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

Focus of Study:

Cerebral Palsy (CP) is a problem with the brain that can cause muscle weakness and spasticity to occur. Children and teens with CP may not be able to exercise without assistance. Some research has shown that electrical stimulation can be used to help make muscles stronger in children with CP. We would like to find out if this electrical stimulation can help children and teens ride a stationary tricycle. We are trying to
develop a better way for children with CP to exercise.

Purpose:

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.

Intervention:

Functional Electrical Stimulation

Study Type:

Randomized Controlled Trial

Study Design:

One group in the study will cycle using functional electrical stimulation to assist leg movement during pedaling. A second group will cycle using only their own leg power. A third group called a control group, will not participate in cycling exercise. Cycling exercise will be done at Shriners Hospital for Children® - Philadelphia or in your own home if equipment and research staff are available.

You will be asked to come to Shriners Hospital four times during the study for testing sessions that last 2-3 days. Indoor on-site parking and lodging can be provided. During the testing sessions, your child will complete cycling exercise tests, questionnaires, strength testing and walking tests to determine the effect of training on these measures.

Groups:

1) FES

2) Volitional

3) Control

Inclusion Criteria:

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1) 10-18 years of age

2) The diagnosis of spastic diplegic or quadriplegic CP

3) Classified as Level II (walks without an assistive device, but with some limitations outdoors or in the community), Level III (uses an assistive mobility device or a wheelchair for long distances or Level IV (primarily uses a wheelchair for mobility) according to the Gross Motor Function Classification System (see Appendix A)

4) Sufficient covering of the femoral head in the acetabulum (MIGR% < 40%) and no significant scoliosis (primary curve >40 degrees).

5) Absence of severe tactile hypersensitivity in the lower extremities

6) Visuoperceptual skills and cognitive/communication skills sufficient to follow multiple step commands and to attend to tasks associated with data collection

7) The ability to maintain an upright position with minimal support and to sit for approximately one hour.

8) Adequate range of motion of the lower extremities in the hip, knee, and ankle to allow the child to complete a full revolution on the cycle

9) The willingness to participate in three training sessions per week for 8 weeks lasting approximately 1 hour each session (approximately 30 min of set up and up to 30 minutes of training) and to complete 2-3 days of testing during each assessment period (baseline, 8 weeks, 16 weeks) as well as a one day testing session four weeks into the training period. All testing will take place at Shriners Hospitals for Children, Philadelphia

10) The ability to obtain parental/guardian consent and child assent

Exclusion Criteria:

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1) Diagnosis of athetoid or ataxic CP

2) Lower extremity joint pain during cycling

3) Spinal fusion that extends to the pelvis

4) Hip, knee, or ankle joint instability or dislocation

5) History of lower limb stress fractures in the past year

6) Pulmonary disease limiting exercise tolerance

7) Symptomatic or known cardiac disease

8) History of surgery or traumatic fracture to the lower extremities within the past year or Botox injections to the lower extremity muscles within the past 6 months.

9) Severe spasticity in legs (score of 4 on the Modified Ashworth scale

10) Severely limited range of joint motion/irreversible muscle contractures that prevent the subject from being able to be safely positioned on the cycle.

11) Presence of an uncontrolled seizure disorder

Contacts:

Principal Investigator: Samuel Lee, PT, PhD

sclee@shrinenet.org

Research Physical Therapist: Henry Wright, PT

hwright@shrinenet.org

Research Assistant: Melissa Torres

metorres@shrinenet.org

Locations:

Shriners Hospital for Children

3551 North Broad Street

Philadelphia, PA 19140