N/A N=15 Randomized Single-blind Treatment

Contralaterally Controlled FES for Hand Opening in Hemiplegic Cerebral Palsy

Cerebral Palsy

Bottom Line

View on ClinicalTrials.gov: NCT02925455 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2021

Primary outcome: Primary: Change in Assisting Hands Assessment Logit Score at End of Treatment — 2.63; 4.33 Scores on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Contralaterally-controlled functional electrical stimulation (Device); Hand therapy video games (Device)
Age: Pediatric · 6+ yrs
Sex: All
Sponsor: MetroHealth Medical Center
Primary completion: Dec 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Assisting Hands Assessment Logit Score at End of Treatment	2.63; 4.33	—
SECONDARY Change in Melbourne 2 Motor Assessment at End of Treatment	3.50; 6.17; 1.91; -2.00; 9.49; 7.02	—

Summary

This is a pilot randomized controlled trial of an intervention to improve arm function in children ages 6 to 17 with cerebral palsy and upper limb hemiparesis. Twenty participants will be randomized to either a group treated with neuromuscular electrical stimulation and video games or video games alone. Both groups will receive 6 wks of treatment consisting of home and lab sessions. Both the experiment group and control group interventions consist of therapist-guided sessions in the rehabilitation clinic and self-administered or caregiver-assisted sessions at home. While both groups will receive the same task practice and video game training, only the experiment group will receive an electrical stimulation device to assist with hand opening during practice. Changes in upper extremity motor impairment and function will be assessed for each participant at baseline, mid treatment, end of treatment and at 3 mo follow-up.

Eligibility Criteria

Inclusion Criteria

Upper Extremity hemiparesis from Cerebral Palsy
Age 6-17
Caregiver can transport participant to weekly sessions and assist with home treatment
Medically stable; stable medications
Recall 2 of 3 items after 30 min
Finger extension strength ≤ 4/5 on paretic side
Able to follow 3-stage commands
Adequate active movement of paretic arm to position the hand for table-top task practice
Skin intact on hemiparetic arm
Surface neuromuscular electrical stimulation trial opens hand without pain
Full volitional hand opening and closing of contralateral hand
Box & Blocks Score of weaker side < 90% of stronger side score
Able to hear and respond to auditory cues
English proficiency of both caregiver and child

Exclusion Criteria

Uncontrolled seizure disorder
Co-existing neurological conditions other than cerebral palsy affecting the hemiparetic upper limb (e.g., peripheral nerve injury, Parkinson's disease, spinal cord injury, traumatic brain injury, multiple sclerosis, stroke, hemispherectomy)
Severely impaired cognition and communication
History of cardiac arrhythmias with hemodynamic instability
Insensate arm, forearm, or hand
Uncompensated hemi-neglect
Cardiac pacemaker or any other implanted electronic systems
Pregnant
Intramuscular Botox injections in any upper extremity muscle in the last 3 months
Severe visual impairment

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02925455). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.