FES Assisted Cycling in Children With CP

NCT04688424 | Completed DMC FDA Device

• 1 other identifier: 5R01HD062588-02
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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 group.

Conditions

Cerebral Palsy Spastic Diplegia

Keywords

Cerebral Palsy; Functional electrical stimulation; Cycling

Outcome Measures

Primary Outcomes (12)

• Change in cycling Ability

  Change in cycling cadence from pre-training to post-training and at follow-up will be assessed.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Outcome assessed: Before Training (week 0), Mid Training (week 4), After Training (week 8), Follow-Up (week 16)

Study Arms (3)

FES + Cycling

EXPERIMENTAL

Functional electrical stimulation cycling group

Device: FES; Other: Cycling

Cycling only

ACTIVE COMPARATOR

Volitional cycling group (no electrical stimulation)

Other: Cycling

Control

NO INTERVENTION

control group

Interventions

FES DEVICE

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.

FES + Cycling

Cycling OTHER

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.

Cycling only; FES + Cycling

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead
• Shriners Hospitals for Children: collaborator

Study Sites (1)

Shriners Hospitals fof Children, Philadelphia

Philadelphia, Pennsylvania, 19140, United States

Location

Related Links

• Dr. Lee's research studies

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Samuel Lee, PT, PhD

  Physical Therapy Department, University of Delaware

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Associate Professor, Dept of Physical Therapy

Study Record Dates

• First Submitted: May 15, 2015
• First Posted: December 30, 2020
• Study Start: April 1, 2008
• Primary Completion: June 30, 2016
• Study Completion: June 30, 2016
• Last Updated: December 30, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Following publication of primary results.

Locations

US (1)