Cerebral Palsy, SpasticNCT04179682
A Pilot Study of Constraint Induced Movement Therapy in Preschool Cerebral Palsy After Botulism Toxin Injection
A study testing 40-hour constraint-induced movement therapy in people with Cerebral Palsy, Spastic and Rehabilitation, run by Changhua Christian Hospital.
Trial summary
To establish a pilot randomized, crossover study on applying 2 constraint-induced movement therapy (CIMT) interventions in children with hemiplegic cerebral palsy after botulinum toxin injection during preschool education. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Cerebral Palsy, Spastic, Rehabilitation
- What is being tested?
- 40-hour constraint-induced movement therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2014to 1 Oct 2019
- 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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- hemiplegic or quadriplegic CP children were under a regular rehabilitation program with BoNT-A injections. They were classified as Gross Motor Function Classification System level I and II, aged between 3 and 6 years old, with at least below average mentality, and were in mainstream preschool education; the extension of their hemiplegic wrist and metaphalangeal joint was greater than 10 degrees.
Who cannot join
- Children were excluded if they (a) could not understand or cooperate with the CIMT program, (b) had joint contracture of an upper limb, and (c) could not actively extend their hemiplegic wrist.
About this study
Official title: The Pilot Study of Constraint Induced Movement Therapy(CIMT） Intervention in Children With Hemiplegic Cerebral Palsy After Botulism Toxin Injection in Preschool Education
To establish a pilot randomized, crossover study on applying 2 constraint-induced movement therapy (CIMT) interventions in children with hemiplegic cerebral palsy after botulinum toxin injection during preschool education.
Read the detailed description
This study was designed to be a pilot study on the use of 4-week 2-hours/day and 2-week 4-hours/day CIMT interventions in children with hemiplegic CP after a BoNT-A injection in preschool education, and compared the effects and psychological stress of CP children relative to the 2 CIMT programs.
- Conditions
- Cerebral Palsy, Spastic, Rehabilitation
- Being tested
- 40-hour constraint-induced movement therapy
- Keywords
- cerebral palsy, constraint-induced movement therapy, botulinum toxin, rehabilitation, occupational therapy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
40-hour constraint-induced movement therapyProcedure or surgery
Participants were randomly allocated to 1 of 2 CIMT programs (40 hours): a 2-week 4-hours/day CIMT program and a 4-week 2-hours/day CIMT program. One CIMT program was performed 1 month after a BoNT-A injection, and then the second program was implemented with the next injection.
| Study group | Role | What they receive |
|---|---|---|
| 4-week 2-hours/day CIMT program | Active comparator | a 4-week 2-hours/day constraint program, total 40 hours CIMT, in preschool education. Receives: Procedure: 40-hour constraint-induced movement therapy |
| 2-week 4-hours/day CIMT program | Active comparator | one was a 2-week 4-hours/day constraint program, total 40 hours CIMT, in preschool education. Receives: Procedure: 40-hour constraint-induced movement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of Modified Ashworth Scale(MAS)
change of spasticity, from 0 to 4, higher scores mean a worse outcome.
Measured: 1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT, and 4 months after CIMT
change of Visual-motor integration in Peabody-Developmental Motor Scales(PDMSⅡ)
hand function, from 0 to 144, higher scores mean a better outcome.
Measured: 1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT, and 4 months after CIMT
Change of grasping in Peabody-Developmental Motor Scales(PDMSⅡ)
hand function. from 0 to 52, higher scores mean a better outcome.
Measured: 1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT, and 4 months after CIMT
Change of Chinese Version of Pediatric Evaluation of Disability Inventory( PEDI-C)
ADL, from 0 to 73, higher scores mean a better outcome.
Measured: 1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT and 4 months after CIMT
Change of GAS(goal attainment scale)
GAS included 2 playing goals and 2 self-care goals.The goals were decided by the occupation therapist, the preschool teacher and the major caregiver. From (-2) to 2, higher scores mean a better outcome.
Measured: 1 month after Botox injection, 2 months after CIMT and 4 months after CIMT
Change of Caregiver-Teacher Report Form (C-TRF)-Diagnostic scale of the Achenbach System of Empirically-Based Assessment (ASEBA)
From 0 to 14, higher scores mean a worse outcome.
Measured: 1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT and 4 months after CIMT
Change of Statistical Manual (DSM)-oriented scale of the Achenbach System of Empirically-Based Assessment (ASEBA)
From 0 to 14, higher scores mean a worse outcome.
Measured: 1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT and 4 months after CIMT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start1 Jul 2014
- Primary completion10 Feb 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy, SpasticStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04179682
- Sponsor's protocol ID
- 130210
- Status last verified
- Nov 2019
- First submitted
- 21 Nov 2019
- Last updated
- 27 Nov 2019
- 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 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pilot Study of Constraint Induced Movement Therapy(CIMT） Intervention in Children With Hemiplegic Cerebral Palsy After Botulism Toxin Injection in Preschool Education
- ClinicalTrials.gov ID
- NCT04179682
- Acronym / sponsor ID
- 130210
- Conditions
- Cerebral Palsy, Spastic, Rehabilitation
- Keywords
- cerebral palsy, constraint-induced movement therapy, botulinum toxin, rehabilitation, occupational therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- 1 Jul 2014 (actual)
- Primary completion
- 10 Feb 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 27 Nov 2019 (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.
To establish a pilot randomized, crossover study on applying 2 constraint-induced movement therapy (CIMT) interventions in children with hemiplegic cerebral palsy after botulinum toxin injection during preschool education.
Detailed description
This study was designed to be a pilot study on the use of 4-week 2-hours/day and 2-week 4-hours/day CIMT interventions in children with hemiplegic CP after a BoNT-A injection in preschool education, and compared the effects and psychological stress of CP children relative to the 2 CIMT programs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4-week 2-hours/day CIMT program | Active comparator | Procedure: 40-hour constraint-induced movement therapya 4-week 2-hours/day constraint program, total 40 hours CIMT, in preschool education. |
| 2-week 4-hours/day CIMT program | Active comparator | Procedure: 40-hour constraint-induced movement therapyone was a 2-week 4-hours/day constraint program, total 40 hours CIMT, in preschool education. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- hemiplegic or quadriplegic CP children were under a regular rehabilitation program with BoNT-A injections. They were classified as Gross Motor Function Classification System level I and II, aged between 3 and 6 years old, with at least below average mentality, and were in mainstream preschool education; the extension of their hemiplegic wrist and metaphalangeal joint was greater than 10 degrees.
Key exclusion criteria (1 listed)
- Children were excluded if they (a) could not understand or cooperate with the CIMT program, (b) had joint contracture of an upper limb, and (c) could not actively extend their hemiplegic wrist.
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 |
|---|---|---|
| 40-hour constraint-induced movement therapyParticipants were randomly allocated to 1 of 2 CIMT programs (40 hours): a 2-week 4-hours/day CIMT program and a 4-week 2-hours/day CIMT program. One CIMT program was performed 1 month after a BoNT-A injection, and then the second program was implemented with the next injection. | Procedure or surgery | 2-week 4-hours/day CIMT program, 4-week 2-hours/day CIMT program |
Primary outcome
change of Modified Ashworth Scale(MAS)
Time frame: 1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT, and 4 months after CIMT
change of spasticity, from 0 to 4, higher scores mean a worse outcome.
change of Visual-motor integration in Peabody-Developmental Motor Scales(PDMSⅡ)
Time frame: 1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT, and 4 months after CIMT
hand function, from 0 to 144, higher scores mean a better outcome.
Change of grasping in Peabody-Developmental Motor Scales(PDMSⅡ)
Time frame: 1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT, and 4 months after CIMT
hand function. from 0 to 52, higher scores mean a better outcome.
Change of Chinese Version of Pediatric Evaluation of Disability Inventory( PEDI-C)
Time frame: 1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT and 4 months after CIMT
ADL, from 0 to 73, higher scores mean a better outcome.
Change of GAS(goal attainment scale)
Time frame: 1 month after Botox injection, 2 months after CIMT and 4 months after CIMT
GAS included 2 playing goals and 2 self-care goals.The goals were decided by the occupation therapist, the preschool teacher and the major caregiver. From (-2) to 2, higher scores mean a better outcome.
Change of Caregiver-Teacher Report Form (C-TRF)-Diagnostic scale of the Achenbach System of Empirically-Based Assessment (ASEBA)
Time frame: 1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT and 4 months after CIMT
From 0 to 14, higher scores mean a worse outcome.
Change of Statistical Manual (DSM)-oriented scale of the Achenbach System of Empirically-Based Assessment (ASEBA)
Time frame: 1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT and 4 months after CIMT
From 0 to 14, higher scores mean a worse outcome.
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 Nov 2019.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing 40-hour constraint-induced movement therapy in people with Cerebral Palsy, Spastic and Rehabilitation, run by Changhua Christian Hospital.
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 27 Nov 2019. 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 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?
change of Modified Ashworth Scale(MAS) (time frame: 1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT, and 4 months after CIMT). The study lists 7 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 Nov 2019.