The Effects of Electrical Stimulation Gait Training on Walking and Posture for Children With Cerebral Palsy
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| First Received Date ICMJE | February 15, 2006 | ||||||||
| Last Updated Date | February 4, 2008 | ||||||||
| Start Date ICMJE | June 2005 | ||||||||
| Primary Completion Date | January 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Gait Kinematics, Spatial Temporal Parameters &Interjoint coordination, Standing Center of Pressure Variables, Canadian Occupational Performance Measurement, Muscle activation and timing, Timed up and go test, Functional Reach test | ||||||||
| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00292786 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The Effects of Electrical Stimulation Gait Training on Walking and Posture for Children With Cerebral Palsy | ||||||||
| Official Title ICMJE | Electrical Stimulation Gait Training to Effect Improvements in Walking Function and Posture for Children With Cerebral Palsy | ||||||||
| Brief Summary | This proposal is designed to achieve the following specific aims and will test the associated hypotheses: AIM 1: To compare walking ability, standing posture, gait initiation and functional standing and stepping of twenty children with typical development to that of twenty children with spastic diplegia or hemiplegia, CP. Hypotheses
AIM 2: Using a single-blinded, randomized, controlled study design, to assess the ability of a 12-week at-home electrical stimulation gait training program to improve walking ability, standing posture, gait initiation, functional standing and stepping, and satisfaction with walking ability for a group of 10 children with spastic diplegia or hemiplegia CP as compared to a group of 10 children with spastic diplegia or hemiplegia CP who undergo a 12-week at-home gait training program without electrical stimulation. Hypotheses
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| Detailed Description | This is a single blinded, randomized, controlled pre-test/post-test study design (Figure 4). The twenty children with spastic diplegia or hemiplegia CP will be randomized by a statistician to one of two treatment groups. One group will undergo a 12-week at-home gait training program with ES, subjects/guardians can choose either the surface or percutaneous stimulation subgroup, and the second group will undergo a 12-week at-home gait training program without ES. For both groups, data will be collected at five points: just before gait training, after 4 and 8 weeks of gait training, at the conclusion of gait training (after 12 weeks), and 4 weeks after gait training has been discontinued (16 weeks post initiation of gait training). Data collection at each follow-up point will include the kinetics and kinematics of walking, standing posture, gait initiation, plantar pressures, the administration of the Timed Up & Go and Functional Reach Test, and the assessment of lower extremity muscle strength using a hand-held dynamometer. The Canadian Occupational Performance Measure (COPM) will be applied before and after the 12-week gait training program and 4 weeks after the gait training has been discontinued. For the 20 children with typical development, the same data will be collected (except for the COPM) and used for comparison to the pre-training data collected from all 20 children with CP. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment |
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| Condition ICMJE | Cerebral Palsy | ||||||||
| Intervention ICMJE |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Estimated Enrollment ICMJE | 60 | ||||||||
| Completion Date | January 2008 | ||||||||
| Primary Completion Date | January 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 7 Years to 14 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00292786 | ||||||||
| Other Study ID Numbers ICMJE | 8520, 4365 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Not Provided | ||||||||
| Study Sponsor ICMJE | Shriners Hospitals for Children | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Shriners Hospitals for Children | ||||||||
| Verification Date | February 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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