of mCIMT-NMES, as determined by principal investigator,
- •Parent/guardian willing to be partners in study and participate in follow-up assessments until child is 18 months of age
排除标准
- •Medical or sensory condition that prevents full therapy participation (active seizures, significant visual impairment)
- •Received Botox injection to more impaired upper extremity within last 6 months,
- •NMES contraindicated (impaired skin integrity, presence of pacemaker, clotting disorder),
- •Previous UE surgery or nerve injury (brachial plexus)
结局指标
主要结局
Change in hand use based on the Hand Assessment of Infants
时间窗: Baseline, week 4, week 7, week 10
A criterion, norm referenced assessment that evaluates and measures goal directed both hand use and possible upper limb asymmetry in infants at risk of developing cerebral palsy,aged 3-12 months.
次要结局
- Change in motor skills based on the Peabody Developmental Motor Scales-2(Baseline, week 4, week 7, week 10, 18 months CCA)
- Assisting Hand Assessment Version 4.4(18 months CCA)
研究者
Kathy Grinde
Physical Therapist, Rehab Clinical Specialist
Children's Hospitals and Clinics of Minnesota