Cerebral PalsyNCT02156713
Constraint Induced Movement Therapy Summer Camp
A study testing CIMT Camp in people with Cerebral Palsy and Cerebral Palsy, Diplegic, Infantile, run by Kelly Tanner at 1 site in United States.
Trial summary
Constraint induced movement therapy (CIMT) is an intervention for unilateral cerebral palsy (CP). It is currently part of standard of care for children with unilateral CP, but is typically done one-on-one and with the child wearing a cast 24 hours a day during the duration of treatment. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Cerebral Palsy, Cerebral Palsy, Diplegic, Infantile
- What is being tested?
- CIMT Camp
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Sep 2014
- 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 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Scores of level I, II or III on the Manual Ability Classification System
- Independent grasp
- Ability to ambulate independently or with an assistive device
- Sufficient cooperation and cognitive understanding to participate in a group.
Who cannot join
- Lack of hand function
- Fixed contractures
- Active seizures
- High tone
- Medical instability
- Non-English speaking parents.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Constraint Induced Movement Therapy Summer Camp for Children With Unilateral Cerebral Palsy Ages 3-7
Constraint induced movement therapy (CIMT) is an intervention for unilateral cerebral palsy (CP). It is currently part of standard of care for children with unilateral CP, but is typically done one-on-one and with the child wearing a cast 24 hours a day during the duration of treatment. The purpose of this study is to assess the effects of an intensive group-based CIMT summer camp in which participants wear a removable cast on upper extremity function, occupational performance, and patient-specific goals. The investigators hypothesize that upper extremity skills and occupational performance will increase, and that patients will reach their individualized goals.
- Being tested
- CIMT Camp
- Keywords
- Hemiparesis, Occupational Therapy
- Medical subject headings
- Cerebral Palsy, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CIMT CampBehavioural
| Study group | Role | What they receive |
|---|---|---|
| CIMT Camp | Experimental | Members of this study will participate in the group CIMT camp. Receives: Behavioral: CIMT Camp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Canadian Occupational Performance Measure Score
The Canadian Occupational Performance Measure asks parents to rate their child's level of occupational performance as well as how satisfied they are with it both before and after treatment.
Measured: Week 5
Goal Attainment Scaling
Parents and therapists identify appropriate goals for the child to achieve at the end of therapy. The therapist then identifies "levels of attainment" for each individual goal.
Measured: Week 5
Change in Manual Ability Classification System Level
The Manual Ability Classification System is an observation-based measure of upper extremity function in individuals with cerebral palsy.
Measured: Week 5
Change in Pediatric Motor Activity Log Score
This caregiver questionnaire addresses how often and how well a child uses his or her affected extremity outside of the therapy setting.
Measured: Week 5
Change in Quality of Upper Extremity Skills Test Score
This is an observation-based measure during which the therapist evaluates the quality of an individual's upper extremity movement with regard to dissociated movement, grasp, protective extension, and weight bearing.
Measured: Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionSep 2014
- Study completionSep 2014
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kelly Tanner
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kelly Tanner, Nationwide Children's Hospital
- Investigators
- Kelly J Tanner, MOT, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02156713
- Sponsor's protocol ID
- IRB14-00197
- Status last verified
- Feb 2015
- First submitted
- 2 Jun 2014
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Constraint Induced Movement Therapy Summer Camp for Children With Unilateral Cerebral Palsy Ages 3-7
- ClinicalTrials.gov ID
- NCT02156713
- Acronym / sponsor ID
- IRB14-00197
- Keywords
- Hemiparesis, Occupational Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Kelly TannerUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 5 Jun 2014 (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.
Constraint induced movement therapy (CIMT) is an intervention for unilateral cerebral palsy (CP). It is currently part of standard of care for children with unilateral CP, but is typically done one-on-one and with the child wearing a cast 24 hours a day during the duration of treatment. The purpose of this study is to assess the effects of an intensive group-based CIMT summer camp in which participants wear a removable cast on upper extremity function, occupational performance, and patient-specific goals. The investigators hypothesize that upper extremity skills and occupational performance will increase, and that patients will reach their individualized goals.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CIMT Camp | Experimental | Behavioral: CIMT CampMembers of this study will participate in the group CIMT camp. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Scores of level I, II or III on the Manual Ability Classification System
- Independent grasp
- Ability to ambulate independently or with an assistive device
- Sufficient cooperation and cognitive understanding to participate in a group.
Key exclusion criteria (6 listed)
- Lack of hand function
- Fixed contractures
- Active seizures
- High tone
- Medical instability
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 |
|---|---|---|
| CIMT Camp | Behavioural | CIMT Camp |
Primary outcome
Change in Canadian Occupational Performance Measure Score
Time frame: Week 5
The Canadian Occupational Performance Measure asks parents to rate their child's level of occupational performance as well as how satisfied they are with it both before and after treatment.
Goal Attainment Scaling
Time frame: Week 5
Parents and therapists identify appropriate goals for the child to achieve at the end of therapy. The therapist then identifies "levels of attainment" for each individual goal.
Change in Manual Ability Classification System Level
Time frame: Week 5
The Manual Ability Classification System is an observation-based measure of upper extremity function in individuals with cerebral palsy.
Change in Pediatric Motor Activity Log Score
Time frame: Week 5
This caregiver questionnaire addresses how often and how well a child uses his or her affected extremity outside of the therapy setting.
Change in Quality of Upper Extremity Skills Test Score
Time frame: Week 5
This is an observation-based measure during which the therapist evaluates the quality of an individual's upper extremity movement with regard to dissociated movement, grasp, protective extension, and weight bearing.
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 4 Feb 2015.
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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.
Kelly J Tanner, MOT principal investigator
Nationwide Children's 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 CIMT Camp in people with Cerebral Palsy and Cerebral Palsy, Diplegic, Infantile, run by Kelly Tanner at 1 site in United States.
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 4 Feb 2015. 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 United States. 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?
Change in Canadian Occupational Performance Measure Score (time frame: Week 5). The study lists 5 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 4 Feb 2015.