FES Assisted Cycling in Children With CP - Clinical Trial for Cerebral Palsy Spastic Diplegia | NCT04688424

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

FES

Cycling

About this trial

This is an interventional treatment trial for Cerebral Palsy Spastic Diplegia focused on measuring Cerebral Palsy, Functional electrical stimulation, Cycling

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

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 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

Sites / Locations

Shriners Hospitals fof Children, Philadelphia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

FES + Cycling

Cycling only

Control

Arm Description

Functional electrical stimulation cycling group

Volitional cycling group (no electrical stimulation)

control group

Outcomes

Primary Outcome Measures

Change in cycling Ability

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04688424

First Posted

May 15, 2015

Last Updated

December 24, 2020

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborators

Shriners Hospitals for Children

1. Study Identification

Unique Protocol Identification Number

NCT04688424

Brief Title

FES Assisted Cycling in Children With CP

Acronym

CP FES Cycling

Official Title

Functional Electrical Stimulation Assisted Cycling to Improve Fitness and Strength in Children With Cerebral Palsy

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

April 2008 (undefined)

Primary Completion Date

June 30, 2016 (Actual)

Study Completion Date

June 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborators

Shriners Hospitals for Children

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

No

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Aim 1: To compare the effects of 8-weeks of FES-assisted cycling training on improving cardiorespiratory fitness, walking function, self-motivated exercise/recreation, self-perception and functional mobility and quality of life of adolescents with spastic CP with marginal walking ability (Gross Motor Function Classification System Levels II - IV) vs. 8-weeks of volitional cycling training and a non-intervention control group. Aim 2: To compare the effects of 8-weeks FES-assisted cycling training on changes in cycling ability of adolescents with spastic CP with marginal walking ability vs. 8-weeks of volitional cycling training and a nonintervention control group. Aim 3: To elucidate the mechanisms for potential improvements in cycling ability after 8-weeks of FES-assisted or volitional cycling training of adolescents with spastic CP and marginal walking ability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Palsy Spastic Diplegia

Keywords

Cerebral Palsy, Functional electrical stimulation, Cycling

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FES + Cycling

Arm Type

Experimental

Arm Description

Functional electrical stimulation cycling group

Arm Title

Cycling only

Arm Type

Active Comparator

Arm Description

Volitional cycling group (no electrical stimulation)

Arm Title

Control

Arm Type

No Intervention

Arm Description

control group

Intervention Type

Device

Intervention Name(s)

FES

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Cycling

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in cycling Ability

Description

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

Time Frame

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

Title

Change in Energy Expenditure

Description

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.

Time Frame

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

Title

Change in Gait speed

Description

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.

Time Frame