Cerebral PalsyNCT01643239
Effects of Forms of Modified CIT on Upper Extremity Performance in Cerebral Palsy
A study testing Hospital-based mCIT restraint of the unaffected arm and practice of the affected arm, Hospital-based mCIT and Hospital-based TR in people with Cerebral Palsy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study will employ clinical assessment tools to examine the effects of modified constraint-induced therapy (mCIT) on the more affected upper extremity of children with cerebral palsy. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Hospital-based mCIT restraint of the unaffected arm and practice of the affected arm, Hospital-based mCIT and Hospital-based TR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 1996to Sep 2012
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- clinical diagnosis of spastic CP
- age between 4 and 10 years old
- shoulder flexion of the affected upper limb more than 90 degrees, elbow extension over 160 degrees, wrist extension to 10 degrees at least, and fingers full flexion to 10 degrees at least
- basic balance ability: sitting on the chair without arm support; feet stay on the floor consistently; performing the affected upper limb movement without losing balance
- ability to follow simple oral commands
- no related musculoskeletal surgery of the affected upper limb
- not have injected the Botox into the affected upper extremity during the past 6 months
- no visual or auditory disability
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Forms of Modified Constraint-induced Therapy on Functional Performance of Upper Extremity in Children With Cerebral Palsy With Asymmetric Motor Impairments: A Follow up Study of Kinematic and Clinical Analyses
The purpose of this study will employ clinical assessment tools to examine the effects of modified constraint-induced therapy (mCIT) on the more affected upper extremity of children with cerebral palsy.
Read the detailed description
The study included threefold: (1) It will employ kinematic analysis, along with clinical assessment tools to examine the effects of mCIT on the more affected upper extremity of children with cerebral palsy with asymmetric motor impairments after treatment immediately and 1 year following. The clinical tools will include Motor Activity Log (MAL), Bruininks-Oseretsky Test of Motor Proficiency (BOTMP),Peabody-Developmental Motor Scales (PDMS-II), and Wee-FIM. (2) This study looked at the intervention impact on bimanual coordination and the less affected upper extremity. (3) It investigated the effects of forms (group vs. individual intervention) on upper extremity performance.
- Conditions
- Cerebral Palsy
- Being tested
- Hospital-based mCIT restraint of the unaffected arm and practice of the affected arm, Hospital-based mCIT, Hospital-based TR
- Keywords
- Modified constraint-induced therapy, Children with cerebral palsy, Kinematic analysis, Group 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.
Hospital-based mCIT restraint of the unaffected arm and practice of the affected armOther
Also called Hospital-based modified constraint-induced therapy(mCIT)
the mCIT group with individualized intervention
Hospital-based mCITOther
Also called Hospital-based modified constraint-induced therapy(mCIT)
the mCIT group with individualized intervention
Hospital-based TROther
Also called Hospital-based traditional rehabilitation (TR)
OT or PT or therapist-based training
| Study group | Role | What they receive |
|---|---|---|
| Hospital-based mCIT with individualized intervention | Experimental | Hospital-based modified constraint-induced therapy(mCIT) Receives: Other: Hospital-based mCIT restraint of the unaffected arm and practice of the affected arm |
| Hospital-based mCIT with group therapy | Experimental | Hospital-based modified constraint-induced therapy(mCIT) Receives: Other: Hospital-based mCIT |
| Hospital-based TR | Other | Hospital-based traditional rehabilitation (TR) Receives: Other: Hospital-based TR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinematic assessment
An analysis program coded by LabVIEW (National Instruments, Inc., Austin, TX) language was used to process the kinematic data. The variables of reaction time (sec), normalized movement time (sec/mm), normalized total displacement (unit), joint ranges recruitment (normalized shoulder flexion angle, normalized elbow flexion; degree/mm) angle, and normalized maximum shoulder abduction angle), and maximum shoulder and elbow cross correlation were collected.
Measured: up to six years
Secondary outcomes (1)
Clinical measures at the motor quality and performance include Motor Activity Log (MAL), Bruininks-Oseretsky Test of Motor Proficiency (BOTMP), and Peabody-Developmental Motor Scales (PDMS-II)
The clinical tools used in this study measure the intervention impact on bimanual coordination and unilateral performance of upper extremity.
Measured: up to six years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2012 (estimated)
- Study startAug 1996
- Primary completionSep 2012
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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chang Gung University, National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Ching-yi Wu, ScD, Principal investigator, Department of Occupational Therapy, Chang Gung Univ.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01643239
- Sponsor's protocol ID
- 94-1052B
- Status last verified
- Feb 2013
- First submitted
- 4 Jul 2012
- Last updated
- 28 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Forms of Modified Constraint-induced Therapy on Functional Performance of Upper Extremity in Children With Cerebral Palsy With Asymmetric Motor Impairments: A Follow up Study of Kinematic and Clinical Analyses
- ClinicalTrials.gov ID
- NCT01643239
- Acronym / sponsor ID
- 94-1052B
- Conditions
- Cerebral Palsy
- Keywords
- Modified constraint-induced therapy, Children with cerebral palsy, Kinematic analysis, Group therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Chang Gung University, National Science and Technology Council, Taiwan
- Study start
- Aug 1996
- Primary completion
- Sep 2012 (actual)
- First posted
- 18 Jul 2012 (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.
The purpose of this study will employ clinical assessment tools to examine the effects of modified constraint-induced therapy (mCIT) on the more affected upper extremity of children with cerebral palsy.
Detailed description
The study included threefold: (1) It will employ kinematic analysis, along with clinical assessment tools to examine the effects of mCIT on the more affected upper extremity of children with cerebral palsy with asymmetric motor impairments after treatment immediately and 1 year following. The clinical tools will include Motor Activity Log (MAL), Bruininks-Oseretsky Test of Motor Proficiency (BOTMP),Peabody-Developmental Motor Scales (PDMS-II), and Wee-FIM. (2) This study looked at the intervention impact on bimanual coordination and the less affected upper extremity. (3) It investigated the effects of forms (group vs. individual intervention) on upper extremity performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hospital-based mCIT with individualized intervention | Experimental | Other: Hospital-based mCIT restraint of the unaffected arm and practice of the affected armHospital-based modified constraint-induced therapy(mCIT) |
| Hospital-based mCIT with group therapy | Experimental | Other: Hospital-based mCITHospital-based modified constraint-induced therapy(mCIT) |
| Hospital-based TR | Other | Other: Hospital-based TRHospital-based traditional rehabilitation (TR) |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- clinical diagnosis of spastic CP
- age between 4 and 10 years old
- shoulder flexion of the affected upper limb more than 90 degrees, elbow extension over 160 degrees, wrist extension to 10 degrees at least, and fingers full flexion to 10 degrees at least
- basic balance ability: sitting on the chair without arm support; feet stay on the floor consistently; performing the affected upper limb movement without losing balance
- ability to follow simple oral commands
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Hospital-based mCIT restraint of the unaffected arm and practice of the affected armAlso: Hospital-based modified constraint-induced therapy(mCIT)the mCIT group with individualized intervention | Other | Hospital-based mCIT with individualized intervention |
| Hospital-based mCITAlso: Hospital-based modified constraint-induced therapy(mCIT)the mCIT group with individualized intervention | Other | Hospital-based mCIT with group therapy |
| Hospital-based TRAlso: Hospital-based traditional rehabilitation (TR)OT or PT or therapist-based training | Other | Hospital-based TR |
Primary outcome
Kinematic assessment
Time frame: up to six years
An analysis program coded by LabVIEW (National Instruments, Inc., Austin, TX) language was used to process the kinematic data. The variables of reaction time (sec), normalized movement time (sec/mm), normalized total displacement (unit), joint ranges recruitment (normalized shoulder flexion angle, normalized elbow flexion; degree/mm) angle, and normalized maximum shoulder abduction angle), and maximum shoulder and elbow cross correlation were collected.
1 secondary outcome
Clinical measures at the motor quality and performance include Motor Activity Log (MAL), Bruininks-Oseretsky Test of Motor Proficiency (BOTMP), and Peabody-Developmental Motor Scales (PDMS-II)
Time frame: up to six years
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 28 Feb 2013.
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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.
Ching-yi Wu, ScD principal investigator
Department of Occupational Therapy, Chang Gung Univ.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hospital-based mCIT restraint of the unaffected arm and practice of the affected arm, Hospital-based mCIT and Hospital-based TR in people with 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 8 inclusion and 0 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 28 Feb 2013. 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?
Kinematic assessment (time frame: up to six years). 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 28 Feb 2013.