Back to resultsImproving Gait and Balance in Children With Hemiplegic Cerebral Palsy: Gait Myoelectric Stimulator Study
Primary Purpose
Hemiplegic Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Gait Myoelectric Stimulator
5210
Sponsored by
About this trial
This is an interventional treatment trial for Hemiplegic Cerebral Palsy
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Gait Myoelectric Stimulator
Ready, Set, Go! 5210 program
Arm Description
The Gait Myoelectric Stimulator device stimulates the dorsiflexor and plantarflexor muscles at the correct time for typical walking.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Aim 2 - Improve walking symmetry, as measured by Noraxon video software
To determine if the GMES program will improve walking symmetry. Symmetry will be calculated using Noraxon for 10 strides for each testing. Normal walking consists of 60% of the time standing on one foot (stance phase) and 40% with the foot in the air (swing phase). It is common for children with hemiplegia to have asymmetrical stance between right and left legs.
The stance phase begins when the foot makes contact with the ground (initial contact) and ends when the foot leaves the ground (toe-off). The swing phase begins with toe-off and ends at initial contact. These gait events (initial contact and toe-off) are determined from freeze frame videotape for children as they walk in the laboratory. Noraxon software calculates these times and determines the percentage for right and left leg.
Gait symmetry will be assessed as the difference in the percentages of the stance phase for each subject.
Aim 3 - Improve balance, as measured by the Balance Subtest of the Bruininks-Oseretsky Test of Motor Proficiency (BOT2).
To Determine if the GMES program will improve balance skills based on the Balance Subtest of the Bruininks-Oseretsky Test of Motor Proficiency (BOT2). Balance will be measured on the unaffected and on the hemiplegic side using the Balance Subtest of the BOT2. This test assesses 9 balance areas:
Standing with feet apart on a line - eyes open,
Walking forward on a line,
Standing on one leg on a line - eyes open,
Standing with feet apart on a line - eyes closed,
Walking forward heel-to-toe on a line,
Standing on one leg on a line - eyes closed,
Standing on one leg on a balance beam - eyes open,
Standing heel-to-toe on a balance beam,
Standing on one leg on a balance beam - eyes closed. These balance activities are designed to become more difficult as they progress. They are scored based on how many seconds the subject can balance, or how many steps the subject takes on the balance beam. The total raw score will be reported.
Full Information
NCT ID
NCT03226860
First Posted
April 14, 2017
Last Updated
July 20, 2017
Sponsor
MultiCare Health System Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT03226860
Brief Title
Improving Gait and Balance in Children With Hemiplegic Cerebral Palsy: Gait Myoelectric Stimulator Study
Official Title
Improving Gait and Balance in Children With Hemiplegic Cerebral Palsy: Gait Myoelectric Stimulator Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
August 3, 2015 (Actual)
Primary Completion Date
August 15, 2016 (Actual)
Study Completion Date
December 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MultiCare Health System Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegic Cerebral Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gait Myoelectric Stimulator
Arm Type
Experimental
Arm Description
The Gait Myoelectric Stimulator device stimulates the dorsiflexor and plantarflexor muscles at the correct time for typical walking.
Arm Title
Ready, Set, Go! 5210 program
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Gait Myoelectric Stimulator
Other Intervention Name(s)
GMES
Intervention Description
Electrical stimulation during gait for children with CP
Intervention Type
Other
Intervention Name(s)
5210
Intervention Description
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.
Primary Outcome Measure Information:
Title
Aim 1 - Improve initial contact during gait, as measured by Noraxon video software
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Aim 2 - Improve walking symmetry, as measured by Noraxon video software
Description
To determine if the GMES program will improve walking symmetry. Symmetry will be calculated using Noraxon for 10 strides for each testing. Normal walking consists of 60% of the time standing on one foot (stance phase) and 40% with the foot in the air (swing phase). It is common for children with hemiplegia to have asymmetrical stance between right and left legs.
The stance phase begins when the foot makes contact with the ground (initial contact) and ends when the foot leaves the ground (toe-off). The swing phase begins with toe-off and ends at initial contact. These gait events (initial contact and toe-off) are determined from freeze frame videotape for children as they walk in the laboratory. Noraxon software calculates these times and determines the percentage for right and left leg.
Gait symmetry will be assessed as the difference in the percentages of the stance phase for each subject.
Time Frame
12 weeks
Title
Aim 3 - Improve balance, as measured by the Balance Subtest of the Bruininks-Oseretsky Test of Motor Proficiency (BOT2).
Description
To Determine if the GMES program will improve balance skills based on the Balance Subtest of the Bruininks-Oseretsky Test of Motor Proficiency (BOT2). Balance will be measured on the unaffected and on the hemiplegic side using the Balance Subtest of the BOT2. This test assesses 9 balance areas:
Standing with feet apart on a line - eyes open,
Walking forward on a line,
Standing on one leg on a line - eyes open,
Standing with feet apart on a line - eyes closed,
Walking forward heel-to-toe on a line,
Standing on one leg on a line - eyes closed,
Standing on one leg on a balance beam - eyes open,
Standing heel-to-toe on a balance beam,
Standing on one leg on a balance beam - eyes closed. These balance activities are designed to become more difficult as they progress. They are scored based on how many seconds the subject can balance, or how many steps the subject takes on the balance beam. The total raw score will be reported.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brenna Brandsma, PT, DPT, PCS
Organizational Affiliation
Physical Therapist for Mary Bridge Children's Therapy at Good Samaritan
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Improving Gait and Balance in Children With Hemiplegic Cerebral Palsy: Gait Myoelectric Stimulator Study
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