Cerebral PalsyNCT00281359
A Comparative Study of the Effectiveness of Treatment of Contractures With Mechanically Applied Stretch and Heat.
A study testing With heat and No heat in people with Cerebral Palsy, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust at 1 site in United Kingdom.
Trial summary
This study is looking at new ways to stretch knee contractures in children with cerebral palsy using a specially designed splint. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- With heat and No heat
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2003to Sep 2006
- 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 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children with cerebral palsy -
Who cannot join
- absent thermal sensation -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust
Oswestry, Shropshire, SY10 7AG
About this study
This study is looking at new ways to stretch knee contractures in children with cerebral palsy using a specially designed splint.
Read the detailed description
When using active orthoses to treat contractures, is the effectiveness of treatment improved by heating the contracted tissue prior to treatment?
- Conditions
- Cerebral Palsy
- Being tested
- With heat, No heat
- Keywords
- cerebral palsy, dynamic splinting, contractures, heat therapy
- Medical subject headings
- Cerebral Palsy, Contracture, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
With heatDevice
Also called heat pad followed by dynamic splinting
heat pad followed by dynamic splinting
No heatDevice
No heat added to tissue prior to dynamic splinting
| Study group | Role | What they receive |
|---|---|---|
| With heat | Experimental | heat applied to contracted tissues prior to using the active stretching orthosis. Receives: Device: With heat |
| Without heat | Placebo comparator | No heat applied to the contracted tissues prior to using the stretching orthosis Receives: Device: No heat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion
15 degree change in RoM
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 posted24 Jan 2006 (estimated)
- Study startApr 2003
- Primary completionSep 2006
- Study completionSep 2006
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
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
- Sponsor type
- Other government
- Collaborators
- Action Medical Research
- Responsible party
- Sponsor
- Investigators
- John Patrick, Principal investigator, Robert Jones and Agnes Hunt Orthopaedic Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00281359
- Sponsor's protocol ID
- RL1 230
- Status last verified
- Nov 2014
- First submitted
- 23 Jan 2006
- Last updated
- 5 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of the Effectiveness of Treatment of Contractures With Mechanically Applied Stretch and Heat.
- ClinicalTrials.gov ID
- NCT00281359
- Acronym / sponsor ID
- RL1 230
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, dynamic splinting, contractures, heat therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS TrustOther government
- Collaborators
- Action Medical Research
- Study start
- Apr 2003
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 24 Jan 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.
This study is looking at new ways to stretch knee contractures in children with cerebral palsy using a specially designed splint.
Detailed description
When using active orthoses to treat contractures, is the effectiveness of treatment improved by heating the contracted tissue prior to treatment?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With heat | Experimental | Device: With heatheat applied to contracted tissues prior to using the active stretching orthosis. |
| Without heat | Placebo comparator | Device: No heatNo heat applied to the contracted tissues prior to using the stretching orthosis |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children with cerebral palsy -
Key exclusion criteria (1 listed)
- absent thermal sensation -
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 |
|---|---|---|
| With heatAlso: heat pad followed by dynamic splintingheat pad followed by dynamic splinting | Device | With heat |
| No heatNo heat added to tissue prior to dynamic splinting | Device | Without heat |
Primary outcome
Range of motion
Time frame: 12 weeks
15 degree change in RoM
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 5 Nov 2014.
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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.
John Patrick principal investigator
Robert Jones and Agnes Hunt Orthopaedic 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 With heat and No heat in people with Cerebral Palsy, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust at 1 site in United Kingdom.
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 1 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 5 Nov 2014. 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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?
Range of motion (time frame: 12 weeks). 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 5 Nov 2014.