Study Stopped
Closed by the sponsor for not fully meeting subject recruitment targets.
FES to Improve Gait in CP
CP FES Walking
Functional Electrical Stimulation (FES) to Improve Gait in CP Short Title
1 other identifier
interventional
2
1 country
2
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2019
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2019
CompletedStudy Start
First participant enrolled
October 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedFirst Posted
Study publicly available on registry
October 19, 2020
CompletedOctober 19, 2020
October 1, 2020
2 months
August 20, 2019
October 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (12)
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.
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.
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.
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.
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.
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.
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.
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
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.
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.
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.
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.
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).
Study Arms (3)
FES + Treadmill
EXPERIMENTALFunctional Electrical stimulation walking group.
Treadmill only
ACTIVE COMPARATORTreadmill walking group (no electrical stimulation).
Control
NO INTERVENTIONControl group. After control period of 12 weeks, they are randomized into FES + Treadmill or Treadmill group.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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)
- 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)
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Delaware
Newark, Delaware, 19716, United States
Shriner's Hospital for Children
Philadelphia, Pennsylvania, 19140, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Samuel CK Lee, Ph.D.
University of Delaware
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- All the clinical assessments will be performed by masked Physical Therapist.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 20, 2019
First Posted
October 19, 2020
Study Start
October 24, 2019
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
October 19, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- Time Frame
- Study protocol and data will be shared on publication of primary results
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.