Cerebral PalsyCP FES WalkingNCT04591288
FES to Improve Gait in CP
A study testing Functional Electrical Stimulation protocol and Treadmill only protocol in people with Cerebral Palsy and Spastic Diplegia Cerebral Palsy, run by Shriners Hospitals for Children at 2 sites in United States.
Trial summary
The goal of this proposal is to mitigate the typical decline in walking function experienced by children with cerebral palsy (CP) via a Functional Electrical Stimulation (FES)-assisted treadmill training intervention. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Cerebral Palsy, Spastic Diplegia Cerebral Palsy, Gait
- What is being tested?
- Functional Electrical Stimulation protocol and Treadmill only protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Oct 2019to 31 Dec 2019
- 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
- Age 10-18
- Diagnosis of spastic diplegic CP
- Gross Motor Functional Classification Scale (GMFCS) level I-III
- Hip migration < 40%
- Displays crouch, equinus, or jump type gait
- At least 0° passive dorsiflexion range of motion (can come to a neutral position)
Show all 12Show fewer
- Sufficient visuoperceptual, cognitive and communication skills
- Seizure-free or well-controlled seizures
- No other neurological or musculoskeletal disorders (e.g. dystonia, severe scoliosis, hip instability)
- Ability to travel to University of Delaware or Shriners Hospital for children multiple times per week for training and assessment
- Ability to communicate pain or discomfort
- Ability to consent (if 18 years old) or obtain parent/guardian consent (if under 18)
Who cannot join
- Diagnosis of athetoid or ataxic CP
- Scoliosis with primary curve > 49%
- Spinal fusions extending into pelvis
- Lower Extremity (LE) joint instability or dislocation
- Severe tactile hypersensitivity
- LE botulinum (Botox) injections in the past 6 mo.
Show all 14Show fewer
- Implanted medical device contraindicative of FES
- Pregnancy
- Severe LE spasticity (Modified Ashworth Scale score of 4 or greater)
- History of pulmonary disease limiting exercise tolerance (Asthma Control screen)
- History of cardiac disease (AHA screen)
- Excessive LE joint pain during walking
- Severely limited joint range of motion / irreversible muscle contractures, i.e.> 10°knee flexion, >15° hip flexion contractures, or >5° plantarflexion contractures
- LE surgery or significant injury within 1 yr.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Delaware
Newark, Delaware, 19716
Shriner's Hospital for Children
Philadelphia, Pennsylvania, 19140
About this study
Official title: Functional Electrical Stimulation (FES) to Improve Gait in CP Short Title
The goal of this proposal is to mitigate the typical decline in walking function experienced by children with cerebral palsy (CP) via a Functional Electrical Stimulation (FES)-assisted treadmill training intervention.
In this study, the investigators intend to use thier CP FES Gait Training System to assess the neurotherapeutic effects of an FES-assisted treadmill training intervention on walking performance in children with CP. The research design consists of a randomized, controlled, two-treatment study in which the control subjects will cross-over into one of the two treatment groups. An FES-assisted training group will undergo twelve weeks of FES-assisted treadmill training using a distributive practice protocol consisting of alternating bouts of walking with and without FES assistance, followed by over ground walking reinforcement. A treadmill-only training group will undergo the same training regimen without FES-assistance. Finally, a non-intervention group will serve as a control. The investigators will analyze treatment efficacy via functional and biomechanical and measures collected pre-training, post-training and after a twelve-week follow-up period.
Read the detailed description
Aim 1: Assess the neurotherapeutic effects of FES-assisted treadmill and treadmill-only training on walking function relative to each other and to the control group.
1.1 The FES-assisted treadmill and treadmill-only groups will demonstrate greater improvements in walking speed and walking distance than the control group post-training and at follow-up. The FES-assisted treadmill group will show greater improvements than the treadmill-only group.
1.2 The FES-assisted treadmill and treadmill-only groups will demonstrate greater improvement in walking energy efficiency than the control group post-training and at follow-up. The FES-assisted treadmill group will show greater improvement than the treadmill-only group.
1.3 The FES-assisted treadmill and treadmill-only groups will demonstrate greater improvements in GMFM, perceived functional mobility, quality of life and self-perception measures than the control group post-training and at follow-up. The FES-assisted treadmill group will show greater improvements than the treadmill-only group.
Aim 2: Assess the differential neurotherapeutic effects of FES-assisted treadmill and treadmill-only training on walking biomechanics. The investigators will measure these effects using instrumented motion capture.
2.1 The FES-assisted treadmill group will demonstrate greater improvements in gait kinematics in stance phase (higher peak hip and knee extension and lower peak ankle dorsiflexion) and swing phase (higher peak knee extension and larger knee excursion) than the treadmill only and non-intervention groups 2.2 The FES-assisted treadmill group will demonstrate greater improvements in lower extremity kinetics (lower hip and knee extensor moments and increased ankle plantarflexion power) than the treadmill only and non- intervention groups.
2.3 The FES-assisted treadmill group will demonstrate greater improvements in spatiotemporal gait parameters (increased step length and gait velocity, decreased step width and double support time) than the treadmill- only and control groups.
Aim 3: Identify predictive measures of training efficacy. 3.1 Pre-training walking speed and energy efficiency will correlate with improvements in walking performance measures of Aim 1.
3.2 Increased neuroprosthetic correction of gait biomechanics measures achieved by FES will be positively correlated with walking performance measures of Aim 1.
- Conditions
- Cerebral Palsy, Spastic Diplegia Cerebral Palsy, Gait
- Being tested
- Functional Electrical Stimulation protocol, Treadmill only protocol
- Keywords
- Cerebral Palsy, Functional electrical stimulation, Neurotherapeutic
- Medical subject headings
- Cerebral Palsy, Cerebral palsy, spastic, diplegic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Electrical Stimulation protocolOther
FES-assisted treadmill walking followed by a 12-week follow-up period. Subjects will train three times a week walking at a target speed corresponding to 60-80% of their age-predicted maximum heart rate. Each training session will consist of five six-minute walking bouts, with five-minute rest periods between bouts. Each treadmill bout consists of alternating one- minute intervals of FES on and FES off. For the last walking bout, the first three minutes will be FES-assisted on the treadmill and the last three minutes will be overground walking without FES assistance to promote carryover effects. Total walking time is 30 minutes and the entire training session lasts approximately 50 minutes.
Treadmill only protocolOther
We will implement a 12-wk Treadmill training protocol consisting of treadmill walking followed by a 12-week follow-up period. Subjects will train three times a week walking at a target speed corresponding to 60-80% of their age. Each training session will consist of five six-minute walking bouts, with five-minute rest periods between bouts. Total walking time is 30 minutes and the entire training session lasts approximately 50 minutes.
| Study group | Role | What they receive |
|---|---|---|
| FES + Treadmill | Experimental | Functional Electrical stimulation walking group. Receives: Other: Functional Electrical Stimulation protocol |
| Treadmill only | Active comparator | Treadmill walking group (no electrical stimulation). Receives: Other: Treadmill only protocol |
| Control | No intervention | Control group. After control period of 12 weeks, they are randomized into FES + Treadmill or Treadmill group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Tone
We use the Modified Ashworth Scale to measure resistance to passive movement about a joint with varying degree of velocity (Muscle tone/spasticity). Score ranges from 0-4, with 6 choices where score of 0 means no increase in tone and score of 4 means rigid limb with no flexion or extension. Our training approach using repetitive electrical stimulation may also lower spasticity, which can also facilitate improved functional mobility.
Measured: Three assessment points in time: a Pre Assessment before beginning training (Week 1), a Post Assessment following training (Week 14), and a Follow-Up Assessment twelve weeks after completion of training (Week 27).
Walking Speed
Walking speed is an indicator of functional mobility. By our training methods, we hypothesize making improvements in motor learning and gait biomechanics. Improved walking speed would indicate that such improvements have occurred.
Measured: Three assessment points in time: a Pre Assessment before beginning training (Week 1), a Post Assessment following training (Week 14), and a Follow-Up Assessment twelve weeks after completion of training (Week 27).
Walking Distance
Walking distance (in a fixed period of time) is an indicator of endurance. Improved motor learning and gait biomechanics from our training methods would improve gait efficiency and thus, endurance.
Measured: Three assessment points in time: a Pre Assessment before beginning training (Week 1), a Post Assessment following training (Week 14), and a Follow-Up Assessment twelve weeks after completion of training (Week 27).
Energy Expenditure
Energy expenditure is a measure of cardiovascular fitness and walking efficiency.
By means of exercise at 60-80% max heart rates, it is expected that cardiovascular fitness would improve. Energy expenditure measurements allow for measurement of cardiovascular fitness.
Measured: Three assessment points in time: a Pre Assessment before beginning training (Week 1), a Post Assessment following training (Week 14), and a Follow-Up Assessment twelve weeks after completion of training (Week 27).
Gross Motor Function Measure
Gross Motor Function Measure (GMFM) is a measure of motor function that indicates disablement. Improved motor control and gait biomechanics from training should be reflected in overall gross motor function, which is assessed via the GMFM.
Measured: Three assessment points in time: a Pre Assessment before beginning training (Week 1), a Post Assessment following training (Week 14), and a Follow-Up Assessment twelve weeks after completion of training (Week 27).
Balance Evaluation Systems Test
Balance Evaluation Systems Test (BESTest) is a measure of balance function. The BESTest will allow for assessing the impact of anticipated improvements in motor control and gait biomechanics from training on balance.
Measured: Three assessment points in time: a Pre Assessment before beginning training (Week 1), a Post Assessment following training (Week 14), and a Follow-Up Assessment twelve weeks after completion of training (Week 27).
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.
Measured: Three assessment points in time: a Pre Assessment before beginning training (Week 1), a Post Assessment following training (Week 14), and a Follow-Up Assessment twelve weeks after completion of training (Week 27).
Instrumented Gait Analysis
Joint Kinematics
Measured: Three assessment points in time: a Pre Assessment before beginning training (Week 1), a Post Assessment following training (Week 14), and a Follow-Up Assessment twelve weeks after completion of training (Week 27).
Electromyography
Muscle activation timing measured with electromyography during gait analysis allows for mechanistic study of anticipated improvements in motor control and gait as well as comparison to typical norms.
Measured: Three assessment points in time: a Pre Assessment before beginning training (Week 1), a Post Assessment following training (Week 14), and a Follow-Up Assessment twelve weeks after completion of training (Week 27).
Activities-Specific Balance Scale
The Activities-Specific Balance Scale (ABC Scale) survey allows measurement of perceived functional mobility by assessing balance confidence to perform daily activities of living without falling. 16 items are rated on a rating scale with range of 0-100. Score of 0 means no confidence and 100 means complete confidence. Average score of 16 items is the overall score. Such measures will assess the impact of anticipated improvements in motor control and gait bio-mechanics from training.
Measured: Three assessment points in time: a Pre Assessment before beginning training (Week 1), a Post Assessment following training (Week 14), and a Follow-Up Assessment twelve weeks after completion of training (Week 27).
Participation in Life Events
Participation in life events (LIFE-H) survey measures how much a person is engaging or participating with their peers and community. Weighted score ranges between 0-10 with 0 score being no accomplishment and 10 means complete accomplishment. Such measures will assess the impact of anticipated improvements in motor control and gait biomechanics from training.
Measured: Three assessment points in time: a Pre Assessment before beginning training (Week 1), a Post Assessment following training (Week 14), and a Follow-Up Assessment twelve weeks after completion of training (Week 27).
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.
Measured: Three assessment points in time: a Pre Assessment before beginning training (Week 1), a Post Assessment following training (Week 14), and a Follow-Up Assessment twelve weeks after completion of training (Week 27).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start24 Oct 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Why it stopped: Closed by the sponsor for not fully meeting subject recruitment targets.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Crossover
- Model description
- It is a randomized controlled two-treatment group clinical trial. We randomly assign subjects to either an FES-Treadmill group, a Treadmill-Only group, or a Control group. The FES-Treadmill group will undergo an FES-assisted treadmill training protocol. The Treadmill-Only group will undergo the same protocol without FES assistance. The control group will not receive treatment. Additionally, following their "no-treatment" period, we will randomize control group subjects into one of the two treatment groups. This design allows us greater power to identify treatment group differences while accommodating parents who might ordinarily not want their child to participate in a non-treatment group. Initially, each group will consist of 14 subjects. Following crossover, the FES-Treadmill and Treadmill-Only groups will consist of 21 subjects while the control group remains 14 subjects.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shriners Hospitals for Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel C.K. Lee, PhD, PT, University of Delaware
- Investigators
- Samuel CK Lee, Ph.D., Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591288
- Sponsor's protocol ID
- PHL1809
- Acronym
- CP FES Walking
- Status last verified
- Oct 2020
- First submitted
- 20 Aug 2019
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- 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. Once the primary hypotheses of the current proposal are tested, all data will be de-identified and be deposited in the DASH (The Data and Specimen Hub) repository.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Electrical Stimulation (FES) to Improve Gait in CP Short Title
- ClinicalTrials.gov ID
- NCT04591288
- Acronym / sponsor ID
- CP FES Walking / PHL1809
- Conditions
- Cerebral Palsy, Spastic Diplegia Cerebral Palsy, Gait
- Keywords
- Cerebral Palsy, Functional electrical stimulation, Neurotherapeutic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed by the sponsor for not fully meeting subject recruitment targets.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Shriners Hospitals for ChildrenUniversity, hospital or other
- Study start
- 24 Oct 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 19 Oct 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.
The goal of this proposal is to mitigate the typical decline in walking function experienced by children with cerebral palsy (CP) via a Functional Electrical Stimulation (FES)-assisted treadmill training intervention.
In this study, the investigators intend to use thier CP FES Gait Training System to assess the neurotherapeutic effects of an FES-assisted treadmill training intervention on walking performance in children with CP. The research design consists of a randomized, controlled, two-treatment study in which the control subjects will cross-over into one of the two treatment groups. An FES-assisted training group will undergo twelve weeks of FES-assisted treadmill training using a distributive practice protocol consisting of alternating bouts of walking with and without FES assistance, followed by over ground walking reinforcement. A treadmill-only training group will undergo the same training regimen without FES-assistance. Finally, a non-intervention group will serve as a control. The investigators will analyze treatment efficacy via functional and biomechanical and measures collected pre-training, post-training and after a twelve-week follow-up period.
Detailed description
Aim 1: Assess the neurotherapeutic effects of FES-assisted treadmill and treadmill-only training on walking function relative to each other and to the control group.
1.1 The FES-assisted treadmill and treadmill-only groups will demonstrate greater improvements in walking speed and walking distance than the control group post-training and at follow-up. The FES-assisted treadmill group will show greater improvements than the treadmill-only group.
1.2 The FES-assisted treadmill and treadmill-only groups will demonstrate greater improvement in walking energy efficiency than the control group post-training and at follow-up. The FES-assisted treadmill group will show greater improvement than the treadmill-only group.
1.3 The FES-assisted treadmill and treadmill-only groups will demonstrate greater improvements in GMFM, perceived functional mobility, quality of life and self-perception measures than the control group post-training and at follow-up. The FES-assisted treadmill group will show greater improvements than the treadmill-only group.
Aim 2: Assess the differential neurotherapeutic effects of FES-assisted treadmill and treadmill-only training on walking biomechanics. The investigators will measure these effects using instrumented motion capture.
2.1 The FES-assisted treadmill group will demonstrate greater improvements in gait kinematics in stance phase (higher peak hip and knee extension and lower peak ankle dorsiflexion) and swing phase (higher peak knee extension and larger knee excursion) than the treadmill only and non-intervention groups 2.2 The FES-assisted treadmill group will demonstrate greater improvements in lower extremity kinetics (lower hip and knee extensor moments and increased ankle plantarflexion power) than the treadmill only and non- intervention groups.
2.3 The FES-assisted treadmill group will demonstrate greater improvements in spatiotemporal gait parameters (increased step length and gait velocity, decreased step width and double support time) than the treadmill- only and control groups.
Aim 3: Identify predictive measures of training efficacy. 3.1 Pre-training walking speed and energy efficiency will correlate with improvements in walking performance measures of Aim 1.
3.2 Increased neuroprosthetic correction of gait biomechanics measures achieved by FES will be positively correlated with walking performance measures of Aim 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- It is a randomized controlled two-treatment group clinical trial. We randomly assign subjects to either an FES-Treadmill group, a Treadmill-Only group, or a Control group. The FES-Treadmill group will undergo an FES-assisted treadmill training protocol. The Treadmill-Only group will undergo the same protocol without FES assistance. The control group will not receive treatment. Additionally, following their "no-treatment" period, we will randomize control group subjects into one of the two treatment groups. This design allows us greater power to identify treatment group differences while accommodating parents who might ordinarily not want their child to participate in a non-treatment group. Initially, each group will consist of 14 subjects. Following crossover, the FES-Treadmill and Treadmill-Only groups will consist of 21 subjects while the control group remains 14 subjects.
| Arm | Type | Receives |
|---|---|---|
| FES + Treadmill | Experimental | Other: Functional Electrical Stimulation protocolFunctional Electrical stimulation walking group. |
| Treadmill only | Active comparator | Other: Treadmill only protocolTreadmill walking group (no electrical stimulation). |
| Control | No intervention | –Control group. After control period of 12 weeks, they are randomized into FES + Treadmill or Treadmill group. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Age 10-18
- Diagnosis of spastic diplegic CP
- Gross Motor Functional Classification Scale (GMFCS) level I-III
- Hip migration < 40%
- Displays crouch, equinus, or jump type gait
Key exclusion criteria (14 listed)
- Diagnosis of athetoid or ataxic CP
- Scoliosis with primary curve > 49%
- Spinal fusions extending into pelvis
- Lower Extremity (LE) joint instability or dislocation
- Severe tactile hypersensitivity
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 |
|---|---|---|
| Functional Electrical Stimulation protocolFES-assisted treadmill walking followed by a 12-week follow-up period. Subjects will train three times a week walking at a target speed corresponding to 60-80% of their age-predicted maximum heart rate. Each training session will consist of five six-minute walking bouts, with five-minute rest periods between bouts. Each treadmill bout consists of alternating one- minute intervals of FES on and FES off. For the last walking bout, the first three minutes will be FES-assisted on the treadmill and the last three minutes will be overground walking without FES assistance to promote carryover effects. Total walking time is 30 minutes and the entire training session lasts approximately 50 minutes. | Other | FES + Treadmill |
| Treadmill only protocolWe will implement a 12-wk Treadmill training protocol consisting of treadmill walking followed by a 12-week follow-up period. Subjects will train three times a week walking at a target speed corresponding to 60-80% of their age. Each training session will consist of five six-minute walking bouts, with five-minute rest periods between bouts. Total walking time is 30 minutes and the entire training session lasts approximately 50 minutes. | Other | Treadmill only |
Primary outcome
Muscle Tone
Time frame: Three assessment points in time: a Pre Assessment before beginning training (Week 1), a Post Assessment following training (Week 14), and a Follow-Up Assessment twelve weeks after completion of training (Week 27).
We use the Modified Ashworth Scale to measure resistance to passive movement about a joint with varying degree of velocity (Muscle tone/spasticity). Score ranges from 0-4, with 6 choices where score of 0 means no increase in tone and score of 4 means rigid limb with no flexion or extension. Our training approach using repetitive electrical stimulation may also lower spasticity, which can also facilitate improved functional mobility.
Walking Speed
Time frame: Three assessment points in time: a Pre Assessment before beginning training (Week 1), a Post Assessment following training (Week 14), and a Follow-Up Assessment twelve weeks after completion of training (Week 27).
Walking speed is an indicator of functional mobility. By our training methods, we hypothesize making improvements in motor learning and gait biomechanics. Improved walking speed would indicate that such improvements have occurred.
Walking Distance
Time frame: Three assessment points in time: a Pre Assessment before beginning training (Week 1), a Post Assessment following training (Week 14), and a Follow-Up Assessment twelve weeks after completion of training (Week 27).
Walking distance (in a fixed period of time) is an indicator of endurance. Improved motor learning and gait biomechanics from our training methods would improve gait efficiency and thus, endurance.
Energy Expenditure
Time frame: Three assessment points in time: a Pre Assessment before beginning training (Week 1), a Post Assessment following training (Week 14), and a Follow-Up Assessment twelve weeks after completion of training (Week 27).
Energy expenditure is a measure of cardiovascular fitness and walking efficiency. By means of exercise at 60-80% max heart rates, it is expected that cardiovascular fitness would improve. Energy expenditure measurements allow for measurement of cardiovascular fitness.
Gross Motor Function Measure
Time frame: Three assessment points in time: a Pre Assessment before beginning training (Week 1), a Post Assessment following training (Week 14), and a Follow-Up Assessment twelve weeks after completion of training (Week 27).
Gross Motor Function Measure (GMFM) is a measure of motor function that indicates disablement. Improved motor control and gait biomechanics from training should be reflected in overall gross motor function, which is assessed via the GMFM.
Balance Evaluation Systems Test
Time frame: Three assessment points in time: a Pre Assessment before beginning training (Week 1), a Post Assessment following training (Week 14), and a Follow-Up Assessment twelve weeks after completion of training (Week 27).
Balance Evaluation Systems Test (BESTest) is a measure of balance function. The BESTest will allow for assessing the impact of anticipated improvements in motor control and gait biomechanics from training on balance.
Timed Up-And-Go
Time frame: Three assessment points in time: a Pre Assessment before beginning training (Week 1), a Post Assessment following training (Week 14), and a Follow-Up Assessment twelve weeks after completion of training (Week 27).
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.
Instrumented Gait Analysis
Time frame: Three assessment points in time: a Pre Assessment before beginning training (Week 1), a Post Assessment following training (Week 14), and a Follow-Up Assessment twelve weeks after completion of training (Week 27).
Joint Kinematics
Electromyography
Time frame: Three assessment points in time: a Pre Assessment before beginning training (Week 1), a Post Assessment following training (Week 14), and a Follow-Up Assessment twelve weeks after completion of training (Week 27).
Muscle activation timing measured with electromyography during gait analysis allows for mechanistic study of anticipated improvements in motor control and gait as well as comparison to typical norms.
Activities-Specific Balance Scale
Time frame: Three assessment points in time: a Pre Assessment before beginning training (Week 1), a Post Assessment following training (Week 14), and a Follow-Up Assessment twelve weeks after completion of training (Week 27).
The Activities-Specific Balance Scale (ABC Scale) survey allows measurement of perceived functional mobility by assessing balance confidence to perform daily activities of living without falling. 16 items are rated on a rating scale with range of 0-100. Score of 0 means no confidence and 100 means complete confidence. Average score of 16 items is the overall score. Such measures will assess the impact of anticipated improvements in motor control and gait bio-mechanics from training.
Participation in Life Events
Time frame: Three assessment points in time: a Pre Assessment before beginning training (Week 1), a Post Assessment following training (Week 14), and a Follow-Up Assessment twelve weeks after completion of training (Week 27).
Participation in life events (LIFE-H) survey measures how much a person is engaging or participating with their peers and community. Weighted score ranges between 0-10 with 0 score being no accomplishment and 10 means complete accomplishment. Such measures will assess the impact of anticipated improvements in motor control and gait biomechanics from training.
Self-Perception
Time frame: Three assessment points in time: a Pre Assessment before beginning training (Week 1), a Post Assessment following training (Week 14), and a Follow-Up Assessment twelve weeks after completion of training (Week 27).
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.
Results and safety
The study was stopped early (reason given: Closed by the sponsor for not fully meeting subject recruitment targets.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Principal Investigator's WebpageLink 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. Once the primary hypotheses of the current proposal are tested, all data will be de-identified and be deposited in the DASH (The Data and Specimen Hub) repository.
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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, Ph.D. principal investigator
University of Delaware
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Electrical Stimulation protocol and Treadmill only protocol in people with Cerebral Palsy and Spastic Diplegia Cerebral Palsy, run by Shriners Hospitals for Children at 2 sites 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 12 inclusion and 14 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: stopped early, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: Closed by the sponsor for not fully meeting subject recruitment targets.). 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?
Muscle Tone (time frame: Three assessment points in time: a Pre Assessment before beginning training (Week 1), a Post Assessment following training (Week 14), and a Follow-Up Assessment twelve weeks after completion of training (Week 27).). 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 19 Oct 2020; AzTrials last refreshed its copy on 6 Nov 2026.