- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07310550
A Physical Therapy Program Targeting Lower Extremity Selective Motor Control in Children With Spastic Cerebral Palsy (CAMP LEG POWER)
Physical Therapy Program for Selective Motor Control
The goal of this intervention study is to learn whether a physical therapy exercise camp called will improve leg movement (motor control) and functional ability in children with spastic CP who are between 5 and 18 years. The main questions the study aims to answer are:
- Does the ability to move the knee at high velocities improve?
- Does function such as walking, running, hopping, climbing stairs improve?
- Will the brain tracts that control movement change?
- Will children who have better independent control of joint motion improve more?
All participants will:
- Attend 15 sessions of an exercise camp for 3 hours per day
- Perform a home exercise program after the camp ends
Measurements:
- Lower extremity selective motor control
- Knee muscle strength at high speeds using an exercise machine
- Gross motor function
- Gait analysis (walking patterns)
- Parent's perception of their child's ability and their satisfaction with that ability
- Change in brain motor tracts using a scanner (MRI) for participants that meet the inclusion criteria for MRI
MRI measurements will be taken twice (before and immediately after the treatment). All other measurements and will be taken 3 times (before, immediately after the treatment and approximately 4 months after the treatment).
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- Center for Cerebral Palsy at UCLA/Orthopaedic Institute for Children
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- spastic cerebral palsy
- age between 5-18 years
- ability to walk at least 10 meters
- ability to follow simple verbal directions
Exclusion Criteria:
All participants
- botulinum toxin or serial casting within the preceding 3 months
- recent orthopedic or neurological surgery within the preceding 12 months
- uncontrolled seizures
For participants undergoing MRI
- inability to lie still
- incompatible metal implants
- baclofen pumps or shunts
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Participants who have the intervention
physical therapy exercise intervention
|
Children practices moving the joints of each lower leg independently.
In sitting, the thigh and trunk are secured to a seat and the lower leg to a moving arm that provides resistance at exercise velocities progressing up to a maximum of 300 deg/s.
With the child in sitting, the ankle is secured to a moving segment.
The child can control games such as tennis by dorsiflexing and plantar flexing their ankle at increasing velocities to meet the demands of the game.
The Canadian Occupational Performance Measure is used to identify functional goals.
Activities to address these goals are designed by physical therapists and practiced during camp.
Walking barefoot over sand and grass.
Foot and ankle sensory exploration using materials with various textures.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gross Motor Function Measure
Time Frame: nine months
|
Children are asked to perform functional activities including standing, walking, running, balancing and stair climbing.
The data are entered into a computer program to create a score ranging from 0-100.
A higher score indicates better function.
|
nine months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knee joint torque
Time Frame: nine months
|
Three repetitions of maximum effort knee extension and flexion torque are collected at 0-300 deg/s for the affected lower limbs.
Outcomes are the percent of knee joints that can produce measurable torque at each velocity and the peak joint torque that is produced.
|
nine months
|
|
Canadian Occupational Performance Measure
Time Frame: nine months
|
Parents/caregivers and children choose 5 activities that they would like to see improve as a result of this intervention.
The parent or caregiver rates how well their child currently performs that task and how satisfied they are with the performance of the task on a scale of 1-10 with 10 being the highest score.
|
nine months
|
|
Brain MRI - Diffusion tensor imaging
Time Frame: nine months
|
A brain MRI scan is obtained.
Tract based spatial statistics are performed from the scan to look for changes in individual voxels.
Higher values for fractional anisotropy are associated with improved tract integrity.
Lower values for radial and median diffusivity are associated with improved myelination.
|
nine months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Eileen G Fowler, PhD, PT, University of California, Los Angeles
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Musculoskeletal Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Muscular Diseases
- Muscle Hypertonia
- Neuromuscular Manifestations
- Brain Damage, Chronic
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Muscle Spasticity
- Cerebral Palsy
Other Study ID Numbers
- 14-0414
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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