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

NCT03226860 | Completed

• 1 other identifier: 15.15
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hemiplegic Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

• Aim 1 - Improve initial contact during gait, as measured by Noraxon video software

  To determine if the GMES program will improve initial contact during free speed walking (ie decrease toe first or flat foot contact, and increase heel strike). Based on visual examination of freeze frame videotaped walking patterns, "foot contact" will be scored at initial contact as either heel, foot flat, or toe. A numerical assignment will be placed for each of these contact points. Each step with the heel contact (the most optimal), will receive a score of 3. Each step with the foot flat (the less optimal), will receive a score of 2. Each step the toe contact, (the least optimal), will receive a score of 1. A total of 10 initial contacts will be examined at each testing. The numerical value of the total number of contact points will be calculated for each subject and each trial.

  12 weeks

Secondary Outcomes (2)

• Aim 2 - Improve walking symmetry, as measured by Noraxon video software

  12 weeks

• Aim 3 - Improve balance, as measured by the Balance Subtest of the Bruininks-Oseretsky Test of Motor Proficiency (BOT2).

  12 weeks

Study Arms (2)

Gait Myoelectric Stimulator

EXPERIMENTAL

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

Device: Gait Myoelectric Stimulator

Ready, Set, Go! 5210 program

ACTIVE COMPARATOR

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.

Other: 5210

Interventions

Gait Myoelectric Stimulator DEVICE

Electrical stimulation during gait for children with CP

Also known as: GMES

Gait Myoelectric Stimulator

5210 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.

Ready, Set, Go! 5210 program

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• MultiCare Health System Research Institute: lead

Study Officials

• Brenna Brandsma, PT, DPT, PCS

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2017
• First Posted: July 24, 2017
• Study Start: August 3, 2015
• Primary Completion: August 15, 2016
• Study Completion: December 1, 2016
• Last Updated: July 24, 2017

Record last verified: 2017-07