Mobility Training to Improve Motor Behavior in Toddlers With or at Risk for Cerebral Palsy: A Pilot Study
| Status: | Completed |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/27/2019 |
| Start Date: | November 15, 2010 |
| End Date: | June 6, 2014 |
Mobility Training to Improve Motor Behavior in Toddlers With or at Risk for Cerebral Palsy - A Pilot Study
Background:
- People who have cerebral palsy often have difficulty walking and moving their legs.
Cerebral palsy is sometimes not identified until a child is almost 2 years of age, which
means that early motor skill development can be affected and can have repercussions for later
development. Studies in adults with neurological injuries (e.g., stroke, spinal cord injury)
have shown that it is important to start intensive therapy soon after the injury, and it may
be true that starting intensive therapy at a young age will be helpful for children with
cerebral palsy. Researchers are interested in testing the effectiveness of a special body
weight support system for mobility training in young children who have or are at risk for
cerebral palsy.
Objectives:
- To study the effectiveness of a mobility training program on the motor skills of young
children who have or are at risk for cerebral palsy.
Eligibility:
- Children between 12 and 36 months of age who have delayed motor skills and either have been
diagnosed with cerebral palsy or show evidence of spasticity or brain damage.
Design:
- This study involves two 6-week study phases: a baseline phase and a mobility training
program.
- Participants will be screened with a physical examination and medical history.
- During the baseline phase, participants will have mobility testing sessions once every 2
weeks. These tests will measure motor development and ability, including ease and speed
of walking.
- Participants' parents/guardians will receive a mobility sensor for the child to wear at
home for at least 6 hours (awake time) to measure activity and mobility levels outside
of the testing sessions.
- After 6 weeks of baseline testing, participants will have 6 weeks of mobility training
for 30 minutes 3 days per week. Training will involve motor tasks with weight support,
conducted by a pediatric physical therapist. Activities may include walking, climbing
inclines or steps, or squatting to reach toys. All sessions will be videotaped.
- To evaluate the effects of the therapy program, participants will have testing sessions
every 2 weeks.
- Parents/guardians will also complete questionnaires to provide feedback on the
effectiveness of the therapy program.
- People who have cerebral palsy often have difficulty walking and moving their legs.
Cerebral palsy is sometimes not identified until a child is almost 2 years of age, which
means that early motor skill development can be affected and can have repercussions for later
development. Studies in adults with neurological injuries (e.g., stroke, spinal cord injury)
have shown that it is important to start intensive therapy soon after the injury, and it may
be true that starting intensive therapy at a young age will be helpful for children with
cerebral palsy. Researchers are interested in testing the effectiveness of a special body
weight support system for mobility training in young children who have or are at risk for
cerebral palsy.
Objectives:
- To study the effectiveness of a mobility training program on the motor skills of young
children who have or are at risk for cerebral palsy.
Eligibility:
- Children between 12 and 36 months of age who have delayed motor skills and either have been
diagnosed with cerebral palsy or show evidence of spasticity or brain damage.
Design:
- This study involves two 6-week study phases: a baseline phase and a mobility training
program.
- Participants will be screened with a physical examination and medical history.
- During the baseline phase, participants will have mobility testing sessions once every 2
weeks. These tests will measure motor development and ability, including ease and speed
of walking.
- Participants' parents/guardians will receive a mobility sensor for the child to wear at
home for at least 6 hours (awake time) to measure activity and mobility levels outside
of the testing sessions.
- After 6 weeks of baseline testing, participants will have 6 weeks of mobility training
for 30 minutes 3 days per week. Training will involve motor tasks with weight support,
conducted by a pediatric physical therapist. Activities may include walking, climbing
inclines or steps, or squatting to reach toys. All sessions will be videotaped.
- To evaluate the effects of the therapy program, participants will have testing sessions
every 2 weeks.
- Parents/guardians will also complete questionnaires to provide feedback on the
effectiveness of the therapy program.
The purpose of this pilot study is to test the feasibility and effects of a functional
mobility training program on the motor ability and physical activity of young children who
are developmentally delayed and at risk for cerebral palsy (CP). The study includes a sample
of 10 participants between 12-36 months of age who have at least a 4 month motor delay and
are at risk for CP in a single-subject research design with repeated measures during baseline
and intervention phases. Participants will have biweekly assessments during the 6 week
baseline phase and the subsequent 6 week mobility training phase, followed by a final
assessment after 6 weeks of treatment withdraw. Assessments and training will occur in the
Functional and Applied Biomechanics (FAB) section. The mobility training program consists of
three days per week of 30 minute treatment sessions using dynamic body weight support during
a variety of functional motor tasks. Children will be assisted, but not limited, by the
dynamic weight support system while they are encouraged to participate in a variety of
age-appropriate mobility tasks. It is hypothesized that this system combined with the
functional activity practice will facilitate the development of postural control and
strength, and thereby improve walking ability. The primary outcome measures are completion
rate and gross motor ability as measured by the Gross Motor Function Measure (GMFM).
Secondary outcome measures include the amount of gross motor delay as measured by the Bayley
Motor Scale (BMS),, the Functional Mobility Scale (FMS), spatiotemporal gait measures, and
amount of physical activity in daily life. Results of this pilot study will be used to refine
the mobility training program, evaluate the appropriateness of the selected outcome measures,
and to provide preliminary data for a larger scale clinical trial.
mobility training program on the motor ability and physical activity of young children who
are developmentally delayed and at risk for cerebral palsy (CP). The study includes a sample
of 10 participants between 12-36 months of age who have at least a 4 month motor delay and
are at risk for CP in a single-subject research design with repeated measures during baseline
and intervention phases. Participants will have biweekly assessments during the 6 week
baseline phase and the subsequent 6 week mobility training phase, followed by a final
assessment after 6 weeks of treatment withdraw. Assessments and training will occur in the
Functional and Applied Biomechanics (FAB) section. The mobility training program consists of
three days per week of 30 minute treatment sessions using dynamic body weight support during
a variety of functional motor tasks. Children will be assisted, but not limited, by the
dynamic weight support system while they are encouraged to participate in a variety of
age-appropriate mobility tasks. It is hypothesized that this system combined with the
functional activity practice will facilitate the development of postural control and
strength, and thereby improve walking ability. The primary outcome measures are completion
rate and gross motor ability as measured by the Gross Motor Function Measure (GMFM).
Secondary outcome measures include the amount of gross motor delay as measured by the Bayley
Motor Scale (BMS),, the Functional Mobility Scale (FMS), spatiotemporal gait measures, and
amount of physical activity in daily life. Results of this pilot study will be used to refine
the mobility training program, evaluate the appropriateness of the selected outcome measures,
and to provide preliminary data for a larger scale clinical trial.
- INCLUSION CRITERIA:
1. 12-36 months of age
2. greater than or equal to 4 months of gross motor delay corrected for gestational
age (measured by Bayley Motor Scale)
3. Diagnosis of bilateral spastic cerebral palsy OR neurological evidence of
spasticity or brain damage
4. Ability to pull to stand at a surface without assistance
5. Cognitive ability to follow one-step commands
6. Availability to return to NIH CC with parent or caregiver for required treatment
and assessment sessions
EXCLUSION CRITERIA:
1. Unilateral cerebral palsy
2. Secondary orthopedic, neuromuscular or cardiovascular condition unrelated to CP
3. Greater than six months of independent walking experience
4. History of surgery or injury to the lower extremities in the past 6 months
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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