Cerebral PalsyPhase 3NCT03306212
Efficacy of Intermittent Serial Casting on Spastic Wrist Flexion Deformity
A Phase 3 study testing Botulinum toxin A, Occupational Therapy and Intermittent serial casting in people with Cerebral Palsy, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
Spastic wrist flexion deformity is a very common problem in children with CP. Although serial casting (SC) is one of the commonly used interventions in addition to botulinum toxin A (BoNT-A) injections and physical therapy for spastic deformities of lower extremity of children with CP, there is limited data on SC in… Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Botulinum toxin A, Occupational Therapy and Intermittent serial casting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2014to 1 Dec 2017
- Phase
- Phase 3
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- having a diagnosis of CP according to Rosenbaum criteria,
- having a unilateral spastic palmar flexion deformity of wrist joint,
- having a Modified Ashworth Scale (MAS) score of 3 in the palmar flexor muscle complex,
- being scheduled for BoNT-A treatment to upper extremity including palmar flexor muscle group.
Who cannot join
- having cognitive dysfunction,
- having a history of orthopedic surgery to upper extremity,
- having significant dystonia,
- having infection skin breakdown,
- having vascular disease,
- having fracture or dislocation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Intermittent Serial Casting on Spastic Wrist Flexion Deformity in Children With Cerebral Palsy Treated By Botulinum Toxin A
Spastic wrist flexion deformity is a very common problem in children with CP. Although serial casting (SC) is one of the commonly used interventions in addition to botulinum toxin A (BoNT-A) injections and physical therapy for spastic deformities of lower extremity of children with CP, there is limited data on SC in the upper extremity.
In this prospective, randomized, controlled clinical trial in order to overcome the issues with patient compliance, side effects and combined treatment options an intermittent SC model was developed. The objective of this study was to show the effects of intermittent SC when combined with occupational therapy (OT) and BoNT-A injections on spasticity, and passive range of motion (pROM) of children with CP having spastic wrist flexion deformity.
Read the detailed description
Spasticity is not only the most common motor disorder but also the main cause of slowly developing secondary problems like contractures in children with cerebral palsy (CP). Spastic wrist flexion deformity is a very common problem in children with CP and can be primarily due to spasticity of the palmar muscle complex, can be exacerbated by the weakness of the antagonist dorsiflexor muscles and can involve soft tissue and joint contractures. Although serial casting (SC) is one of the commonly used interventions in addition to botulinum toxin A (BoNT-A) injections and physical therapy for spastic deformities of lower extremity of children with CP, there is limited data on SC in the upper extremity. Skin irritation or breakdown, painful epizodes, oedema, tendonitis, weakness, stiffness are some of the side effects reported after SC. Moreover casting especially when prolonged might complicate activities of daily living for instance by increasing the risk of falls or causing problems in bathing. Recent evidence from literature favors early, goal oriented, activity based, intensive, repetitive motor trainings in enriched environments to optimize neuroplasticity in children with CP. Prolonged serial casting might also interfere with these activity based, intensive rehabilitation options for upper extremity.
In this prospective, randomized, controlled clinical trial in order to overcome the issues with patient compliance, side effects and combined treatment options an intermittent SC model was developed. The objective of this study was to show the effects of intermittent SC when combined with occupational therapy (OT) and BoNT-A injections on spasticity, and passive range of motion (pROM) of children with CP having spastic wrist flexion deformity.
- Conditions
- Cerebral Palsy
- Being tested
- Botulinum toxin A, Occupational Therapy, Intermittent serial casting
- Keywords
- cerebral palsy, casting, Botulinum toxin A
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin ADrug
Also called Dysport
Occupational TherapyOther
Intermittent serial castingOther
| Study group | Role | What they receive |
|---|---|---|
| Casting Group | Experimental | Patients treated by botulinum toxin A and occupational therapy and intermittent serial casting Receives: Drug: Botulinum toxin A; Other: Occupational Therapy; Other: Intermittent serial casting |
| Control Group | Active comparator | Patients treated by botulinum toxin A and occupational therapy Receives: Drug: Botulinum toxin A; Other: Occupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline Passive ROM
Range of motion measurement
Measured: 12 weeks
Mean change from baseline MAS score
Tone measurement
Measured: 12 weeks
Secondary outcomes (1)
Mean change from XV3 angle of Tardieu scale
Spasticity measurement
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 posted10 Oct 2017
- Study start1 Nov 2014
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nigar Dursun, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306212
- Sponsor's protocol ID
- KOU KAEK 2014/269
- Status last verified
- Mar 2018
- First submitted
- 5 Oct 2017
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Intermittent Serial Casting on Spastic Wrist Flexion Deformity in Children With Cerebral Palsy Treated By Botulinum Toxin A
- ClinicalTrials.gov ID
- NCT03306212
- Acronym / sponsor ID
- KOU KAEK 2014/269
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, casting, Botulinum toxin A
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 10 Oct 2017 (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.
Spastic wrist flexion deformity is a very common problem in children with CP. Although serial casting (SC) is one of the commonly used interventions in addition to botulinum toxin A (BoNT-A) injections and physical therapy for spastic deformities of lower extremity of children with CP, there is limited data on SC in the upper extremity.
In this prospective, randomized, controlled clinical trial in order to overcome the issues with patient compliance, side effects and combined treatment options an intermittent SC model was developed. The objective of this study was to show the effects of intermittent SC when combined with occupational therapy (OT) and BoNT-A injections on spasticity, and passive range of motion (pROM) of children with CP having spastic wrist flexion deformity.
Detailed description
Spasticity is not only the most common motor disorder but also the main cause of slowly developing secondary problems like contractures in children with cerebral palsy (CP). Spastic wrist flexion deformity is a very common problem in children with CP and can be primarily due to spasticity of the palmar muscle complex, can be exacerbated by the weakness of the antagonist dorsiflexor muscles and can involve soft tissue and joint contractures. Although serial casting (SC) is one of the commonly used interventions in addition to botulinum toxin A (BoNT-A) injections and physical therapy for spastic deformities of lower extremity of children with CP, there is limited data on SC in the upper extremity. Skin irritation or breakdown, painful epizodes, oedema, tendonitis, weakness, stiffness are some of the side effects reported after SC. Moreover casting especially when prolonged might complicate activities of daily living for instance by increasing the risk of falls or causing problems in bathing. Recent evidence from literature favors early, goal oriented, activity based, intensive, repetitive motor trainings in enriched environments to optimize neuroplasticity in children with CP. Prolonged serial casting might also interfere with these activity based, intensive rehabilitation options for upper extremity.
In this prospective, randomized, controlled clinical trial in order to overcome the issues with patient compliance, side effects and combined treatment options an intermittent SC model was developed. The objective of this study was to show the effects of intermittent SC when combined with occupational therapy (OT) and BoNT-A injections on spasticity, and passive range of motion (pROM) of children with CP having spastic wrist flexion deformity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Casting Group | Experimental | Drug: Botulinum toxin A, Other: Occupational Therapy, Other: Intermittent serial castingPatients treated by botulinum toxin A and occupational therapy and intermittent serial casting |
| Control Group | Active comparator | Drug: Botulinum toxin A, Other: Occupational TherapyPatients treated by botulinum toxin A and occupational therapy |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- having a diagnosis of CP according to Rosenbaum criteria,
- having a unilateral spastic palmar flexion deformity of wrist joint,
- having a Modified Ashworth Scale (MAS) score of 3 in the palmar flexor muscle complex,
- being scheduled for BoNT-A treatment to upper extremity including palmar flexor muscle group.
Key exclusion criteria (6 listed)
- having cognitive dysfunction,
- having a history of orthopedic surgery to upper extremity,
- having significant dystonia,
- having infection skin breakdown,
- having vascular disease,
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 |
|---|---|---|
| Botulinum toxin AAlso: Dysport | Drug | Casting Group, Control Group |
| Occupational Therapy | Other | Casting Group, Control Group |
| Intermittent serial casting | Other | Casting Group |
Primary outcome
Mean change from baseline Passive ROM
Time frame: 12 weeks
Range of motion measurement
Mean change from baseline MAS score
Time frame: 12 weeks
Tone measurement
1 secondary outcome
Mean change from XV3 angle of Tardieu scale
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 27 Mar 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botulinum toxin A, Occupational Therapy and Intermittent serial casting in people with Cerebral Palsy, run by Kocaeli University at 1 site in Turkey (Türkiye).
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 4 inclusion and 6 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 27 Mar 2018. 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 Turkey (Türkiye). 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Mean change from baseline Passive ROM (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 27 Mar 2018.