Physical, Functional and Neural Effects of Two Lower Extremity Exercise Protocols in Children With Cerebral Palsy
| Status: | Completed |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 5 - 17 |
| Updated: | 12/21/2018 |
| Start Date: | March 5, 2010 |
| End Date: | May 9, 2016 |
Physical, Functional and Neurological Effects of Two Lower Extremity Exercise Programs in Children With Cerebral Palsy
Background:
- Many people who have cerebral palsy (CP) have spastic diplegia, which affects the legs
and causes difficulty with leg movement and walking. Research has shown that exercise
can help those with CP learn to move their arms better, but more research is needed to
determine whether exercise programs can improve leg movements in people with CP.
- Walking on a treadmill with the help of a physical therapist has improved the treatment
outcomes of some individuals with spinal cord injuries. Many children with CP already
have physical therapy but still have trouble with walking and leg coordination. Two
other kinds of exercise machines, a stationary bicycle and an elliptical machine, used
in the home, may be able to help children with CP walk better and move their legs
better.
Objectives:
- To see how children with cerebral palsy (CP) move their legs differently from children
without CP.
- To see if an exercise program can improve leg coordination in children with CP.
Eligibility:
- Children between 5 and 17 years of age who either have spastic diplegia CP or are healthy
volunteers.
Design:
- Children who are able and willing will have magnetic resonance imaging (MRI) scans at
the start and the end of the study.
- During Part I of the study, participants will demonstrate their leg and muscle function
with the following tests:
- Measurement of leg size and movement
- Combined camera motion study and electrical impulse evaluation to assess how well the
participant walks (with or without an assistive device, as needed)
- Leg movement tests on an exercise bicycle and elliptical machine
- Tests of leg muscle strength, stiffness, and effectiveness
- Ultrasound scans of leg muscle
- Parents of participants will complete computer-based questionnaires about their child s
motor abilities.
- A smaller group of participants will continue to Part II of the study, which involves
regular exercise of 20 minutes a day, 5 days a week, for 3 months, on a stationary
bicycle or elliptical trainer. Half of the group will start this exercise program
immediately after the first part of the study, while the other half will wait 3 months
before beginning the exercise program.
- During Part II, participants will return to the clinical center for two more sets of the
tests and evaluations performed in Part I.
- Many people who have cerebral palsy (CP) have spastic diplegia, which affects the legs
and causes difficulty with leg movement and walking. Research has shown that exercise
can help those with CP learn to move their arms better, but more research is needed to
determine whether exercise programs can improve leg movements in people with CP.
- Walking on a treadmill with the help of a physical therapist has improved the treatment
outcomes of some individuals with spinal cord injuries. Many children with CP already
have physical therapy but still have trouble with walking and leg coordination. Two
other kinds of exercise machines, a stationary bicycle and an elliptical machine, used
in the home, may be able to help children with CP walk better and move their legs
better.
Objectives:
- To see how children with cerebral palsy (CP) move their legs differently from children
without CP.
- To see if an exercise program can improve leg coordination in children with CP.
Eligibility:
- Children between 5 and 17 years of age who either have spastic diplegia CP or are healthy
volunteers.
Design:
- Children who are able and willing will have magnetic resonance imaging (MRI) scans at
the start and the end of the study.
- During Part I of the study, participants will demonstrate their leg and muscle function
with the following tests:
- Measurement of leg size and movement
- Combined camera motion study and electrical impulse evaluation to assess how well the
participant walks (with or without an assistive device, as needed)
- Leg movement tests on an exercise bicycle and elliptical machine
- Tests of leg muscle strength, stiffness, and effectiveness
- Ultrasound scans of leg muscle
- Parents of participants will complete computer-based questionnaires about their child s
motor abilities.
- A smaller group of participants will continue to Part II of the study, which involves
regular exercise of 20 minutes a day, 5 days a week, for 3 months, on a stationary
bicycle or elliptical trainer. Half of the group will start this exercise program
immediately after the first part of the study, while the other half will wait 3 months
before beginning the exercise program.
- During Part II, participants will return to the clinical center for two more sets of the
tests and evaluations performed in Part I.
Objectives:
Our primary objectives are to: 1) characterize and compare lower extremity motor coordination
in children with cerebral palsy (CP) across mobility levels and to children without CP; and
2) evaluate the effects of two home-based exercise programs on motor coordination, as well as
other physical, functional and neurological outcomes in children with CP. We hypothesize
children with CP will exhibit significant coordination deficits compared to those without CP
and that each exercise program will lead to significant improvements in outcomes.
Study Population:
Objective 1 will include 60 ambulatory children with spastic diplegic CP (20 in each of three
mobility levels) and 20 children without CP within the same age range. Forty (40) children
with CP will participate in Objective 2; 20 in each exercise group.
Design:
In Objective 1, the multiple measures taken at a single point in time will be compared across
the three CP and the control groups. Children with CP from Objective 1 will be invited
consecutively to participate in the exercise program (Objective 2), until enrollment is
complete. Participation in Objective 2 lasts for 6 months. Subjects will be randomly assigned
to use one of two novel lower extremity exercise devices: a motor-assisted cycle or an
elliptical trainer. Children will exercise for 20 minutes, 5 days a week for 12 consecutive
weeks. The major goal of each is to increase the ability to cycle or step at a rapid pace
(the target goal is 40 RPM), with resistance added once speed goals are attained and
thereafter progressed gradually. The timing of the exercise period (immediate vs. delayed for
3 months) will also be randomly assigned allowing assessors to be masked to group assignment.
Outcome Measures:
The primary outcome is the difference (Objective 1) or pre to post-exercise change (Objective
2) in coordination as measured by the fastest active (voluntary) cadence with each device.
Additional coordination measures include cadence at free speed, variability in cadence, and
EMG reciprocation vs. synchronization. Selective Control Assessment for the Lower extremity
(SCALE), strength and spasticity tests and ultrasound measures of muscle size will be
assessed at each time point. These will be compared across groups and before and after the
two exercise programs. Functional outcomes include gait speed and two validated
computer-based questionnaires. Neural outcomes include selected measures of gray and white
matter connectivity as assessed with fcMRI and DTI, respectively.
Our primary objectives are to: 1) characterize and compare lower extremity motor coordination
in children with cerebral palsy (CP) across mobility levels and to children without CP; and
2) evaluate the effects of two home-based exercise programs on motor coordination, as well as
other physical, functional and neurological outcomes in children with CP. We hypothesize
children with CP will exhibit significant coordination deficits compared to those without CP
and that each exercise program will lead to significant improvements in outcomes.
Study Population:
Objective 1 will include 60 ambulatory children with spastic diplegic CP (20 in each of three
mobility levels) and 20 children without CP within the same age range. Forty (40) children
with CP will participate in Objective 2; 20 in each exercise group.
Design:
In Objective 1, the multiple measures taken at a single point in time will be compared across
the three CP and the control groups. Children with CP from Objective 1 will be invited
consecutively to participate in the exercise program (Objective 2), until enrollment is
complete. Participation in Objective 2 lasts for 6 months. Subjects will be randomly assigned
to use one of two novel lower extremity exercise devices: a motor-assisted cycle or an
elliptical trainer. Children will exercise for 20 minutes, 5 days a week for 12 consecutive
weeks. The major goal of each is to increase the ability to cycle or step at a rapid pace
(the target goal is 40 RPM), with resistance added once speed goals are attained and
thereafter progressed gradually. The timing of the exercise period (immediate vs. delayed for
3 months) will also be randomly assigned allowing assessors to be masked to group assignment.
Outcome Measures:
The primary outcome is the difference (Objective 1) or pre to post-exercise change (Objective
2) in coordination as measured by the fastest active (voluntary) cadence with each device.
Additional coordination measures include cadence at free speed, variability in cadence, and
EMG reciprocation vs. synchronization. Selective Control Assessment for the Lower extremity
(SCALE), strength and spasticity tests and ultrasound measures of muscle size will be
assessed at each time point. These will be compared across groups and before and after the
two exercise programs. Functional outcomes include gait speed and two validated
computer-based questionnaires. Neural outcomes include selected measures of gray and white
matter connectivity as assessed with fcMRI and DTI, respectively.
- INCLUSION CRITERIA:
A. For those without CP (healthy volunteers)
1. Must be between the ages of 5-17, inclusive
2. Must be in good general health
3. Must be able to understand and comply with the requirements of the study
B. For those with CP
1. Must be between the ages of 5-17, inclusive
2. Have a diagnosis of spastic bilateral cerebral palsy
3. Documentation on previous MRI of peri-ventricular white matter injury
4. Able to walk at least 20 feet without stopping and without the need for assistance by
another person. A hand-held assistive device (e.g. cane, walker) may be used if
necessary.
5. Be able to understand and comply with the requirements of the study
6. Availability of an adult who agrees to be primarily responsible for completing the
reporting requirements for the study and supervising the exercise program
EXCLUSION CRITERIA:
A. For those without CP (healthy volunteers)
1. Have a history of musculoskeletal or neurological injury or disorder or general medical
condition that would affect the use of the legs or limit the ability to safely perform
motor testing
B. For those with CP:
1. Receiving oral or intrathecal baclofen, which may depress neural plasticity, at the
time of enrollment or during the study period
2. Had surgery to the lower extremities in the past year or any major surgery within the
past 6 months
3. Presence of any major medical illness that would limit the ability to safely tolerate
the exercise program
4. Requiring or desiring to have botulinum toxin injections within four months before or
at any time during the study period.
5. Requiring the use of a device that provides support of the pelvis when walking (e.g.
gait trainer)
6. If choosing to participate in the exercise program, cannot be currently using an
exercise machine or start using one during the study period.
ADDITIONAL EXCLUSION CRITERIA FOR THOSE HAVING A MRI:
1. Pregnancy: For any female of childbearing potential who is not pregnant, a pregnancy
test will be done.
2. A ventriculo-peritoneal shunt
3. Claustrophobia
4. Metal fragments, wires or implants in the brain or in any part of the skin or body
5. Excessive startle reaction to or fear of loud noises
6. Inability to remain still and quiet for up to five minutes at a time
7. Inability to be off levodopa for at least 24 hours
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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