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

NCT ID: NCT03226860

Last Updated: 2017-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-03
• Study Completion Date: 2016-12-01

Brief Summary

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.

Detailed 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.

Conditions

Hemiplegic Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Gait Myoelectric Stimulator

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

Group Type: EXPERIMENTAL

Gait Myoelectric Stimulator

Intervention Type: DEVICE

Electrical stimulation during gait for children with CP

Ready, Set, Go! 5210 program

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.

Group Type: ACTIVE_COMPARATOR

5210

Intervention Type: OTHER

Children will eat 5 fruits/vegetables each day, watch 2 hours or less of screen time, perform 1 hour or more of physical activity, and drink 0 sugar-sweetened beverages.

Interventions

Gait Myoelectric Stimulator

Electrical stimulation during gait for children with CP

Intervention Type: DEVICE

5210

Children will eat 5 fruits/vegetables each day, watch 2 hours or less of screen time, perform 1 hour or more of physical activity, and drink 0 sugar-sweetened beverages.

Intervention Type: OTHER

Other Intervention Names

GMES

Eligibility Criteria

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MultiCare Health System Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brenna Brandsma, PT, DPT, PCS

Role: PRINCIPAL_INVESTIGATOR

Physical Therapist for Mary Bridge Children's Therapy at Good Samaritan

Other Identifiers

15.15

Identifier Type: -

Identifier Source: org_study_id