Clinical Trial: FES in Young Children With Perinatal Stroke

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Functional Electrical Stimulation to Improve Upper Extremity Function in Young Children With Perinatal Stroke: A Proof of Concept Study

Brief Summary: 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.

Detailed Summary:

Primary Aim: To compare, in young children with perinatal stroke, the change in UE function between two treatment approaches: 1) FES treatment, and 2) conventional UE training.

Secondary Aim 1: To compare the intensity (i.e., number of repetitions performed per treatment session) between FES treatment and conventional UE training.

Secondary Aim 2: To compare adherence to the two treatment methods (FES treatment and conventional training).

Secondary Aim 3: To evaluate parent and child satisfaction with FES treatment.

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
Sponsor: University Health Network, Toronto

Current Primary Outcome: Change in Melbourne Assessment 2 score [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in Assisting Hand Assessment score [ Time Frame: 2 baseline assessments, after 18 treatment sessions, after 36 treatment sessions, 6 weeks post-treatment, 12 weeks post-treatment, 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.
  • Change in Modified Tardieu Scale score [ Time Frame: 2 baseline assessments, after 18 treatment sessions, after 36 treatment sessions, 6 weeks post-treatment, 12 weeks post-treatment, 6 months post-treatment ]
    The Modified Tardieu Scale is a measure of spasticity that considers resistance to passive stretch of a muscle at slow and fast speeds. This scale has been used in children with cerebral palsy as young as 3 years of age, and has adequate interrater reliability in this population. To perform this assessment, the child's affected elbow and wrist will be passively moved through the available range of motion at slow and fast speeds. The angle of the 'catch' in the passive joint movement (i.e., R1), and the full passive range of motion (i.e., R2) will be noted. For this measure, a researcher will secure electrogoniometers over the affected elbow and wrist, and place electromyography recording electrodes over the triceps, biceps, wrist extensors and wrist flexors on the affected side. We expect this to increase the robustness of this clinical measure in children, and have previously found this instrumented approach to be useful.
  • Change in quantity of arm movement in daily life (accelerometry) [ Time Frame: 2 baseline assessments, after 18 treatment sessions, after 36 treatment sessions, 6 weeks post-treatment, 12 weeks post-treatment, 6 months post-treatment ]
    Accelerometry will be used to assess UE movement in daily life. Participants will be asked to wear a wGT3X-BT wireless activity monitor (Actigraph) on each wrist for seven consecutive days, with the aim of achieving a total of 24 hours of wear time (monitor removed during treatment sessions). Accelerometry is a valid method of assessing UE activity in adults with stroke and a MSc student in Dr. Musselman's lab is currently validating the tool in children with hemiparesis. Raw activity counts for the two arms will be collected, and the ratio of impaired to unimpaired UE activity will be calculated.


Original Secondary Outcome: Same as current

Information By: University Health Network, Toronto

Dates:
Date Received: November 3, 2016
Date Started: January 2017
Date Completion: December 2019
Last Updated: November 22, 2016
Last Verified: November 2016