Functional Electrical Stimulation (FES) to Improve Gait in CP Short Title
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 2
- Locations
- 2
- Primary Endpoint
- Muscle Tone
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
All the clinical assessments will be performed by masked Physical Therapist.
Eligibility Criteria
- Ages
- 10 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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)
Exclusion Criteria
- •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.
Arms & Interventions
FES + Treadmill
Functional Electrical stimulation walking group.
Intervention: Functional Electrical Stimulation protocol (Other)
Treadmill only
Treadmill walking group (no electrical stimulation).
Intervention: Treadmill only protocol (Other)
Control
Control group.
After control period of 12 weeks, they are randomized into FES + Treadmill or Treadmill group.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Samuel C.K. Lee, PhD, PT
Principal Investigator
University of Delaware