Motion Analysis of Sit-to-Stand Movements in Children With Spastic Diplegia
Primary Purpose
Cerebral Palsy
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
loaded sit-to-stand training
Sponsored by
About this trial
This is an interventional educational/counseling/training trial for Cerebral Palsy focused on measuring cerebral palsy, resistance, movement, biomechanics
Eligibility Criteria
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
Sites / Locations
- National Taiwan University Hospital
Outcomes
Primary Outcome Measures
kinematic measures of lower extremity and the whole body
kinetic measures of lower extremity and the whole body
electromyographic measures of lower extremity and the whole body
Secondary Outcome Measures
Full Information
NCT ID
NCT00314301
First Posted
April 12, 2006
Last Updated
April 14, 2006
Sponsor
Far Eastern Memorial Hospital
Collaborators
National Taiwan University
1. Study Identification
Unique Protocol Identification Number
NCT00314301
Brief Title
Motion Analysis of Sit-to-Stand Movements in Children With Spastic Diplegia
Official Title
Motion Analysis of Sit-to-Stand Movements in Children With Spastic Diplegia Before and After Loaded Sit-to-Stand Training
Study Type
Interventional
2. Study Status
Record Verification Date
April 2006
Overall Recruitment Status
Unknown status
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Far Eastern Memorial Hospital
Collaborators
National Taiwan University
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to compare movement variations before and after the loaded training, with kinematics, kinetics, and electromyography, in children with spastic diplegia and to further discuss mechanisms of the loaded training.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
cerebral palsy, resistance, movement, biomechanics
7. Study Design
Primary Purpose
Educational/Counseling/Training
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
loaded sit-to-stand training
Primary Outcome Measure Information:
Title
kinematic measures of lower extremity and the whole body
Title
kinetic measures of lower extremity and the whole body
Title
electromyographic measures of lower extremity and the whole body
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuh-Ting Lin, MSc
Phone
866-2-8966-7000
Ext
1411
Email
yuh_ting_lin@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jao-Shwann Liang, MD
Phone
866-2-8966-7000
Ext
1411
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuh-Ting Lin, MSc
Organizational Affiliation
Research Ethics Review Committee of the Far Eastern Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hua-Fang Liao, MPH
Phone
886-2-3322\8136
Email
hfliao@ntu.edu.tw
First Name & Middle Initial & Last Name & Degree
Yuh-Ting Lin, MSc
12. IPD Sharing Statement
Learn more about this trial
Motion Analysis of Sit-to-Stand Movements in Children With Spastic Diplegia
We'll reach out to this number within 24 hrs