Cerebral PalsyNCT00552721
Physical Therapy After Anti-spastic Treatment in Children With Cerebral Palsy
A study testing Physical therapy with strength training and Physical therapy without strength training in people with Cerebral Palsy, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
It is the primary purpose of this pilot study to investigate if physical therapy with strength training is better at improving muscle and gait function after anti-spastic treatment with Botulinum toxin compared to physical therapy without strength training in children with cerebral palsy. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Physical therapy with strength training and Physical therapy without strength training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2007to Jul 2009
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- cerebral palsy (diplegia and hemiplegia)
- indication for anti-spastic treatment with Botulinum toxin
Who cannot join
- fixed contractures
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Gait Analysis Laboratory, Department of Orthopedic Surgery, Hvidovre University Hospital
Hvidovre, DK-2650
About this study
Official title: Physical Therapy With Versus Without Strength Training After Botulinum-toxin Treatment in Children With Cerebral Palsy
It is the primary purpose of this pilot study to investigate if physical therapy with strength training is better at improving muscle and gait function after anti-spastic treatment with Botulinum toxin compared to physical therapy without strength training in children with cerebral palsy. The investigators hypothesize that it is.
- Conditions
- Cerebral Palsy
- Being tested
- Physical therapy with strength training, Physical therapy without strength training
- Keywords
- Motor control, Spasticity
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapy with strength trainingOther
12 weeks of physical therapy after Botulinum-toxin treatment (two 45-min sessions/week) with an emphasis on strength training.
Physical therapy without strength trainingOther
12 weeks of physical therapy after Botulinum-toxin treatment (two 45-min sessions/week) without strength training.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Physical therapy with strength training. Receives: Other: Physical therapy with strength training |
| B | Active comparator | Physical therapy without strength training. Receives: Other: Physical therapy without strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Three-dimensional gait analysis
Measured: 12 weeks
Selective motor control
Measured: 12 weeks
Secondary outcomes (2)
Spasticity (modified Ashworth)
Measured: 12 weeks
Range of motion
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2007 (estimated)
- Study startOct 2007
- Study completionJul 2009
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Thomas Bandholm, MSc, Principal investigator, Gait Analysis Laboratory, Department of Orthopedic Surgery, Hvidovre University HospitalStig Sonne-Holm, MD, DSc, Study chair, Gait Analysis Laboratory, Department of Orthopedic Surgery, Hvidovre University HospitalBente R Jensen, PhD, Study chair, Institute of Exercise and Sport Sciences, University of CopenhagenSøren A Pedersen, MD, Study chair, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00552721
- Sponsor's protocol ID
- KF 02 323948
- Status last verified
- Sep 2009
- First submitted
- 31 Oct 2007
- Last updated
- 7 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Therapy With Versus Without Strength Training After Botulinum-toxin Treatment in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT00552721
- Acronym / sponsor ID
- KF 02 323948
- Conditions
- Cerebral Palsy
- Keywords
- Motor control, Spasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Oct 2007
- Study completion
- Jul 2009 (actual)
- First posted
- 2 Nov 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.
It is the primary purpose of this pilot study to investigate if physical therapy with strength training is better at improving muscle and gait function after anti-spastic treatment with Botulinum toxin compared to physical therapy without strength training in children with cerebral palsy. The investigators hypothesize that it is.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Other: Physical therapy with strength trainingPhysical therapy with strength training. |
| B | Active comparator | Other: Physical therapy without strength trainingPhysical therapy without strength training. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- cerebral palsy (diplegia and hemiplegia)
- indication for anti-spastic treatment with Botulinum toxin
Key exclusion criteria (1 listed)
- fixed contractures
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 |
|---|---|---|
| Physical therapy with strength training12 weeks of physical therapy after Botulinum-toxin treatment (two 45-min sessions/week) with an emphasis on strength training. | Other | A |
| Physical therapy without strength training12 weeks of physical therapy after Botulinum-toxin treatment (two 45-min sessions/week) without strength training. | Other | B |
Primary outcome
Three-dimensional gait analysis
Time frame: 12 weeks
Selective motor control
Time frame: 12 weeks
2 secondary outcomes
Spasticity (modified Ashworth)
Time frame: 12 weeks
Range of motion
Time frame: 12 weeks
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 7 Sep 2009.
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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.
Thomas Bandholm, MSc principal investigator
Gait Analysis Laboratory, Department of Orthopedic Surgery, Hvidovre University Hospital
Stig Sonne-Holm, MD, DSc study chair
Gait Analysis Laboratory, Department of Orthopedic Surgery, Hvidovre University Hospital
Bente R Jensen, PhD study chair
Institute of Exercise and Sport Sciences, University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical therapy with strength training and Physical therapy without strength training in people with Cerebral Palsy, run by Hvidovre University Hospital at 1 site in Denmark.
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 7 Sep 2009. 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 Denmark. 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.
What does the primary outcome measure?
Three-dimensional gait analysis (time frame: 12 weeks). 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 7 Sep 2009.