Efficacy and Functional Outcomes of Botulinum Toxin A Injections to Hamstrings in Flexed Knee Gait in Cerebral Palsy

Spastic Diplegic Cerebral Palsy Clinical Trial

Official title:

Efficacy and Functional Outcomes of Botulinum Toxin A Injections to Hamstrings in Flexed Knee Gait in Cerebral Palsy: A Double-Blind, Randomized, Placebo-Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00261131
• Other study ID #: 9199
• Status: Completed
• Phase: Phase 3
• First received: November 30, 2005
• Last updated: February 4, 2009
• Start date: March 2006
• Est. completion date: December 2007

Study information

• Verified date: February 2009
• Source: Shriners Hospitals for Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 18 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy
• Spastic Diplegic Cerebral Palsy

Intervention

Drug:
• Botulinum Toxin A

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Shriners Hospitals for Children	University of Virginia, Washington University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3DGA Kinematics
Primary	Passive Range of Motion
Primary	Spasticity Measurement with AShworth and Tardieu Scales
Primary	Muscle Strength and Control
Secondary	Gross Motor Function Measurement (GMFM)
Secondary	Pediatric Outcomes Data Collection Instrument (PODCI)
Secondary	Gillette Functional Assessment Questionnaire (GFAQ)
Secondary	6-Minute Walk Test
Secondary	Goal Attainment Scale (GAS)