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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00467415 |
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Date of registration:
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27/04/2007 |
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Primary sponsor: |
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Public title:
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Supported Speed Treadmill Training Exercise Program (SSTTEP) for Marginally Ambulatory Children With Cerebral Palsy
SSTTEP |
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Scientific title:
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Multi-Center Project: Supported Speed Treadmill Training Exercise Program (SSTTEP) for Marginally Ambulatory Children With Cerebral Palsy |
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Date of first enrolment:
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May 2007 |
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Target sample size:
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66 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00467415 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Randal Betz, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Shriners Hospital for Children, Philadelphia |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. A diagnosis of spastic cerebral palsy;
2. Impaired ambulation abilities as evidenced by a decreased in gait velocity below 80%
of age expected value or gross motor function classification scale (GMFCS) Level III
or IV;
3. Able to ambulate independently for 8 steps with/without assistive devices to allow
for adequate motion analysis data collection;
4. Body weight of less than 150 pounds;
5. Between the ages of 6 and 13 years;
6. Able to follow multiple step commands and to attend to tasks associated with data
collection;
7. Willingness to travel to one of the three sites for data collection sessions, and 2
weeks of intensive intervention;
8. Willingness to commit to home program 30 minutes per session, 5 times week for 10
weeks, as well as adequate space and supervision for treadmill use at home;
9. No reported musculoskeletal, cardiovascular or pulmonary conditions that would limit
participation in moderate exercise program;
10. Minimum of 12 months post surgery including soft tissue releases
11. Six months post-Botox injections, significant changes in Baclofen dosing, or casting
procedures to the lower extremities;
12. Passive range of motion of lower extremity joints: < 30º contracture of hip in
extension as measured by the Thomas Test; passive dorsiflexion range of motion to
-15º with the knee extended, and knee extension range (90º/90º test) to 70º and <-20º
knee extension.
13. At least 2 years post- dorsal rhizotomy.
Exclusion Criteria:
1. Children with "mixed" types of CP (i.e. athetosis) or other movement disorders (e.g.
ataxia);
2. Children receiving intrathecal Baclofen (baclofen pump);
Age minimum:
6 Years
Age maximum:
13 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cerebral Palsy
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Intervention(s)
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Behavioral: Exercise
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Behavioral: Partial body weight support treadmill training
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Primary Outcome(s)
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Canadian Occupational Performance Measure (COPM)
[Time Frame: 6 months]
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Children's Assessment of Participation and Enjoyment (CAPE)
[Time Frame: 6 months]
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Gait Spatio-Temporal Parameters
[Time Frame: 6 months]
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Gait Velocity
[Time Frame: 6 months]
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Gross Motor Function Measure (GMFM)
[Time Frame: 6 months]
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Muscle Activation and Timing
[Time Frame: 6 months]
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Pediatric Outcomes Data Collection Instrument (PODCI)
[Time Frame: 6 months]
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Pediatric Quality of Life Inventory (PEDS-QL)
[Time Frame: 6 months]
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Piers-Harris Children's Self-Concept Scale, 2nd Edition (PHCSCS-2)
[Time Frame: 6 months]
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Secondary ID(s)
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SHC_COSAB9147
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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