Contralaterally Controlled FES for Hand Opening in Hemiplegic Cerebral Palsy
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Neurology, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 6 - 17 |
| Updated: | 3/30/2019 |
| Start Date: | September 2016 |
| End Date: | April 2019 |
Contralaterally Controlled Functional Electrical Stimulation for Hand Opening in Hemiplegic Cerebral Palsy: Pilot Randomized Controlled Trial
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.
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.
Rehabilitation clinic sessions - These will occur up to twice per week for the first 3 weeks
and once per week for the second 3 weeks of the 6 week treatment. They are therapist-guided
and last up to 90 min consisting of 45 minutes of contralaterally-controlled functional
electrical stimulation (CCFES)-mediated video games and up to 45 minutes of CCFES-mediated
functional task practice. Early sessions will focus on training the patient and caregiver to
self-administer play of a CCFES-mediated video game at home. As proficiency with one game
develops, more games will be introduced. The functional task practice part of the session
will engage the participant in using the CCFES system to assist them in practicing using
their hand in activities such as lacing beads, throwing balls, eating finger foods, and other
play and activities of daily living. Prior to the start of lab treatment, the investigators
will assess hand extensor and flexor muscle co-activation (see below).
Home sessions - These consist of CCFES-mediated hand opening and video game exercises with
caregiver assistance and supervision as needed. As proficiency develops and more games are
added, each home session will increase in duration up to 90 minutes per day, as determined by
the treating therapist based on the adherence of each participant. Self report of game
difficulty and engagement will be made at the completion of each game (see below)
and once per week for the second 3 weeks of the 6 week treatment. They are therapist-guided
and last up to 90 min consisting of 45 minutes of contralaterally-controlled functional
electrical stimulation (CCFES)-mediated video games and up to 45 minutes of CCFES-mediated
functional task practice. Early sessions will focus on training the patient and caregiver to
self-administer play of a CCFES-mediated video game at home. As proficiency with one game
develops, more games will be introduced. The functional task practice part of the session
will engage the participant in using the CCFES system to assist them in practicing using
their hand in activities such as lacing beads, throwing balls, eating finger foods, and other
play and activities of daily living. Prior to the start of lab treatment, the investigators
will assess hand extensor and flexor muscle co-activation (see below).
Home sessions - These consist of CCFES-mediated hand opening and video game exercises with
caregiver assistance and supervision as needed. As proficiency develops and more games are
added, each home session will increase in duration up to 90 minutes per day, as determined by
the treating therapist based on the adherence of each participant. Self report of game
difficulty and engagement will be made at the completion of each game (see below)
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
We found this trial at
2
sites
2049 E 100th St
Cleveland, Ohio 44106
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Ryan Suder, PhD
Phone: 216-636-5437
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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2500 Metrohealth Dr
Cleveland, Ohio 44109
Cleveland, Ohio 44109
(216) 778-7800
Principal Investigator: Michael J Fu, PhD
Phone: 216-957-3597
MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
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