Functional Electrical Stimulation to Improve Upper Extremity Function in Young Children With Perinatal Stroke: A Proof of Concept Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Change in Melbourne Assessment 2 score
研究概览
简要总结
Every year about 1 out of every 1,600-5,000 infants has a stroke around the time of birth. Many of these children will have lifelong physical problems. For example, the arm muscles are often paralyzed. This makes every day activities, like reaching and grasping objects, very difficult. To date there are few effective treatments for the paralyzed arm of young children with stroke. The main objective of this study is to test whether a new kind of treatment, known as functional electrical stimulation (FES), is able to improve arm function in children with stroke. FES involves applying electrical currents to weak or paralyzed muscles. This enables movements, such as reaching and grasping, which can then be practiced. The investigators will compare the effectiveness of FES treatment to standard arm rehabilitation in children aged 3-6 years who had a stroke early in life. They will measure the effectiveness using a number of clinical measures of arm function. Other objectives of this project are to test how well children adhere to the treatment schedule, and to evaluate parent and child satisfaction with FES treatment.
详细描述
Primary Objective: To compare the change in upper extremity (UE) function between two interventions for young children with a history of perinatal stroke: FES UE training and dose-matched, conventional UE training.
Our secondary objective was to evaluate the feasibility of FES for the upper limb in young children with a history of perinatal stroke by comparing between interventions the 1) adherence to the prescribed dosage and 2) intensity of training, quantified through an accelerometer-based measurement of affected arm movement.
This is a proof-of-concept, mixed methods, pilot study that will use a single-blind, randomized clinical trial design. The study will involve two sites: the University of Alberta in Edmonton, and the Toronto Rehabilitation Institute - University Health Network. The total study duration is three years, while the time commitment of each child is about 9 months. Participants will complete two baseline assessments spaced 1-2 weeks apart, and will then be randomized into one of two groups (FES treatment or conventional UE training). The treatment period will last 12 weeks, and will be followed by a 6 month follow-up period.
Participants Twenty-four children (12 per treatment group) will participate. To reach the target of 24 children, a total of 30 children with perinatal stroke will be recruited. This allows for 20% attrition. As this is a pilot study, the sample size is based on a conservative estimate of the number of children the investigators anticipate being able to recruit and enroll over a three year period in the two participating cities.
Participants will be recruited through numerous means, including two main clinical sites: the Glenrose Rehabilitation Hospital (Edmonton) and the Holland Bloorview Kids Rehabilitation Hospital (Toronto). Following recruitment, potential participants will be screened through a telephone interview by the Research Coordinator.
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
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be aged 3-6 years
- •have experienced a unilateral perinatal stroke
- •show focal brain injury on an MRI
- •be rated a level II, III or IV on the Manual Ability Classification System by a physical or occupational therapist (this a 5-point ordinal scale with levels II, III and IV described as "Handles most objects but with somewhat reduced quality and/or speed of achievement", "Handles objects with difficulty; needs help to prepare and/or modify activities" and "Handles a limited selection of easily managed objects in adapted situations", respectively)
- •be able to maintain an unsupported sitting position for >5 minutes.
排除标准
- •any other disease, injury or condition that affects their UE motor function
- •contractures of the hand, wrist or elbow
- •an implanted electronic device
- •peripheral nerve damage in the affected UE
- •surgical hardware in the UE
- •a history of epilepsy
- •a skin rash or wound at a potential electrode site
- •received an injection of botulinum toxin to the UE within the past 6 months. Children entered into the study may be withdrawn at some point during the study if their skin is irritated by the FES treatment
- •they begin a new physical or pharmacological intervention during the treatment period of the study, and it affects UE function.
研究组 & 干预措施
FES
Unilateral and bimanual activities are performed with FES applied to the hemiparetic arm.
干预措施: FES (Device)
Conventional
Unilateral and bimanual activities are performed with no FES applied to the hemiparetic arm.
干预措施: Conventional (Behavioral)
结局指标
主要结局
Change in Melbourne Assessment 2 score
时间窗: 2 baseline assessments, after 18 treatment sessions, after 36 treatment sessions, 6 weeks post-treatment, 12 weeks post-treatment, 6 months post-treatment
The Melbourne Assessment 2 (MA2) evolved from the original Melbourne Assessment of Unilateral Upper Limb Function. It assesses the quality of arm movement in children as young as two years of age. It consists of four subscales (range of motion, dexterity, accuracy, and fluency) and involves performing 14 tasks, such as reaching, grasping and manipulating objects. It is scored from a video recording or live observation of a child playing with standardized objects. The MA2 is valid, and has high interrater reliability and good test-retest reliability in children with neurological conditions. Published standard error of measurement values for the raw Melbourne scores were used to calculate the minimally important difference for each subscale. Calculated MID values were as follows: range of motion = 4, accuracy = 4, dexterity = 2, and fluency = 4.
Change in Melbourne Assessment 2 score
时间窗: From enrollment to 6 months post-treatment
The Melbourne Assessment 2 (MA2) evolved from the original Melbourne Assessment of Unilateral Upper Limb Function. It assesses the quality of arm movement in children as young as two years of age. It consists of four subscales (range of motion, dexterity, accuracy, and fluency) and involves performing 14 tasks, such as reaching, grasping and manipulating objects. It is scored from a video recording or live observation of a child playing with standardized objects. The MA2 is valid, and has high interrater reliability and good test-retest reliability in children with neurological conditions. Published standard error of measurement values for the raw Melbourne scores were used to calculate the minimally important difference for each subscale. Calculated MID values were as follows: range of motion = 4, accuracy = 4, dexterity = 2, and fluency = 4.
Change in Assisting Hand Assessment score
时间窗: From enrollment to 6 months post-treatment
The Assisting Hand Assessment (AHA) was designed for use in children with a hemiplegic arm aged 18 months - 5 years. It measures how well children use their affected arm in bimanual activities, such as spontaneous handling of toys during play. Like the MA2, the AHA is routinely scored from a video recording. The validity, reliability and responsiveness of the AHA has been demonstrated in children with hemiplegic cerebral palsy. Raw AHA scores will be converted to a logit-based 0-100 scale in AHA units. Five AHA units represent the smallest detectable change.
次要结局
- Change in Modified Tardieu Scale score(2 baseline assessments, after 18 treatment sessions, after 36 treatment sessions, 6 weeks post-treatment, 12 weeks post-treatment, 6 months post-treatment)
- Change in quantity of arm movement in daily life (accelerometry)(2 baseline assessments, after 18 treatment sessions, after 36 treatment sessions, 6 weeks post-treatment, 12 weeks post-treatment, 6 months post-treatment)
- Change in Assisting Hand Assessment score(2 baseline assessments, after 18 treatment sessions, after 36 treatment sessions, 6 weeks post-treatment, 12 weeks post-treatment, 6 months post-treatment)
- Change in Modified Tardieu Scale score(From enrollment to 6 months post-treatment)
- Change in quantity of arm movement in daily life (accelerometry)(From enrollment to 6 months post-treatment)
- Adherence(From the start to the end of the 12-week intervention)