FES in Young Children With Perinatal Stroke (NCT02975180) | Clinical Trial Compass
CompletedNot Applicable
FES in Young Children With Perinatal Stroke
Canada11 participantsStarted 2018-01-01
Plain-language 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.
Who can participate
Age range3 Years – 6 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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
What they're measuring
1
Change in Melbourne Assessment 2 score
Timeframe: From enrollment to 6 months post-treatment
2
Change in Assisting Hand Assessment score
Timeframe: From enrollment to 6 months post-treatment
✕. 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