Spastic Diplegic Cerebral Palsy
Conditions
Keywords
cerebral palsy, spasticity, diplegia
Brief summary
The study proposes to determine if injections of BTX-A to the hamstring muscles result in measurable physiologic changes not observed with normal saline injections in children with spastic diplegic cerebral palsy who walk with a flexed-knee gait pattern.
Detailed description
This study proposes to: (1) to determine if injections of BTX-A to the hamstring muscles result in measurable physiologic (body structure and body function) changes not observed with normal saline injections, in children with spastic diplegic CP who walk with a flexed-knee gait pattern; (2) to assess whether physiologic changes translate into functional (activity and participation) improvements; (3) to evaluate family's perception of change in function, activity, participation, and quality of life. This study will demonstrate if BTX-A injected into overactive hamstring muscles of children with spastic cerebral palsy (CP) and a flexed-knee walking pattern has measurable effects across the spectrum of dimensions of disablement of the International Classification of Functioning, Disability, and Health (ICF). It is a multi-center, prospective, randomized, double-blind trial comparing results of injection of BTX- A and placebo saline in controls, into overactive hamstring muscles, using multiple outcomes measures. Temporal-spatial gait parameters, instrumented 3DGA kinematics, passive ROM, spasticity measurement with both Ashworth and Tardieu scales, muscle strength/control, Gross Motor Function Measurement (GMFM), Pediatric Outcomes Data Collection Instrument (PODCI), Gillette Functional Assessment Questionnaire (FAQ), 6-Minute Walk Test, and Goal Attainment Scale (GAS), assessing all ICF domains, will be collected at baseline and at 1 month, 3 months, and 6 months post-injection. Power analysis demonstrates the need to randomize 250 children (125 with BTX-A, 125 with saline), allowing for attrition. Nine participating hospitals will contribute patients.
Interventions
DRUGBotulinum Toxin A
Sponsors
University of Virginia
Washington University School of Medicine
Shriners Hospitals for Children
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Spastic cerebral palsy; 2. Bilateral lower extremity involvement; 3. Spasticity present in the hamstrings; 4. Flexed knee gait \>15 degrees by observation (OGS); 5. Age between 3 and 18 years old; ( 6. GMFCS Level I to Level IV; ( 7. Able to walk a minimum of 4 complete steps without resting with and without braces/shoes a minimum of 3 times; 8. Able to follow simple commands; 9. Cooperative with physicians and therapist; 10. Able to tolerate application of equipment to the skin.
Exclusion criteria
1. Rhizotomy surgery within the last 1 year; 2. Lower extremity surgical procedures (soft tissue or bony) within the past 1 year; 3. Currently implanted and operating Intrathecal Baclofen Pump (oral baclofen OK); 4. Lower extremity BTX-A injections within the past 6 months; 5. Multilevel BTX-A injections; 6. Gait trainer reliance; 7. Serial casting 3 months prior to or during study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3DGA Kinematics | — |
| Passive Range of Motion | — |
| Spasticity Measurement with AShworth and Tardieu Scales | — |
| Muscle Strength and Control | — |
Secondary
| Measure | Time frame |
|---|---|
| Gross Motor Function Measurement (GMFM) | — |
| Goal Attainment Scale (GAS) | — |
| Pediatric Outcomes Data Collection Instrument (PODCI) | — |
| Gillette Functional Assessment Questionnaire (GFAQ) | — |
| 6-Minute Walk Test | — |
Outcome results
None listed