Cerebral PalsyPhase 4NCT00154830
Alterations of Functional Activities and Leg Stiffness After Hamstring Lengthening in Cerebral Palsy Children
A Phase 4 study testing cerebral palsy and crouch gait in people with Cerebral Palsy and Crouch Gait, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Cerebral palsy (CP) is the most prevalent physical disabilities originating in childhood. Crouch gait is a common gait abnormality in patients with cerebral palsy, which is common treated with hamstring lengthening. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Crouch Gait
- What is being tested?
- cerebral palsy and crouch gait
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2004to Jul 2005
- Phase
- Phase 4
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- cerebral palsy
- couch gait
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Cerebral palsy (CP) is the most prevalent physical disabilities originating in childhood. Crouch gait is a common gait abnormality in patients with cerebral palsy, which is common treated with hamstring lengthening. This surgery can alter mechanical property of lower limb and affected ability of generating force in hamstring, leading changes in functional activities. Therefore, the first aim of this study is to investigate the effects of hamstring lengthening on pelvis and hip control while performing functional activity, including level walking and sit-to-stand.
Read the detailed description
Cerebral palsy (CP) is the most prevalent physical disabilities originating in childhood. Crouch gait is a common gait abnormality in patients with cerebral palsy, which is common treated with hamstring lengthening. This surgery can alter mechanical property of lower limb and affected ability of generating force in hamstring, leading changes in functional activities. Therefore, the first aim of this study is to investigate the effects of hamstring lengthening on pelvis and hip control while performing functional activity, including level walking and sit-to-stand.
Gait or motion analysis has been used widely in the diagnosis of patients with locomotor pathology and the subsequent planning and assessment of treatment. Ten subjects diagnosed with spastic diplegic cerebral palsy and crouch gait will be recruited and ten healthy controls will be recruited in this study with inform consents. Detailed physical examination and motion analysis experiments will be performed in normal group and in spastic diplegic patients before the hamstring lengthening and follow ip after six months. The subjects would be asked to perform level walking with self-selected pace and sit-to-stand from an armless chair. For each test, subjects would repeat at least 5 times, with their kinematic, kinetic and EMG data collected simultaneously. With thorough analysis and comparison of these data, it is hoped that a reference in clinical decision of hamstring lengthening can be established, and a complete knowledge of the effects after hamstring lengthening, which will be helpful for future clinical rehabilitation.
- Conditions
- Cerebral Palsy, Crouch Gait
- Being tested
- cerebral palsy, crouch gait
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cerebral palsyBehavioural
crouch gaitBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait
Sit-to-stand
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startAug 2004
- Study completionJul 2005
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.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ting-Ming Wang, MD, Study chair, Dept. of Orthopaedic, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00154830
- Sponsor's protocol ID
- 9200201507
- Status last verified
- Jul 2005
- First submitted
- 8 Sep 2005
- Last updated
- 23 Nov 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alterations of Functional Activities and Leg Stiffness After Hamstring Lengthening in Cerebral Palsy Children
- ClinicalTrials.gov ID
- NCT00154830
- Acronym / sponsor ID
- 9200201507
- Conditions
- Cerebral Palsy, Crouch Gait
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2004
- Study completion
- Jul 2005
- First posted
- 12 Sep 2005 (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.
Cerebral palsy (CP) is the most prevalent physical disabilities originating in childhood. Crouch gait is a common gait abnormality in patients with cerebral palsy, which is common treated with hamstring lengthening. This surgery can alter mechanical property of lower limb and affected ability of generating force in hamstring, leading changes in functional activities. Therefore, the first aim of this study is to investigate the effects of hamstring lengthening on pelvis and hip control while performing functional activity, including level walking and sit-to-stand.
Detailed description
Cerebral palsy (CP) is the most prevalent physical disabilities originating in childhood. Crouch gait is a common gait abnormality in patients with cerebral palsy, which is common treated with hamstring lengthening. This surgery can alter mechanical property of lower limb and affected ability of generating force in hamstring, leading changes in functional activities. Therefore, the first aim of this study is to investigate the effects of hamstring lengthening on pelvis and hip control while performing functional activity, including level walking and sit-to-stand.
Gait or motion analysis has been used widely in the diagnosis of patients with locomotor pathology and the subsequent planning and assessment of treatment. Ten subjects diagnosed with spastic diplegic cerebral palsy and crouch gait will be recruited and ten healthy controls will be recruited in this study with inform consents. Detailed physical examination and motion analysis experiments will be performed in normal group and in spastic diplegic patients before the hamstring lengthening and follow ip after six months. The subjects would be asked to perform level walking with self-selected pace and sit-to-stand from an armless chair. For each test, subjects would repeat at least 5 times, with their kinematic, kinetic and EMG data collected simultaneously. With thorough analysis and comparison of these data, it is hoped that a reference in clinical decision of hamstring lengthening can be established, and a complete knowledge of the effects after hamstring lengthening, which will be helpful for future clinical rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- cerebral palsy
- couch gait
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| cerebral palsy | Behavioural | – |
| crouch gait | Behavioural | – |
Primary outcome
Gait
Sit-to-stand
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2005.
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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.
Ting-Ming Wang, MD study chair
Dept. of Orthopaedic, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing cerebral palsy and crouch gait in people with Cerebral Palsy and Crouch Gait, run by National Taiwan University 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 23 Nov 2005. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait. The study lists 2 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 23 Nov 2005.