Spastic Diplegic Cerebral PalsyPhase 1NCT00356343
Strength Training Using Neuromuscular Electrical Stimulation For Children With Cerebral Palsy
A Phase 1 study testing NMES Strength Training and Volitional Strength Training in people with Spastic Diplegic Cerebral Palsy, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
The purpose of this study is to determine if using high-intensity, short-duration, intermittent neuromuscular electrical stimulation (NMES) is better than volitional exercise in increasing quadriceps femoris and triceps surae force-generating potential and gross motor function in children with cerebral palsy. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Spastic Diplegic Cerebral Palsy
- What is being tested?
- NMES Strength Training and Volitional Strength Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Sep 2009
- Phase
- Phase 1
- 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children ages 7-12 years old
- Diagnosis of spastic diplegic cerebral palsy
- GMFCS level of II or III (able to walk indoors and outdoors with or without an assistive device)
- PROM requirements (<10 degree hip flexion contracture, >20 degrees of hip abduction, < 5 degrees of knee flexion contracture, > 45 degree popliteal angle, ankle dorsiflexion to neutral with knee extension)
- Sufficient cognitive/communication skills to perform volitional muscle contractions and complete data collection procedures
Who cannot join
- Significant orthopedic impairments (hip MIGR > 40%, significant scoliosis)
- Must be at least one year post orthopedic surgery
- Must be at least 6 months post botulinum toxin injections
- Uncontrolled seizure activity
Trial locations and contacts
1 site in 1 country.
United States1 site
Shriners Hospitals for Children, Philadelphia
Philadelphia, Pennsylvania, 19140
About this study
Official title: Strength Training Using NMES for Children With Cerebral Palsy
The purpose of this study is to determine if using high-intensity, short-duration, intermittent neuromuscular electrical stimulation (NMES) is better than volitional exercise in increasing quadriceps femoris and triceps surae force-generating potential and gross motor function in children with cerebral palsy.
Read the detailed description
The overall goal of this study is to determine if using high-intensity, short-duration, intermittent neuromuscular electrical stimulation (NMES) is better than volitional exercise in increasing quadriceps femoris and triceps surae force-generating potential and gross motor function in children with cerebral palsy. This study consists of a randomized controlled trial in which the effects of NMES applied to the quadriceps femoris and triceps surae are compared to the effects of volitional isometric exercise and a non-exercising control group. This project assesses the ability of NMES to increase muscle force generating ability, the mechanisms behind changes in force generating ability, and the effects of training on spatiotemporal parameters of gait and gross motor function in children with cerebral palsy.
Subjects is the NMES group will be implanted with percutaneous electrodes in the medial and lateral heads of the gastrocnemius and the quadriceps (3 electrodes in each lower extremity, implanted bilaterally). During the intervention phase, these subjects will undergo 15 electrically-elicited contractions in each of the implanted muscle groups three times/week (at home), while positioned on an exercise board to maintain good alignment and facilitate isometric contractions. Subjects in the volitional group will perform 15 isometric contractions in each muscle group (quadriceps, triceps surae), while positioned on an exercise board. The non-exercise control group will continue with typical activities, but no intervention will be administered. Subjects are assessed at baseline, 6 weeks into the intervention, 12 weeks into the intervention (at which point the intervention is withdrawn), and at a follow-up assessment 12 weeks after the withdrawal of the intervention.
- Conditions
- Spastic Diplegic Cerebral Palsy
- Being tested
- NMES Strength Training, Volitional Strength Training
- Keywords
- NMES, Cerebral Palsy, Spastic Diplegia, Electrical Stimulation, Children
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMES Strength TrainingDevice
Subjects will complete 12 weeks of NMES isometric strength training using implanted electrodes in bilateral quadriceps and triceps surae muscles.
Volitional Strength TrainingOther
Subjects will complete 12 weeks of volitional isometric strength training of bilateral quadriceps and triceps surae muscles.
| Study group | Role | What they receive |
|---|---|---|
| NMES Strengthening Group | Experimental | Subjects will complete 12 weeks of NMES isometric strength training using implanted electrodes in bilateral quadriceps and triceps surae muscles. Receives: Device: NMES Strength Training |
| Control Group | No intervention | No Intervention Control Group |
| Volitional Strengthening | Active comparator | Subjects will complete 12 weeks of volitional isometric strength training of bilateral quadriceps and triceps surae muscles. Receives: Other: Volitional Strength Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Force generating ability of quadriceps femoris and triceps surae (MVIC)
Measured: Pre, Mid, Post, Washout
Voluntary muscle activation during a Maximal Volitional Isometric Contraction (MVIC)
Measured: Pre, Mid, Post, Washout
Antagonist coactivation during an agonist MVIC
Measured: Pre, Mid, Post, Washout
Contractile properties as assessed via electrically-elicited tests
Measured: Pre, Mid, Post, Washout
Fatiguability of muscle as assessed via electrically-elicited tests
Measured: Pre, Mid, Post, Washout
Muscle cross-sectional area of quadriceps femoris and triceps surae (via MRI with fat suppression)
Measured: Pre, Mid, Post, Washout
Spatiotemporal parameters of gait
Measured: Pre, Mid, Post, Washout
Gross Motor Function Measure
Measured: Pre, Mid, Post, Washout
Timed Up and Go
Measured: Pre, Mid, Post, Washout
Parent and child report via questionnaires (PODCI, COPM)
Measured: Pre, Mid, Post, Washout
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2006 (estimated)
- Study startJul 2004
- Primary completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spastic Diplegic 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Shriners Hospitals for Children, University of Delaware
- Investigators
- Samuel CK Lee, PhD, PT, Principal investigator, University of Delaware, Shriners Hospitals for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00356343
- Sponsor's protocol ID
- R01HD043859
- Status last verified
- Jan 2011
- First submitted
- 25 Jul 2006
- Last updated
- 11 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stackhouse SK, Binder-Macleod SA, Lee SC. Voluntary muscle activation, contractile properties, and fatigability in children with and without cerebral palsy. Muscle Nerve. 2005 May;31(5):594-601. doi: 10.1002/mus.20302.
PubMed 15779003
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strength Training Using NMES for Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT00356343
- Acronym / sponsor ID
- R01HD043859
- Conditions
- Spastic Diplegic Cerebral Palsy
- Keywords
- NMES, Cerebral Palsy, Spastic Diplegia, Electrical Stimulation, Children
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Collaborators
- Shriners Hospitals for Children, University of Delaware
- Study start
- Jul 2004
- Primary completion
- Sep 2009 (estimated)
- First posted
- 26 Jul 2006 (estimated)
- 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.
The purpose of this study is to determine if using high-intensity, short-duration, intermittent neuromuscular electrical stimulation (NMES) is better than volitional exercise in increasing quadriceps femoris and triceps surae force-generating potential and gross motor function in children with cerebral palsy.
Detailed description
The overall goal of this study is to determine if using high-intensity, short-duration, intermittent neuromuscular electrical stimulation (NMES) is better than volitional exercise in increasing quadriceps femoris and triceps surae force-generating potential and gross motor function in children with cerebral palsy. This study consists of a randomized controlled trial in which the effects of NMES applied to the quadriceps femoris and triceps surae are compared to the effects of volitional isometric exercise and a non-exercising control group. This project assesses the ability of NMES to increase muscle force generating ability, the mechanisms behind changes in force generating ability, and the effects of training on spatiotemporal parameters of gait and gross motor function in children with cerebral palsy.
Subjects is the NMES group will be implanted with percutaneous electrodes in the medial and lateral heads of the gastrocnemius and the quadriceps (3 electrodes in each lower extremity, implanted bilaterally). During the intervention phase, these subjects will undergo 15 electrically-elicited contractions in each of the implanted muscle groups three times/week (at home), while positioned on an exercise board to maintain good alignment and facilitate isometric contractions. Subjects in the volitional group will perform 15 isometric contractions in each muscle group (quadriceps, triceps surae), while positioned on an exercise board. The non-exercise control group will continue with typical activities, but no intervention will be administered. Subjects are assessed at baseline, 6 weeks into the intervention, 12 weeks into the intervention (at which point the intervention is withdrawn), and at a follow-up assessment 12 weeks after the withdrawal of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NMES Strengthening Group | Experimental | Device: NMES Strength TrainingSubjects will complete 12 weeks of NMES isometric strength training using implanted electrodes in bilateral quadriceps and triceps surae muscles. |
| Control Group | No intervention | –No Intervention Control Group |
| Volitional Strengthening | Active comparator | Other: Volitional Strength TrainingSubjects will complete 12 weeks of volitional isometric strength training of bilateral quadriceps and triceps surae muscles. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children ages 7-12 years old
- Diagnosis of spastic diplegic cerebral palsy
- GMFCS level of II or III (able to walk indoors and outdoors with or without an assistive device)
- PROM requirements (<10 degree hip flexion contracture, >20 degrees of hip abduction, < 5 degrees of knee flexion contracture, > 45 degree popliteal angle, ankle dorsiflexion to neutral with knee extension)
- Sufficient cognitive/communication skills to perform volitional muscle contractions and complete data collection procedures
Key exclusion criteria (4 listed)
- Significant orthopedic impairments (hip MIGR > 40%, significant scoliosis)
- Must be at least one year post orthopedic surgery
- Must be at least 6 months post botulinum toxin injections
- Uncontrolled seizure activity
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 |
|---|---|---|
| NMES Strength TrainingSubjects will complete 12 weeks of NMES isometric strength training using implanted electrodes in bilateral quadriceps and triceps surae muscles. | Device | NMES Strengthening Group |
| Volitional Strength TrainingSubjects will complete 12 weeks of volitional isometric strength training of bilateral quadriceps and triceps surae muscles. | Other | Volitional Strengthening |
Primary outcome
Force generating ability of quadriceps femoris and triceps surae (MVIC)
Time frame: Pre, Mid, Post, Washout
Voluntary muscle activation during a Maximal Volitional Isometric Contraction (MVIC)
Time frame: Pre, Mid, Post, Washout
Antagonist coactivation during an agonist MVIC
Time frame: Pre, Mid, Post, Washout
Contractile properties as assessed via electrically-elicited tests
Time frame: Pre, Mid, Post, Washout
Fatiguability of muscle as assessed via electrically-elicited tests
Time frame: Pre, Mid, Post, Washout
Muscle cross-sectional area of quadriceps femoris and triceps surae (via MRI with fat suppression)
Time frame: Pre, Mid, Post, Washout
Spatiotemporal parameters of gait
Time frame: Pre, Mid, Post, Washout
Gross Motor Function Measure
Time frame: Pre, Mid, Post, Washout
Timed Up and Go
Time frame: Pre, Mid, Post, Washout
Parent and child report via questionnaires (PODCI, COPM)
Time frame: Pre, Mid, Post, Washout
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2011.
- Results publication: PubMed 15779003Stackhouse SK, Binder-Macleod SA, Lee SC. Voluntary muscle activation, contractile properties, and fatigability in children with and without cerebral palsy. Muscle Nerve. 2005 May;31(5):594-601. doi: 10.1002/mus.20302.
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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.
Samuel CK Lee, PhD, PT principal investigator
University of Delaware, Shriners Hospitals for Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NMES Strength Training and Volitional Strength Training in people with Spastic Diplegic Cerebral Palsy, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
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 4 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: status not confirmed, as of the sponsor's last update on 11 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Force generating ability of quadriceps femoris and triceps surae (MVIC) (time frame: Pre, Mid, Post, Washout). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00356343, which also lists 1 linked publication.
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 11 Jan 2011.