Functional Electrical Stimulation (FES) for Upper Extremity Hemiplegia in Children With Cerebral Palsy
Cerebral Palsy
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring cerebral palsy, hemiplegia, fes, grasping
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of hemiplegic CP
- Age between 6 to 18 years
- Ability to cooperate, understand and follow instructions during the administration of FES paired with intensive hand therapy
- Baseline total QUEST score between 20-80 out of 100 points
- Be seizure-free for a required period of at least 1 year with or without medication , and have no prior history of known cardiac arrhythmias/stimulants
- No pacemaker or implanted metallic or electronic device
- No edema, skin rash, allergy or wound on the affected upper limb where FES will be administered.
- No Botulinum toxin upper limb injections within 6-months of study entry, and no Constraint-induced movement therapy (CIMT) within 4 months of study entry. Participants should also refrain from receiving these treatments throughout the duration of the study.
Exclusion Criteria:
- The participant's forearm is too small to accommodate the standard FES electrodes.
The participant's muscles do not respond to the electrical stimulation as tested at the baseline assessment visit. Response to electrical stimulation will be tested at the baseline visit and is described in detail in the section entitled "Muscle Responsiveness Testing" below. Based on the Muscle Responsiveness Testing procedures and criteria, the withdrawal criteria for non-response to electrical stimulation is defined as:
- More than 3 muscle groups out of 11 not- responding to FES or
- The participant reports a discomfort level score of 8 or 10 on the FACES scale (Appendix A) for any of the 11 muscle groups.
- Participant receives any other active occupational therapy or hemiplegic hand intervention during the FES intervention period.
- Participant attends less than 36/48 FES intervention sessions.
- Participant develops new-onset seizures during the FES intervention period.
Sites / Locations
Arms of the Study
Arm 1
Experimental
FES Therapy
FES therapy will be administered over the course of 1 hour sessions that will be take place 3 times per week over 16 weeks, for a total of 48 sessions.