Cerebral PalsyNCT00462085
Muscle Activity With the Use of Ankle Foot Orthoses in Cerebral Palsy
An observational study of Cerebral Palsy, run by University Children's Hospital Basel at 1 site in Switzerland.
Trial summary
The purpose of this study is to investigate the change in muscle activity during gait with the use of ankle foot orthoses in children diagnosed with hemiplegic cerebral palsy. Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2004to Apr 2007
- Phase
- Observational
- 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 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- clinical diagnosis of spastic hemiplegic cerebral palsy
- age between 8 and 18 years
- must have an equinus barefoot gait pattern
- must have a heel-toe gait pattern with ankle foot orthosis
- no prior operations
Who cannot join
- no Botulinumtoxin treatment for at least 6 months prior to investigation
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Laboratory for Movement Analysis
Basel, Canton of Basel-City, CH-4055
About this study
The purpose of this study is to investigate the change in muscle activity during gait with the use of ankle foot orthoses in children diagnosed with hemiplegic cerebral palsy.
Read the detailed description
A small group of children with hemiplegic cerebral palsy is investigated by 3D instrumented gait analysis. Muscle activity is measured by surface electromyography (sEMG) of selected lower limb muscle groups. Kinematic, Kinetic, and sEMG data are compared between both lower limbs walking with and without an ankle foot orthosis. Data are also compared with those of an healthy control group.
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, ankle foot orthosis, emg, surface electromyography, gait analysis
- Medical subject headings
- Cerebral Palsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2007 (estimated)
- Study startSep 2004
- Study completionApr 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
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- University Children's Hospital Basel
- Sponsor type
- University, hospital or other
- Investigators
- Reinald Brunner, Prof.Dr.med., Study director, University Children's Hospital BaselJacqueline Romkes, M.Sc., Principal investigator, University Children's Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00462085
- Sponsor's protocol ID
- 94/04
- Status last verified
- Apr 2007
- First submitted
- 17 Apr 2007
- Last updated
- 18 Apr 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Activity With the Use of Ankle Foot Orthoses in Cerebral Palsy
- ClinicalTrials.gov ID
- NCT00462085
- Acronym / sponsor ID
- 94/04
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, ankle foot orthosis, emg, surface electromyography, gait analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- University Children's Hospital BaselUniversity, hospital or other
- Study start
- Sep 2004
- Study completion
- Apr 2007 (actual)
- First posted
- 18 Apr 2007 (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 investigate the change in muscle activity during gait with the use of ankle foot orthoses in children diagnosed with hemiplegic cerebral palsy.
Detailed description
A small group of children with hemiplegic cerebral palsy is investigated by 3D instrumented gait analysis. Muscle activity is measured by surface electromyography (sEMG) of selected lower limb muscle groups. Kinematic, Kinetic, and sEMG data are compared between both lower limbs walking with and without an ankle foot orthosis. Data are also compared with those of an healthy control group.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- clinical diagnosis of spastic hemiplegic cerebral palsy
- age between 8 and 18 years
- must have an equinus barefoot gait pattern
- must have a heel-toe gait pattern with ankle foot orthosis
- no prior operations
Key exclusion criteria (1 listed)
- no Botulinumtoxin treatment for at least 6 months prior to investigation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 18 Apr 2007.
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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.
Reinald Brunner, Prof.Dr.med. study director
University Children's Hospital Basel
Jacqueline Romkes, M.Sc. principal investigator
University Children's Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by University Children's Hospital Basel at 1 site in Switzerland.
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 5 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 18 Apr 2007. 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 Switzerland. 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?
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.
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 18 Apr 2007.