Clinical trial NCT04209257: FES to Improve Crouch Gait in CP
Official title: Functional Electrical Stimulation to Improve Crouch Gait in Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Gait
Keywords: Cerebral Palsy
Functional electrical stimulation
Neurotherapeutic
Lead sponsor: Shriners Hospitals for Children
Sponsor class: OTHER
First posted: 2019-12-24
Enrollment: 13
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The overall goal of the proposed work is to develop and to assess the feasibility of using functional electrical stimulation (FES) system to improve crouch gait in individuals with cerebral palsy that may prevent the typical downward spiral of walking function decline in individuals with CP that occurs from adolescence into adulthood.

Detailed description: Aim 1: To assess the feasibility of using a multiple channel FES system to produce an immediate neuroprosthetic effect to reduce crouch gait in children and adolescents with spastic diplegic CP.

Aim 2: To assess the feasibility of using a multiple channel FES system as a therapeutic training tool to produce lasting neurotherapeutic effects of diminished crouch gait in children and adolescents with CP.

Eligibility criteria: Inclusion Criteria:

* Age 10-18
* Spastic CP (di-, tetra-, or triplegia)
* Levels I-II GMFCS classification
* Sufficient covering of the femoral head in the acetabulum (migration % \< 40)
* Mild crouch gait (minimum knee flexion 21-40o during stance)
* Potential to gain \> 20 degrees knee extension improvement in stance phase
* Minimum of 0o ankle dorsiflexion passive range of motion (PROM)
* Visual, perceptual, cognitive, and communication skills to follow multiple step commands for attending to exercise and data collection
* Seizure-free or well controlled seizures

Exclusion Criteria:

* Athetoid, ataxic, or hemiplegic CP
* Significant scoliosis (primary curve \> 40°)
* Spinal fusions extending into the pelvis
* Severe tactile hypersensitivity
* Joint instability or dislocation in lower extremity
* Lower extremity surgery or fractures in the past year
* Botox injections to Lower extremity in the past 6 months
* Implanted medical device contraindicated with application of FES
* Severe spasticity in Lower extremity (Mod Ashworth 4)
* Lower extremity joint pain during walking
* Hx of pulmonary disease limiting exercise tolerance or Hx of cardiac disease
* Severely limited range of motion / contractures (\>15o knee flex or \>15o hip flex contractures)
* Pregnancy

Primary outcomes:
measure: Change in the Muscle Tone
timeFrame: Change from the baseline Modified Ashworth Scale at 14 weeks (post training)
measure: Change in the Muscle Tone
timeFrame: Change from the baseline Modified Ashworth Scale at 27 weeks (Follow up)
measure: Metabolic Cost of Walking
timeFrame: Change from the baseline Metabolic Cost of Walking at 14 weeks (post training)
measure: Metabolic Cost of Walking
timeFrame: Change from the baseline Metabolic Cost of Walking at 27 weeks (Follow up)
measure: Change in the Walking Speed
timeFrame: Change from the baseline Walking speed at 14 weeks (Post training)
measure: Change in the Walking Speed
timeFrame: Change from the baseline Walking speed at 27 weeks (Follow up)
measure: Change in the Walking Distance
timeFrame: Change from the baseline Walking Distance at 14 weeks (Post training)
measure: Change in the Walking Distance
timeFrame: Change from the baseline Walking Distance at 27 weeks (Follow up)
measure: Change in Gross Motor Function Measure
timeFrame: Change from the baseline GMFM score at 14 weeks (Post training)
measure: Change in Gross Motor Function Measure
timeFrame: Change from the baseline GMFM score at 27 weeks (Follow up)
measure: Change in the Timed Up-And-Go (TUG time)
timeFrame: Change from the baseline Time Up and Go time at 14 weeks (Post training)
measure: Change in the Timed Up-And-Go (TUG time)
timeFrame: Change from the baseline Time Up and Go time at 27 weeks (Follow up)
measure: Change in the Mini Balance Evaluation Systems Test Score
timeFrame: Change from the baseline Mini BESTest score at 14 weeks (Post training)
measure: Change in the Mini Balance Evaluation Systems Test Score
timeFrame: Change from the baseline Mini BESTest score at 27 weeks (Follow up)
measure: Change in the Electromyography
timeFrame: Change from the baseline Muscle activation at 14 weeks (Post training)
measure: Change in the Electromyography
timeFrame: Change from the baseline Muscle activation at 27 weeks (Follow up)
measure: Changes in the Activities-Specific Balance Scale Score
timeFrame: Change from the baseline ABC scale score at 14 weeks (Post training)
measure: Changes in the Activities-Specific Balance Scale Score
timeFrame: Change from the baseline ABC scale score at 27 weeks (Follow up)
measure: Changes in the Participation in Life Events survey score
timeFrame: Change from the baseline LIFE-H scale score at 14 weeks (Post training)
measure: Changes in the Participation in Life Events survey score
timeFrame: Change from the baseline LIFE-H scale score at 27 weeks (Follow up)
measure: Change in Piers-Harris Children's Self-Concept Scale score
timeFrame: Change from the baseline Piers-Harris Children's Self-Concept scale score at 14 weeks (Post training)
measure: Change in Piers-Harris Children's Self-Concept Scale score
timeFrame: Change from the baseline Piers-Harris Children's Self-Concept scale score at 27 weeks (Follow up)
measure: Change in Joint angles
timeFrame: Change from the baseline Joint angles at 14 weeks (Post training)
measure: Change in Joint angles
timeFrame: Change from the baseline joint angles at 27 weeks (Follow up)
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Shriners Hospitals for Children, Philadelphia
state: Pennsylvania
Study officials:
affiliation: Shriners Hospital for Children & University of Delaware
name: Samuel Lee, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: