Cerebral Palsy Spastic DiplegiaCP FES CyclingNCT04688424
FES Assisted Cycling in Children With CP
A study testing FES and Cycling in people with Cerebral Palsy Spastic Diplegia, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
This project proposes to assess if Functional Electrical Stimulation (FES) assisted cycling can improve the cycling ability, muscle strength, cardiovascular health, quality of life, self perception and functional mobility of adolescents with CP better than a volitional cycling program or a non-intervention control… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Cerebral Palsy Spastic Diplegia
- What is being tested?
- FES and Cycling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to 30 Jun 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Spastic CP (di-, tetra-, or triplegic)
- Level II, III or IV GMFCS classification
- Sufficient covering of the femoral head in the acetabulum (migration % < 40)
- Adequate range of motion of the hips, knees and ankles to allow pedaling
- Visual, perceptual, cognitive, and communication skills to follow multiple step commands for attending to exercise and data collection
- Seizure-free or well controlled seizures
Who cannot join
- Athetoid, ataxic, or hemiplegic CP
- Significant scoliosis (primary curve > 40°)
- Spinal fusions extending into the pelvis
- Severe tactile hypersensitivity
- Joint instability or dislocation in LE
- LE surgery or fractures in the past year
Show all 12Show fewer
- Botox injections to LE in the past 6 months
- Severe spasticity in LE (Mod Ashworth 4)
- LE joint pain during cycling
- Hx of pulmonary disease limiting exercise tolerance or Hx of cardiac disease
- Severely limited ROM / contractures that prevent the subject from being able to be safely positioned on the cycle
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Shriners Hospitals fof Children, Philadelphia
Philadelphia, Pennsylvania, 19140
About this study
Official title: Functional Electrical Stimulation Assisted Cycling to Improve Fitness and Strength in Children With Cerebral Palsy
This project proposes to assess if Functional Electrical Stimulation (FES) assisted cycling can improve the cycling ability, muscle strength, cardiovascular health, quality of life, self perception and functional mobility of adolescents with CP better than a volitional cycling program or a non-intervention control group.
Read the detailed description
Aim 1: To compare the effects of 8-weeks of FES-assisted cycling training on improving cardiorespiratory fitness, walking function, self-motivated exercise/recreation, self-perception and functional mobility and quality of life of adolescents with spastic CP with marginal walking ability (Gross Motor Function Classification System Levels II - IV) vs. 8-weeks of volitional cycling training and a non-intervention control group.
Aim 2: To compare the effects of 8-weeks FES-assisted cycling training on changes in cycling ability of adolescents with spastic CP with marginal walking ability vs. 8-weeks of volitional cycling training and a nonintervention control group.
Aim 3: To elucidate the mechanisms for potential improvements in cycling ability after 8-weeks of FES-assisted or volitional cycling training of adolescents with spastic CP and marginal walking ability.
- Conditions
- Cerebral Palsy Spastic Diplegia
- Being tested
- FES, Cycling
- Keywords
- Cerebral Palsy, Functional electrical stimulation, Cycling
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FESDevice
FES will be applied via surface electrodes placed over bilateral quadriceps muscles. FES-stimulation will be ramped from sensory level (the level at which the individual feels a cutaneous sensation from the stimulation) to the maximum-tolerated level using a closed loop system controlled by computer software Subjects will exercise at home, three times per week, with FES on for 8 weeks with a goal of attaining 30 minutes of continuous cycling per session. If the individuals are unable to cycle for 30 continuous minutes, rest breaks will be provided with a goal of cycling for a total of 30 minutes. The length of each session will be approximately 45 minutes, with 15 minutes of set-up and 30 minutes of cycling.
CyclingOther
Subjects will exercise at home, three times per week, without FES for 8 weeks with a goal of attaining 30 minutes of continuous cycling per session. If the individuals are unable to cycle for 30 continuous minutes, rest breaks will be provided with a goal of cycling for a total of 30 minutes. The length of each session will be approximately 45 minutes, with 15 minutes of set-up and 30 minutes of cycling.
| Study group | Role | What they receive |
|---|---|---|
| FES + Cycling | Experimental | Functional electrical stimulation cycling group Receives: Device: FES; Other: Cycling |
| Cycling only | Active comparator | Volitional cycling group (no electrical stimulation) Receives: Other: Cycling |
| Control | No intervention | control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cycling Ability
Change in cycling cadence from pre-training to post-training and at follow-up will be assessed.
Measured: Outcome assessed: Pre Training (week 0), Mid Training (week 4), Post Training (week 8), Follow-Up (week 16)
Change in Energy Expenditure
Energy expenditure is a measure of cardiovascular fitness. Change in energy expenditure from pre-training to post-training and at follow-up will be assessed.
Measured: Outcome assessed: Pre Training (week 0), Mid Training (week 4), Post Training (week 8), Follow-Up (week 16)
Change in Gait speed
Gait speed will be measured using a GAITRite Portable Walkway System (CIR Systems Inc; Havertown, PA). We will measure the change in gait speed from pre-training to post-training and at follow-up.
Measured: Outcome assessed: Before Training (week 0), Mid Training (week 4), After Training (week 8), Follow-Up (week 16)
Change in Spatiotemporal gait parameter
Step length will be measured using a GAITRite Portable Walkway System (CIR Systems Inc; Havertown, PA). We will measure the change in step length from pre-training to post-training and at follow-up.
Measured: Outcome assessed: Before Training (week 0), Mid Training (week 4), After Training (week 8), Follow-Up (week 16)
Change in Muscle Strength
Isometric maximum voluntary exertion testing of hip extensors \& flexors, knee extensors \& flexors, and ankle plantarflexors. We will measure the change in isometric maximum voluntary exertion from pre-training to post-training and at follow-up.
Measured: Outcome assessed: Before Training (week 0), Mid Training (week 4), After Training (week 8), Follow-Up (week 16)
Change in Walking Distance
6 minute walk test (6MWT) measures walking distance. Walking distance (in a fixed period of time) is an indicator of endurance. We will measure the change in walking distance from pre-training to post-training and at follow-up.
Measured: Outcome assessed: Before Training (week 0), Mid Training (week 4), After Training (week 8), Follow-Up (week 16)
Change in Timed Up-And-Go
Timed Up-And-Go (TUG) is a measure of functional mobility and will allow for assessing the impact of anticipated improvements in motor control and gait biomechanics. We will measure the change in TUG test from pre-training to post-training and at follow-up.
Measured: Outcome assessed: Before Training (week 0), Mid Training (week 4), After Training (week 8), Follow-Up (week 16)
Change in Pedometer measurement
Pedometer measurements to allow an unbiased report of the subject's activity level at home and in the community. We will measure the change in pedometer measurements from pre-training to post-training and at follow-up.
Measured: Outcome assessed: Before Training (week 0), Mid Training (week 4), After Training (week 8), Follow-Up (week 16)
Change in Electromyography
Muscle activation timing measured with electromyography (EMG) during analysis allows for mechanistic study of anticipated improvements in motor control as well as comparison to typical norms. We will measure the change in EMG from pre-training to post-training and at follow-up.
Measured: Outcome assessed: Before Training (week 0), Mid Training (week 4), After Training (week 8), Follow-Up (week 16)
Change in Self-Assessment
Canadian Occupational Performance Measure (COPM) is a 10 point scale to rate one's own level of performance and satisfaction with performance. 1 mean poor performance low satisfaction and 10 means very good performance high satisfaction. We will measure the change in COPM scores from pre-training to post-training and at follow-up.
Measured: Outcome assessed: Before Training (week 0), Mid Training (week 4), After Training (week 8), Follow-Up (week 16)
Change in Health related Quality of Life
The KINDL questionnaire is administered to measure changes in health-related quality of life. The questionnaire is completed by the adolescent and a caregiver. The KINDL standard scale and "Disease Module" is administered. The standard scale contains 24 items comprised of Physical, Emotional, Self-Esteem, Family, Friends and School sub-scales. The 6-item "Disease Module" that measures the child's and caregiver's perceptions about CP. Scores for each item ranges from 1-5. The total score is the sum of all item scores, transformed to a 0-100 scale. Higher scores indicate better quality of life. We will measure the change in KINDL scores from pre-training to post-training and at follow-up.
Measured: Outcome assessed: Before Training (week 0), Mid Training (week 4), After Training (week 8), Follow-Up (week 16)
Change in Self-Perception
Self-Perception (Piers-Harris-2) survey measures physical and emotional well-being and self-esteem and will allow assessment of the impact of anticipated improvements in motor control and gait biomechanics from training. We will measure the change in Piers-Harris scores from pre-training to post-training and at follow-up.
Measured: Outcome assessed: Before Training (week 0), Mid Training (week 4), After Training (week 8), Follow-Up (week 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study startApr 2008
- Primary completion30 Jun 2016
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy Spastic DiplegiaStudies 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
- None (open label)
- Enrolment
- 39 participants (actual)
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
- Responsible party
- Principal investigator, Samuel C.K. Lee, PhD, PT, University of Delaware
- Investigators
- Samuel Lee, PT, PhD, Principal investigator, Physical Therapy Department, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04688424
- Sponsor's protocol ID
- 5R01HD062588-02
- Acronym
- CP FES Cycling
- Status last verified
- Dec 2020
- First submitted
- 15 May 2015
- Last updated
- 30 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The proposed experiments will generate data for publications in high quality peer reviewed journals. We will also present our findings at national meetings of neurorehabilitation scientists and clinicians and neuroscience and motor control meetings. To have the most impact, it is important that we present our findings to both clinicians and scientists, therefore, in addition to these standard approaches, we will seek out regular opportunities to present both the rationale and results of our work to local and regional clinicians as well as local and regional stroke support groups.
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Electrical Stimulation Assisted Cycling to Improve Fitness and Strength in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04688424
- Acronym / sponsor ID
- CP FES Cycling / 5R01HD062588-02
- Conditions
- Cerebral Palsy Spastic Diplegia
- Keywords
- Cerebral Palsy, Functional electrical stimulation, Cycling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Collaborators
- Shriners Hospitals for Children
- Study start
- Apr 2008
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 30 Dec 2020 (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 project proposes to assess if Functional Electrical Stimulation (FES) assisted cycling can improve the cycling ability, muscle strength, cardiovascular health, quality of life, self perception and functional mobility of adolescents with CP better than a volitional cycling program or a non-intervention control group.
Detailed description
Aim 1: To compare the effects of 8-weeks of FES-assisted cycling training on improving cardiorespiratory fitness, walking function, self-motivated exercise/recreation, self-perception and functional mobility and quality of life of adolescents with spastic CP with marginal walking ability (Gross Motor Function Classification System Levels II - IV) vs. 8-weeks of volitional cycling training and a non-intervention control group.
Aim 2: To compare the effects of 8-weeks FES-assisted cycling training on changes in cycling ability of adolescents with spastic CP with marginal walking ability vs. 8-weeks of volitional cycling training and a nonintervention control group.
Aim 3: To elucidate the mechanisms for potential improvements in cycling ability after 8-weeks of FES-assisted or volitional cycling training of adolescents with spastic CP and marginal walking ability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FES + Cycling | Experimental | Device: FES, Other: CyclingFunctional electrical stimulation cycling group |
| Cycling only | Active comparator | Other: CyclingVolitional cycling group (no electrical stimulation) |
| Control | No intervention | –control group |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Spastic CP (di-, tetra-, or triplegic)
- Level II, III or IV GMFCS classification
- Sufficient covering of the femoral head in the acetabulum (migration % < 40)
- Adequate range of motion of the hips, knees and ankles to allow pedaling
- Visual, perceptual, cognitive, and communication skills to follow multiple step commands for attending to exercise and data collection
Key exclusion criteria (12 listed)
- Athetoid, ataxic, or hemiplegic CP
- Significant scoliosis (primary curve > 40°)
- Spinal fusions extending into the pelvis
- Severe tactile hypersensitivity
- Joint instability or dislocation in LE
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 |
|---|---|---|
| FESFES will be applied via surface electrodes placed over bilateral quadriceps muscles. FES-stimulation will be ramped from sensory level (the level at which the individual feels a cutaneous sensation from the stimulation) to the maximum-tolerated level using a closed loop system controlled by computer software Subjects will exercise at home, three times per week, with FES on for 8 weeks with a goal of attaining 30 minutes of continuous cycling per session. If the individuals are unable to cycle for 30 continuous minutes, rest breaks will be provided with a goal of cycling for a total of 30 minutes. The length of each session will be approximately 45 minutes, with 15 minutes of set-up and 30 minutes of cycling. | Device | FES + Cycling |
| CyclingSubjects will exercise at home, three times per week, without FES for 8 weeks with a goal of attaining 30 minutes of continuous cycling per session. If the individuals are unable to cycle for 30 continuous minutes, rest breaks will be provided with a goal of cycling for a total of 30 minutes. The length of each session will be approximately 45 minutes, with 15 minutes of set-up and 30 minutes of cycling. | Other | Cycling only, FES + Cycling |
Primary outcome
Change in cycling Ability
Time frame: Outcome assessed: Pre Training (week 0), Mid Training (week 4), Post Training (week 8), Follow-Up (week 16)
Change in cycling cadence from pre-training to post-training and at follow-up will be assessed.
Change in Energy Expenditure
Time frame: Outcome assessed: Pre Training (week 0), Mid Training (week 4), Post Training (week 8), Follow-Up (week 16)
Energy expenditure is a measure of cardiovascular fitness. Change in energy expenditure from pre-training to post-training and at follow-up will be assessed.
Change in Gait speed
Time frame: Outcome assessed: Before Training (week 0), Mid Training (week 4), After Training (week 8), Follow-Up (week 16)
Gait speed will be measured using a GAITRite Portable Walkway System (CIR Systems Inc; Havertown, PA). We will measure the change in gait speed from pre-training to post-training and at follow-up.
Change in Spatiotemporal gait parameter
Time frame: Outcome assessed: Before Training (week 0), Mid Training (week 4), After Training (week 8), Follow-Up (week 16)
Step length will be measured using a GAITRite Portable Walkway System (CIR Systems Inc; Havertown, PA). We will measure the change in step length from pre-training to post-training and at follow-up.
Change in Muscle Strength
Time frame: Outcome assessed: Before Training (week 0), Mid Training (week 4), After Training (week 8), Follow-Up (week 16)
Isometric maximum voluntary exertion testing of hip extensors \& flexors, knee extensors \& flexors, and ankle plantarflexors. We will measure the change in isometric maximum voluntary exertion from pre-training to post-training and at follow-up.
Change in Walking Distance
Time frame: Outcome assessed: Before Training (week 0), Mid Training (week 4), After Training (week 8), Follow-Up (week 16)
6 minute walk test (6MWT) measures walking distance. Walking distance (in a fixed period of time) is an indicator of endurance. We will measure the change in walking distance from pre-training to post-training and at follow-up.
Change in Timed Up-And-Go
Time frame: Outcome assessed: Before Training (week 0), Mid Training (week 4), After Training (week 8), Follow-Up (week 16)
Timed Up-And-Go (TUG) is a measure of functional mobility and will allow for assessing the impact of anticipated improvements in motor control and gait biomechanics. We will measure the change in TUG test from pre-training to post-training and at follow-up.
Change in Pedometer measurement
Time frame: Outcome assessed: Before Training (week 0), Mid Training (week 4), After Training (week 8), Follow-Up (week 16)
Pedometer measurements to allow an unbiased report of the subject's activity level at home and in the community. We will measure the change in pedometer measurements from pre-training to post-training and at follow-up.
Change in Electromyography
Time frame: Outcome assessed: Before Training (week 0), Mid Training (week 4), After Training (week 8), Follow-Up (week 16)
Muscle activation timing measured with electromyography (EMG) during analysis allows for mechanistic study of anticipated improvements in motor control as well as comparison to typical norms. We will measure the change in EMG from pre-training to post-training and at follow-up.
Change in Self-Assessment
Time frame: Outcome assessed: Before Training (week 0), Mid Training (week 4), After Training (week 8), Follow-Up (week 16)
Canadian Occupational Performance Measure (COPM) is a 10 point scale to rate one's own level of performance and satisfaction with performance. 1 mean poor performance low satisfaction and 10 means very good performance high satisfaction. We will measure the change in COPM scores from pre-training to post-training and at follow-up.
Change in Health related Quality of Life
Time frame: Outcome assessed: Before Training (week 0), Mid Training (week 4), After Training (week 8), Follow-Up (week 16)
The KINDL questionnaire is administered to measure changes in health-related quality of life. The questionnaire is completed by the adolescent and a caregiver. The KINDL standard scale and "Disease Module" is administered. The standard scale contains 24 items comprised of Physical, Emotional, Self-Esteem, Family, Friends and School sub-scales. The 6-item "Disease Module" that measures the child's and caregiver's perceptions about CP. Scores for each item ranges from 1-5. The total score is the sum of all item scores, transformed to a 0-100 scale. Higher scores indicate better quality of life. We will measure the change in KINDL scores from pre-training to post-training and at follow-up.
Change in Self-Perception
Time frame: Outcome assessed: Before Training (week 0), Mid Training (week 4), After Training (week 8), Follow-Up (week 16)
Self-Perception (Piers-Harris-2) survey measures physical and emotional well-being and self-esteem and will allow assessment of the impact of anticipated improvements in motor control and gait biomechanics from training. We will measure the change in Piers-Harris scores from pre-training to post-training and at follow-up.
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 30 Dec 2020.
- Dr. Lee's research studiesLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The proposed experiments will generate data for publications in high quality peer reviewed journals. We will also present our findings at national meetings of neurorehabilitation scientists and clinicians and neuroscience and motor control meetings. To have the most impact, it is important that we present our findings to both clinicians and scientists, therefore, in addition to these standard approaches, we will seek out regular opportunities to present both the rationale and results of our work to local and regional clinicians as well as local and regional stroke support groups.
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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 Lee, PT, PhD principal investigator
Physical Therapy Department, University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FES and Cycling in people with Cerebral Palsy Spastic Diplegia, 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 6 inclusion and 12 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 30 Dec 2020. 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.
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?
Change in cycling Ability (time frame: Outcome assessed: Pre Training (week 0), Mid Training (week 4), Post Training (week 8), Follow-Up (week 16)). The study lists 12 primary outcomes in all. 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 30 Dec 2020.