N/A
Completed N=15
Contralaterally Controlled FES for Hand Opening in Hemiplegic Cerebral Palsy
Source: ClinicalTrials.gov NCT02925455 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcomePrimary: Change in Assisting Hands Assessment Logit Score at End of Treatment — 2.63; 4.33 Scores on a scale
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.
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 | — |
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
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. Informational only — not medical advice.