Cerebral PalsyNIGHTSTRETCHNCT03686644
Ankle-foot Orthoses for Night Splinting in Children With CP: Impact on Passive Stiffness in Plantarflexors Muscles
A study testing Wearing of night splint ankle foot orthoses (phase A) and No wearing of night splint ankle foot orthoses (phase B) in people with Cerebral Palsy, run by Centre Hospitalier Universitaire de Saint Etienne.
Trial summary
Children with cerebral palsy present early in the childhood altered muscular properties, characterized by short muscle belly length and increased stiffness which contribute to contracture and limiting joint range of motion. 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?
- Wearing of night splint ankle foot orthoses (phase A) and No wearing of night splint ankle foot orthoses (phase B)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 16 Oct 2018to 16 Oct 2018
- 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 diagnosed spastic cerebral palsy
- Children wearing night splint ankle foot orthoses all night long during 1 week minimum
- Children with a level of spasticity in the gastrocnemius muscle greater than or equal to X1, VII, on the Tardieu scale and 2 on the Ashworth scale.
- Children able to understand and respect the simple instructions of the study
- Children and parents who received informed information about the study and who co-signed, with the investigator, a consent to participate in the study.
Who cannot join
- Children who do not tolerate ankle foot orthoses all night long.
- Children who had botulinum injection in gastrocnemius or soleus muscles during last three months.
- Children benefiting from an injection of botulinum toxin or the setting up of new equipment during the protocol.
- Children who do not tolerate ankle foot orthoses all night long.
- Children having benefited from plaster lengthening for less than three months.
About this study
Official title: Effects of Wearing Orthoses on Nightly Postures on Passive Stiffness in Plantar Flexors Muscles in Children With Cerebral Palsy
Children with cerebral palsy present early in the childhood altered muscular properties, characterized by short muscle belly length and increased stiffness which contribute to contracture and limiting joint range of motion. In order to prevent equinus deformity, ankle foot orthoses for night splinting are usually used in children with spastic Cerebral Palsy (CP). However, there's a lack of proof about efficacy by using this modality of treatment. Moreover, impact on quality of life for children and families, cost for society were high.
Principal purpose of this study was to assess impact of night splint ankle foot orthoses on passive stiffness in plantarflexors muscles in children with CP.
Read the detailed description
Children with cerebral palsy present early in the childhood altered muscular properties, characterized by short muscle belly length and increased stiffness which contribute to contracture and limiting joint range of motion. In order to prevent equinus deformity, ankle foot orthoses for night splinting are usually used in children with spastic CP. However, there's a lack of proof about efficacy by using this modality of treatment. Moreover, impact on quality of life for children and families, cost for society were high.
- Conditions
- Cerebral Palsy
- Being tested
- Wearing of night splint ankle foot orthoses (phase A), No wearing of night splint ankle foot orthoses (phase B)
- Keywords
- night splinting, stiffness, ankle foot orthoses, teenager
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearing of night splint ankle foot orthoses (phase A)Procedure or surgery
Children wearing of night splint ankle foot orthoses during 6, 7 or 8 days according to the position of inclusion.
An ultrasound of the leg muscles will be realized every morning after removing night splint.
An isokinetic dynamometer will be realize at the beginning of the study and at the end of each phase.
measure of quality of night sleeping will be measured by Visual Analog Scale (VAS) results.
No wearing of night splint ankle foot orthoses (phase B)Procedure or surgery
Children no wearing of night splint ankle foot orthoses during 6, 7 or 8 days according to the position of inclusion.
An ultrasound of the leg muscles will be realized every morning after removing night splint.
An isokinetic dynamometer will be realize at the beginning of the study and at the end of each phase.
measure of quality of night sleeping will be measured by Visual Analog Scale (VAS) results.
| Study group | Role | What they receive |
|---|---|---|
| Children with Cerebral Palsy | Experimental | Children with Cerebral Palsy (CP) will be included. They will have to wearing of night splint ankle foot orthoses (phase A) and then no wearing of night splint ankle foot orthoses (phase B). The phases A and B will be repeated twice. In more, they will have an ultrasound, isokinetic dynamometer and measure of quality of night sleeping. Receives: Procedure: Wearing of night splint ankle foot orthoses (phase A); Procedure: No wearing of night splint ankle foot orthoses (phase B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline elasticity modulus of the leg muscles at 4 weeks
measured by ultrasounds
Measured: Weeks 0, 1, 2, 3 and 4
Secondary outcomes (4)
Maximal dorsiflexion angle
Measured by isokinetic dynamometer.
Measured: Weeks 0, 1, 2, 3 and 4
Maximum angle of tense knee dorsiflexion
Measured by isokinetic dynamometer.
Measured: Weeks 0, 1, 2, 3 and 4
Torque of force maximal tolerated in maximum angle of tense knee dorsiflexion
Measured by isokinetic dynamometer.
Measured: Weeks 0, 1, 2, 3 and 4
Visual Analog Scale of sleeping
Measured the quality of night sleeping between 0 (bad sleeping) and 10 (good sleeping).
Measured: Weeks 0, 1, 2, 3 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start16 Oct 2018
- Primary completion16 Oct 2018
- Study completion16 Oct 2018
Why it stopped: never started
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 Centre Hospitalier Universitaire de Saint EtienneThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent GAUTHERON, MD PhD, Principal investigator, CHU de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03686644
- Sponsor's protocol ID
- 18CH070
- Other IDs
- 2018-A01082-53
- Acronym
- NIGHTSTRETCH
- Status last verified
- Jul 2022
- First submitted
- 24 Sep 2018
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Wearing Orthoses on Nightly Postures on Passive Stiffness in Plantar Flexors Muscles in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03686644
- Acronym / sponsor ID
- NIGHTSTRETCH / 18CH070
- Conditions
- Cerebral Palsy
- Keywords
- night splinting, stiffness, ankle foot orthoses, teenager
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 16 Oct 2018 (actual)
- Study completion
- 16 Oct 2018 (actual)
- First posted
- 27 Sep 2018 (actual)
- 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.
Children with cerebral palsy present early in the childhood altered muscular properties, characterized by short muscle belly length and increased stiffness which contribute to contracture and limiting joint range of motion. In order to prevent equinus deformity, ankle foot orthoses for night splinting are usually used in children with spastic Cerebral Palsy (CP). However, there's a lack of proof about efficacy by using this modality of treatment. Moreover, impact on quality of life for children and families, cost for society were high.
Principal purpose of this study was to assess impact of night splint ankle foot orthoses on passive stiffness in plantarflexors muscles in children with CP.
Detailed description
Children with cerebral palsy present early in the childhood altered muscular properties, characterized by short muscle belly length and increased stiffness which contribute to contracture and limiting joint range of motion. In order to prevent equinus deformity, ankle foot orthoses for night splinting are usually used in children with spastic CP. However, there's a lack of proof about efficacy by using this modality of treatment. Moreover, impact on quality of life for children and families, cost for society were high.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with Cerebral Palsy | Experimental | Procedure: Wearing of night splint ankle foot orthoses (phase A), Procedure: No wearing of night splint ankle foot orthoses (phase B)Children with Cerebral Palsy (CP) will be included. They will have to wearing of night splint ankle foot orthoses (phase A) and then no wearing of night splint ankle foot orthoses (phase B). The phases A and B will be repeated twice. In more, they will have an ultrasound, isokinetic dynamometer and measure of quality of night sleeping. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children diagnosed spastic cerebral palsy
- Children wearing night splint ankle foot orthoses all night long during 1 week minimum
- Children with a level of spasticity in the gastrocnemius muscle greater than or equal to X1, VII, on the Tardieu scale and 2 on the Ashworth scale.
- Children able to understand and respect the simple instructions of the study
- Children and parents who received informed information about the study and who co-signed, with the investigator, a consent to participate in the study.
Key exclusion criteria (5 listed)
- Children who do not tolerate ankle foot orthoses all night long.
- Children who had botulinum injection in gastrocnemius or soleus muscles during last three months.
- Children benefiting from an injection of botulinum toxin or the setting up of new equipment during the protocol.
- Children who do not tolerate ankle foot orthoses all night long.
- Children having benefited from plaster lengthening for less than three months.
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 |
|---|---|---|
| Wearing of night splint ankle foot orthoses (phase A)Children wearing of night splint ankle foot orthoses during 6, 7 or 8 days according to the position of inclusion. An ultrasound of the leg muscles will be realized every morning after removing night splint. An isokinetic dynamometer will be realize at the beginning of the study and at the end of each phase. measure of quality of night sleeping will be measured by Visual Analog Scale (VAS) results. | Procedure or surgery | Children with Cerebral Palsy |
| No wearing of night splint ankle foot orthoses (phase B)Children no wearing of night splint ankle foot orthoses during 6, 7 or 8 days according to the position of inclusion. An ultrasound of the leg muscles will be realized every morning after removing night splint. An isokinetic dynamometer will be realize at the beginning of the study and at the end of each phase. measure of quality of night sleeping will be measured by Visual Analog Scale (VAS) results. | Procedure or surgery | Children with Cerebral Palsy |
Primary outcome
change from baseline elasticity modulus of the leg muscles at 4 weeks
Time frame: Weeks 0, 1, 2, 3 and 4
measured by ultrasounds
4 secondary outcomes
Maximal dorsiflexion angle
Time frame: Weeks 0, 1, 2, 3 and 4
Maximum angle of tense knee dorsiflexion
Time frame: Weeks 0, 1, 2, 3 and 4
Torque of force maximal tolerated in maximum angle of tense knee dorsiflexion
Time frame: Weeks 0, 1, 2, 3 and 4
Visual Analog Scale of sleeping
Time frame: Weeks 0, 1, 2, 3 and 4
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Vincent GAUTHERON, MD PhD principal investigator
CHU de Saint Etienne
Questions about this trial
What is this clinical trial studying?
A study testing Wearing of night splint ankle foot orthoses (phase A) and No wearing of night splint ankle foot orthoses (phase B) in people with Cerebral Palsy, run by Centre Hospitalier Universitaire de Saint Etienne.
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 5 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: withdrawn, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
change from baseline elasticity modulus of the leg muscles at 4 weeks (time frame: Weeks 0, 1, 2, 3 and 4). 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 22 Jul 2022.