Cerebral PalsyNCT00314301
Motion Analysis of Sit-to-Stand Movements in Children With Spastic Diplegia
A study testing loaded sit-to-stand training in people with Cerebral Palsy, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- loaded sit-to-stand training
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2006to Sep 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Jao-Shwann Liang, MD contact
Taiwan1 site
National Taiwan University Hospital
Taipei, 100
Hua-Fang Liao, MPH, 886-2-3322\8136, hfliao@ntu.edu.tw
Yuh-Ting Lin, MSc
About this study
Official title: Motion Analysis of Sit-to-Stand Movements in Children With Spastic Diplegia Before and After Loaded Sit-to-Stand Training
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.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- loaded sit-to-stand training
- Keywords
- cerebral palsy, resistance, movement, biomechanics
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
loaded sit-to-stand trainingDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2006 (estimated)
- Study startApr 2006
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University
- Investigators
- Yuh-Ting Lin, MSc, Principal investigator, Research Ethics Review Committee of the Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00314301
- Sponsor's protocol ID
- 94023
- Status last verified
- Apr 2006
- First submitted
- 12 Apr 2006
- Last updated
- 17 Apr 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motion Analysis of Sit-to-Stand Movements in Children With Spastic Diplegia Before and After Loaded Sit-to-Stand Training
- ClinicalTrials.gov ID
- NCT00314301
- Acronym / sponsor ID
- 94023
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, resistance, movement, biomechanics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Collaborators
- National Taiwan University
- Study start
- Apr 2006
- Study completion
- Sep 2007
- First posted
- 13 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| loaded sit-to-stand training | Device | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jao-Shwann Liang, MD contact
Yuh-Ting Lin, MSc principal investigator
Research Ethics Review Committee of the Far Eastern Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing loaded sit-to-stand training in people with Cerebral Palsy, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuh-Ting Lin, MSc (866-2-8966-7000 ext. 1411, yuh_ting_lin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
kinematic measures of lower extremity and the whole body. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2006.