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 range
3 Years – 6 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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