Brain DamageNCT01076257
Efficacy of Modified Constraint-induced Movement Therapy in Children With Brain Damage
A study testing Modified Constraint-induced Movement Therapy in people with Brain Damage and Cerebral Palsy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This research centers on the comparison of the immediate efficacy (right after therapy) and the maintained efficacy (3 months and 6 months) between "Modified Constraint-Induced Movement Therapy" (mCIMT) group and control group at different age. Read more about this study
- Who is it for?
- Ages 4 to 15 years
- Conditions the study is for
- Brain Damage, Cerebral Palsy, Traumatic Brain Damage
- What is being tested?
- Modified Constraint-induced Movement Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2009to Jul 2010
- 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 4 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Development learned-nonuse
- Age range 4y/o-15y/o
- Wrist ext 10˚, MP j't ext 10˚ in affected U/E
- Can fallow up the simple instruction
- Modified Ashworth Scale ≦2
- Pediatric Motor Activity Log ≦2.5 (average)
Who cannot join
- Related muscle skeleton surgery
- Selective dorsal rhizotomy
- Botulinum toxin in 6 months
- Visual perception impaired
- Hearing perception impaired
- Balance ability impaired (in constrained)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Modified Constraint-induced Movement Therapy in Children With Brain Damage: Evidence of Kinematic Study
This research centers on the comparison of the immediate efficacy (right after therapy) and the maintained efficacy (3 months and 6 months) between "Modified Constraint-Induced Movement Therapy" (mCIMT) group and control group at different age.
Read the detailed description
"Modified Constraint-Induced Movement Therapy" is one of the most recent treatments for children with Brain damage.
This well-designed and follow-up RCT study compared home-based CIT with a control intervention (traditional rehabilitation, TR) by combining kinematic analysis and clinical evaluation, which is possible to examine whether functional improvement is accompanied by a change in motor control. We hypothesized that home-based CIT would induce better motor control strategies (shorter RT, MT, lesser MUs, MGA, and PMGA, and larger peak velocity (PV)) for greater functional gains than TR. Furthermore, the beneficial effects would be maintained at 3 and 6 months of follow-up. Findings of this study allow clinicians to understand the underlying motor control changes for functional improvement after home-based CIT.
- Conditions
- Brain Damage, Cerebral Palsy, Traumatic Brain Damage
- Being tested
- Modified Constraint-induced Movement Therapy
- Keywords
- brain damage, constraint induced movement therapy, kinematic, function, outcome, Quality of life
- Medical subject headings
- Brain Injuries, Cerebral Palsy, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Constraint-induced Movement TherapyBehavioural
Also called Constraint-Induced Therapy, Forced-use Therapy, Immobilization Therapy
Home based CIT
- Restriction of the less affected limb
- Intensive practice using affected limb
- Positive experience
- Functional task (task)
| Study group | Role | What they receive |
|---|---|---|
| Constraint-induced Movement Therapy | Experimental | Not described Receives: Behavioral: Modified Constraint-induced Movement Therapy |
| Transditional rehabilitation | Other | Not described Receives: Behavioral: Modified Constraint-induced Movement Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bruininks-Oseretsky Test of Motor Proficiency (BOTMP)
All children underwent a series of upper limb assessments, including kinematic analysis and functional measures (primary and secondary outcomes), before the start of the intervention (pretreatment). An occupational therapist blinded to group assignment was trained to administer these measures. All participants underwent these assessments at 4 weeks immediately after intervention (post-treatment), and at 12-week follow-up and 24-week follow-up.
Measured: 4 weeks (post-treatment), 12 week, 24 week
Peabody Development Motor Scales, subtest fine motor (PDMS-Ⅱ)
Measured: 4 weeks (post-treatment), 12 week, 24 week
Kinematic analysis
Measured: 4 weeks (post-treatment), 12 week, 24 week
Secondary outcomes (3)
Pediatric Motor Activity Log ( PMAL )
All children underwent a series of upper limb assessments, including kinematic analysis and functional measures (primary and secondary outcomes), before the start of the intervention (pretreatment). An occupational therapist blinded to group assignment was trained to administer these measures. All participants underwent these assessments at 4 weeks immediately after intervention (post-treatment), and at 12-week follow-up and 24-week follow-up.
Measured: 4 weeks (post-treatment), 12 week, 24 week
Pediatric Functional Independence Measure ( WeeFIM )
Measured: 4 weeks (post-treatment), 12 week, 24 week
Cerebral palsy quality of life (CPQoL)
Measured: 4 weeks (post-treatment), 12 week, 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2010 (estimated)
- Study startJun 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain DamageStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chia-Ling chen, MD,PhD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01076257
- Sponsor's protocol ID
- 97-1823B
- Status last verified
- May 2010
- First submitted
- 4 Jan 2010
- Last updated
- 31 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Modified Constraint-induced Movement Therapy in Children With Brain Damage: Evidence of Kinematic Study
- ClinicalTrials.gov ID
- NCT01076257
- Acronym / sponsor ID
- 97-1823B
- Conditions
- Brain Damage, Cerebral Palsy, Traumatic Brain Damage
- Keywords
- brain damage, constraint induced movement therapy, kinematic, function, outcome, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 26 Feb 2010 (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 research centers on the comparison of the immediate efficacy (right after therapy) and the maintained efficacy (3 months and 6 months) between "Modified Constraint-Induced Movement Therapy" (mCIMT) group and control group at different age.
Detailed description
"Modified Constraint-Induced Movement Therapy" is one of the most recent treatments for children with Brain damage.
This well-designed and follow-up RCT study compared home-based CIT with a control intervention (traditional rehabilitation, TR) by combining kinematic analysis and clinical evaluation, which is possible to examine whether functional improvement is accompanied by a change in motor control. We hypothesized that home-based CIT would induce better motor control strategies (shorter RT, MT, lesser MUs, MGA, and PMGA, and larger peak velocity (PV)) for greater functional gains than TR. Furthermore, the beneficial effects would be maintained at 3 and 6 months of follow-up. Findings of this study allow clinicians to understand the underlying motor control changes for functional improvement after home-based CIT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Constraint-induced Movement Therapy | Experimental | Behavioral: Modified Constraint-induced Movement Therapy |
| Transditional rehabilitation | Other | Behavioral: Modified Constraint-induced Movement Therapy |
Who may qualify
- Ages
- 4 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Development learned-nonuse
- Age range 4y/o-15y/o
- Wrist ext 10˚, MP j't ext 10˚ in affected U/E
- Can fallow up the simple instruction
- Modified Ashworth Scale ≦2
Key exclusion criteria (6 listed)
- Related muscle skeleton surgery
- Selective dorsal rhizotomy
- Botulinum toxin in 6 months
- Visual perception impaired
- Hearing perception impaired
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 |
|---|---|---|
| Modified Constraint-induced Movement TherapyAlso: Constraint-Induced Therapy, Forced-use Therapy, Immobilization TherapyHome based CIT 1. Restriction of the less affected limb 2. Intensive practice using affected limb 3. Positive experience 4. Functional task (task) | Behavioural | Constraint-induced Movement Therapy, Transditional rehabilitation |
Primary outcome
Bruininks-Oseretsky Test of Motor Proficiency (BOTMP)
Time frame: 4 weeks (post-treatment), 12 week, 24 week
All children underwent a series of upper limb assessments, including kinematic analysis and functional measures (primary and secondary outcomes), before the start of the intervention (pretreatment). An occupational therapist blinded to group assignment was trained to administer these measures. All participants underwent these assessments at 4 weeks immediately after intervention (post-treatment), and at 12-week follow-up and 24-week follow-up.
Peabody Development Motor Scales, subtest fine motor (PDMS-Ⅱ)
Time frame: 4 weeks (post-treatment), 12 week, 24 week
Kinematic analysis
Time frame: 4 weeks (post-treatment), 12 week, 24 week
3 secondary outcomes
Pediatric Motor Activity Log ( PMAL )
Time frame: 4 weeks (post-treatment), 12 week, 24 week
Pediatric Functional Independence Measure ( WeeFIM )
Time frame: 4 weeks (post-treatment), 12 week, 24 week
Cerebral palsy quality of life (CPQoL)
Time frame: 4 weeks (post-treatment), 12 week, 24 week
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 31 Jul 2012.
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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.
Chia-Ling chen, MD,PhD principal investigator
Chang Gung Memorial 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 Modified Constraint-induced Movement Therapy in people with Brain Damage and Cerebral Palsy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 6 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 31 Jul 2012. 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 Taiwan. 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?
Bruininks-Oseretsky Test of Motor Proficiency (BOTMP) (time frame: 4 weeks (post-treatment), 12 week, 24 week). The study lists 3 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 31 Jul 2012.