- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00314301
Motion Analysis of Sit-to-Stand Movements in Children With Spastic Diplegia
Motion Analysis of Sit-to-Stand Movements in Children With Spastic Diplegia Before and After Loaded Sit-to-Stand Training
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Subjects: This study will recruit twenty children who are aged between 5 and 12 years, with spastic diplegia, and without having major surgeries or botulinum toxin injection on lower extremities during the past 6 months prior to participate in this study.
Methods: The Vicon 250 motion analysis system, 3 AMTI force platforms and the EMG recording system will be used to collect data of sit-to-stand (STS) movements. Baseline, pre- and post-training evaluations will be carried out. The duration of the baseline and pre-training evaluations is 2 months. The training period will take about 6 weeks. Each evaluation will take two separate days to accomplish. On the first day, the STS1RM of individual children was determined. On the second day, kinematic and kinetic data of STS movements in natural and loaded (applying load of 50% STS1RM during STS movements) conditions were collected. Data of smoothness, maximal extension moment and around hip and knee joints, onset time of lower extremity muscles will then be calculated. Results of each evaluation will be used for further comparison.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Taipei, Taiwan, 100
- National Taiwan University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosed as spastic diplegia
- Aged between 5 and 12 years
- Able to perform the STS movements without assistance
- Able to cooperate and understand commands given
Exclusion Criteria:
- Severe musculoskeletal deformity or pain on lower extremities
- Botulism injection in the past 3 months or major operations in the preceding 6 months on lower extremities
- Uncontrolled epilepsy
- Major sensory deficits, such as blindness or deafness
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Educational/Counseling/Training
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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kinematic measures of lower extremity and the whole body
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kinetic measures of lower extremity and the whole body
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electromyographic measures of lower extremity and the whole body
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Yuh-Ting Lin, MSc, Research Ethics Review Committee of the Far Eastern Memorial Hospital
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 94023
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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