Hemiplegic Cerebral PalsyNCT03226860
Improving Gait and Balance in Children With Hemiplegic Cerebral Palsy: Gait Myoelectric Stimulator Study
A study testing Gait Myoelectric Stimulator and 5210 in people with Hemiplegic Cerebral Palsy, run by MultiCare Health System Research Institute.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Hemiplegic Cerebral Palsy
- What is being tested?
- Gait Myoelectric Stimulator and 5210
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 3 Aug 2015to 1 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
About this study
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.
Read the 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
- Being tested
- Gait Myoelectric Stimulator, 5210
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait Myoelectric StimulatorDevice
Also called GMES
Electrical stimulation during gait for children with CP
5210Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Gait Myoelectric Stimulator | Experimental | The Gait Myoelectric Stimulator device stimulates the dorsiflexor and plantarflexor muscles at the correct time for typical walking. Receives: 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. Receives: Other: 5210 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (2)
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start3 Aug 2015
- Primary completion15 Aug 2016
- Study completion1 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegic Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- MultiCare Health System Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brenna Brandsma, PT, DPT, PCS, Principal investigator, Physical Therapist for Mary Bridge Children's Therapy at Good Samaritan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03226860
- Sponsor's protocol ID
- 15.15
- Status last verified
- Jul 2017
- First submitted
- 14 Apr 2017
- Last updated
- 24 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Gait and Balance in Children With Hemiplegic Cerebral Palsy: Gait Myoelectric Stimulator Study
- ClinicalTrials.gov ID
- NCT03226860
- Acronym / sponsor ID
- 15.15
- Conditions
- Hemiplegic Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- MultiCare Health System Research InstituteUniversity, hospital or other
- Study start
- 3 Aug 2015 (actual)
- Primary completion
- 15 Aug 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 24 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gait Myoelectric Stimulator | Experimental | Device: Gait Myoelectric StimulatorThe Gait Myoelectric Stimulator device stimulates the dorsiflexor and plantarflexor muscles at the correct time for typical walking. |
| Ready, Set, Go! 5210 program | Active comparator | Other: 5210Nationwide 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. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Children who are:
Key exclusion criteria (9 listed)
- Children who:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gait Myoelectric StimulatorAlso: GMESElectrical stimulation during gait for children with CP | Device | Gait Myoelectric Stimulator |
| 5210Children 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. | Other | Ready, Set, Go! 5210 program |
Primary outcome
Aim 1 - Improve initial contact during gait, as measured by Noraxon video software
Time frame: 12 weeks
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.
2 secondary outcomes
Aim 2 - Improve walking symmetry, as measured by Noraxon video software
Time frame: 12 weeks
Aim 3 - Improve balance, as measured by the Balance Subtest of the Bruininks-Oseretsky Test of Motor Proficiency (BOT2).
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brenna Brandsma, PT, DPT, PCS principal investigator
Physical Therapist for Mary Bridge Children's Therapy at Good Samaritan
Questions about this trial
What is this clinical trial studying?
A study testing Gait Myoelectric Stimulator and 5210 in people with Hemiplegic Cerebral Palsy, run by MultiCare Health System Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aim 1 - Improve initial contact during gait, as measured by Noraxon video software (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2017.