Improving Gait and Balance in Children With Hemiplegic Cerebral Palsy: Gait Myoelectric Stimulator Study

MultiCare Health System Research Institute

Status: Completed

Conditions: Hemiplegic Cerebral Palsy

Treatments: Device: Gait Myoelectric Stimulator; Other: 5210

Study type: Interventional

Funder types: Other

Identifiers

NCT03226860

15.15

Details and patient eligibility

About

This research study will see if electrical stimulation increases heel strike (heel hits the floor first when walking), decreases limp, helps muscle contraction, and improves balance in children with a hemiplegic leg. An experimental electrical stimulation device called the Gait MyoElectric Stimulator (GMES) will be used to stimulate the shin and calf muscles.

Full description

Physical therapists focus on improving gait and balance in children with hemiplegic cerebral palsy (HCP). Functional electrical stimulation (FES) has the potential to improve strength and functional gait for children with HCP. The investigators hypothesize that a new FES system stimulating the dorsiflexor (DF) and plantarflexor (PF) muscles alternately at the correct time during gait, would lead to a significant improvement (p<.05) in foot contact, gait symmetry and balance, compared to 12 weeks of a healthy lifestyle program called 5210.

Enrollment: 15 patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children who are:

  1. Are age 5-18 years
  2. Have been walking independently (no walker or cane) for at least 18 months.
  3. Use co-contraction of DF and PF during walking based upon surface electromyography.
  4. Have a diagnosis of spastic hemiplegic CP, Gross Motor Function Classification System (GMFCS) Levels I-II

Exclusion criteria

• Children who:

  1. Have passive ankle range <5 DF or < 10 PF with hip and knee extended.
  2. Report uncontrolled seizures.
  3. Had orthopedic surgery (for example heel cord or hamstring lengthening)
  4. Have used tone reducing medications (Botox, Baclofen) in the last 6 months.
  5. Wear ankle foot orthoses that limit DF/PF motion.
  6. Have low motivation/tolerance for electrical stimulation.
  7. Have parents/caregivers who are not able or willing to assist with the protocol for 6 months.
  8. Have low tolerance to electrical stimulation in screening process.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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15 participants in 2 patient groups

Gait Myoelectric Stimulator

Experimental group

Description:

The Gait Myoelectric Stimulator device stimulates the dorsiflexor and plantarflexor muscles at the correct time for typical walking.

Treatment:

Device: Gait Myoelectric Stimulator

Ready, Set, Go! 5210 program

Active Comparator group

Description:

Nationwide Initiative which recommends eating 5 servings a day of fruits and vegetables, 2 hours a day or less of screen time, 1 hour/day or more of physical activity, and 0 sugary drinks/day. This program supports the current focus in pediatric physical therapy on life-long fitness in youth with disabilities.

Treatment:

Other: 5210