Supported Speed Treadmill Training Exercise Program (SSTTEP) for Marginally Ambulatory Children With Cerebral Palsy (SSTTEP)
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|ClinicalTrials.gov Identifier: NCT00467415|
Recruitment Status : Unknown
Verified August 2008 by Shriners Hospitals for Children.
Recruitment status was: Active, not recruiting
First Posted : April 30, 2007
Last Update Posted : June 29, 2009
The investigators are studying the effects of a 12-week exercise program, consisting of either:
- Walking on a treadmill with partial body weight
- Functional exercise program
The investigators would like to know the effects these two exercise programs have on the quality of life, muscle strength and control, coordination, walking, and functional movement of children with cerebral palsy who are marginal ambulators. This is a randomized control trial with subjects randomly assigned to one of the 2 groups.Subjects in both groups will be seen twice a day for two weeks at our hospital for intervention and parent training, and then participate in a 10 week home-based program. During each subject's two-week clinic-based training, a parent or caregiver is trained in all home program exercises and/or equipment usage. This person must be able to safely perform the exercise program with the child. Each subject will also need to participate in three separate 5-hour long data collection sessions scheduled over the 4 month study period.
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Palsy||Behavioral: Partial body weight support treadmill training Behavioral: Exercise||Not Applicable|
This project proposes to answer the following questions: Is partial body weight supported treadmill gait training (PBWSTT) effective in improving ambulation abilities, neuromuscular impairments, functional mobility, disability, and quality of life in marginally ambulatory children with cerebral palsy.
Specific Aim 1: Assess the effect of a PBWSTT locomotor training intervention on quality of life, treatment expectations, self-efficacy, and activity and participation of children with CP with limited ambulation skills. We hypothesize that in comparison to a control group, after a 12 week locomotor intervention, children with CP (intervention group) with limited ambulation skills will demonstrate greater improvements in scores from common questionnaires compared to the control group.
Specific Aim 2: Assess the effect of a PBWSTT locomotor training intervention on gross motor skills; physical function; biomechanics and coordination dynamics of ambulation; and physical activity in ambulatory children with CP. We hypothesize that in comparison to a control group, after a 12 week PBWSTT locomotor training intervention children with CP with limited ambulation skills will demonstrate greater improvements in functional test scores compared to the control group.
Specific Aim 3: Assess the effect of a PBWSTT locomotor training intervention on measures of body structure and function including: spasticity; muscle strength; and joint-specific motor control. We hypothesize that in comparison to a control group, after a 12 week PBWSTT locomotor training intervention children with CP with limited ambulation skills will demonstrate greater improvements in: muscle strength, spasticity and joint specific motor control compared to the control group.
This is a single blinded, randomized, controlled pre-test/post-test study design. Sixty six ambulatory children between the ages of 6-12 years of age with cerebral palsy will undergo a 12-week training program. Thirty three of these children will undergo a Supported Speed Treadmill Training Exercise Program (SSTTEP), and the remaining 33 children will receive the same amount of conventional physical therapy in the form of a personalized home exercise program and serve as a control group. Three sets of measures will be obtained: A1) at baseline prior to intervention; A2) at the end of the 12-week intervention period; and A3) 4 weeks after the intervention has ended.
The two primary aims of our study are to assess the efficacy of SSTTEP in improving quality of life, functional ambulation, energy expenditure, gross motor skills, and muscle strength and tone; and to assess the efficacy of SSTTEP in improving the coordination of stepping and ambulation in children with CP.
The intervention group will undergo a program of 10 hours of intensive SSTTEP training over a 14 day period. After the initial training, the subjects will participate in a home program of 30 minutes/5 times per week for an additional 10 weeks.
The control group with undergo a personalized exercise program consisting of 10 hours of intensive training over a 14 day period. After the initial training, the subjects will participate in a home program of 30 minutes/5 times per week for an additional 10 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Multi-Center Project: Supported Speed Treadmill Training Exercise Program (SSTTEP) for Marginally Ambulatory Children With Cerebral Palsy|
|Study Start Date :||May 2007|
|Estimated Primary Completion Date :||October 2009|
|Estimated Study Completion Date :||December 2009|
- Behavioral: Partial body weight support treadmill training
Treadmill ambulation for 12 weeks. First 2 weeks for 10 total dose hours within clinical setting, final 10 weeks with 30 min/5 times week.
- Behavioral: Exercise
Functional Strengthening exercise program for 12 weeks. First 2 weeks for 10 total dose hours within clinical setting, final 10 weeks with 30 min/5 times week.
- Gait Spatio-Temporal Parameters [ Time Frame: 6 months ]
- Muscle Activation and Timing [ Time Frame: 6 months ]
- Pediatric Quality of Life Inventory (PEDS-QL) [ Time Frame: 6 months ]
- Canadian Occupational Performance Measure (COPM) [ Time Frame: 6 months ]
- Children's Assessment of Participation and Enjoyment (CAPE) [ Time Frame: 6 months ]
- Piers-Harris Children's Self-Concept Scale, 2nd Edition (PHCSCS-2) [ Time Frame: 6 months ]
- Gross Motor Function Measure (GMFM) [ Time Frame: 6 months ]
- Pediatric Outcomes Data Collection Instrument (PODCI) [ Time Frame: 6 months ]
- Gait Velocity [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00467415
|United States, Louisiana|
|Shriners Hospital for Children, Shreveport|
|Shreveport, Louisiana, United States, 71103|
|United States, Missouri|
|St. Louis, Missouri, United States, 63104|
|United States, Pennsylvania|
|Shriners Hospital for Children, Philadelphia|
|Philadelphia, Pennsylvania, United States, 19140|
|Principal Investigator:||Randal Betz, MD||Shriners Hospital for Children, Philadelphia|