Neurological InjuryNCT02875054
Camp High 5: Evaluation of the Effect on Upper Limb Function
A study testing Constraint induced movement therapy (CIMT) and Hand-arm bimanual intensive training (HABIT) in people with Neurological Injury and Hemiplegia, run by NYU Langone Health at 1 site in United States.
Trial summary
Randomized control trial to evaluate uni-manual and bimanual upper limb function as well as compare outcomes of varied cast wear in children with hemiplegic cerebral palsy (CP) following a hybrid camp model of modified constraint induced movement therapy (mCIMT) and hand-arm bimanual intensive training (HABIT). Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Neurological Injury, Hemiplegia
- What is being tested?
- Constraint induced movement therapy (CIMT) and Hand-arm bimanual intensive training (HABIT)
- 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
- Jun 2016to 1 Jan 2017
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants will range from 2 years to 11 years 11 months of age at time of enrollment. Children under 5 years of age will attend a morning session and children 6 years and older will attend an -Diagnosis: hemiplegia resulting from a neurological Injury
- Manual Ability Classification System or Mini Manual Ability Classification System classification I-III
Who cannot join
- Botox injection within past 6 months or planned for within 6 months post camp
- Inability to follow commands
- Family unable to commit to daily sessions for 4 weeks
- Unable to tolerate assigned casting protocol (3-24 hours) daily for 4 weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Camp High 5 2016: Evaluation of the Effect on Upper Limb Function
Randomized control trial to evaluate uni-manual and bimanual upper limb function as well as compare outcomes of varied cast wear in children with hemiplegic cerebral palsy (CP) following a hybrid camp model of modified constraint induced movement therapy (mCIMT) and hand-arm bimanual intensive training (HABIT).
- Conditions
- Neurological Injury, Hemiplegia
- Being tested
- Constraint induced movement therapy (CIMT), Hand-arm bimanual intensive training (HABIT)
- Medical subject headings
- Trauma, Nervous System, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constraint induced movement therapy (CIMT)Behavioural
Involves forcing use of ones affected upper extremity (UE) by physically restraining the less affected upper extremity
Hand-arm bimanual intensive training (HABIT)Behavioural
Facilitates the translation of gains to improve goal-directed bimanual performance.
| Study group | Role | What they receive |
|---|---|---|
| Continued Casting | Active comparator | Participants with 24 hour cast wear (continued casting) for the entire duration of the constraint portion of camp (2 initial weeks). Receives: Behavioral: Constraint induced movement therapy (CIMT); Behavioral: Hand-arm bimanual intensive training (HABIT) |
| Intermittent Casting | Active comparator | Participants who wear a univalve cast for 3 hours of constraint camp with home exercise program of 2 hours cast wear on the weekends (intermittent casting). Receives: Behavioral: Constraint induced movement therapy (CIMT); Behavioral: Hand-arm bimanual intensive training (HABIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Motor Activity Log
parent questionnaire to determine how well and how often the family perceives the child Spontaneously uses their affected Upper Extremity throughout the day at home. This assessment is scored by adding up the parental score and getting an average score.
Measured: 6 Months
Assisting Hand Assessment
Test of hand function in children with difficulties using one of their hands. The AHA measures how effectively the affected hand and arm is used in bimanual performance.
Measured: 6 Months
Melbourne-2
Test of unilateral upper limb function is a validated and reliable tool for evaluating quality of upper limb movement in children with neurological conditions aged 2.5 to 15 years.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startJun 2016
- Primary completion1 Jan 2017
- Study completion1 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurological InjuryStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renat Sukhov, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875054
- Sponsor's protocol ID
- 16-00990
- Status last verified
- Apr 2017
- First submitted
- 12 Aug 2016
- Last updated
- 21 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Camp High 5 2016: Evaluation of the Effect on Upper Limb Function
- ClinicalTrials.gov ID
- NCT02875054
- Acronym / sponsor ID
- 16-00990
- Conditions
- Neurological Injury, Hemiplegia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 23 Aug 2016 (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.
Randomized control trial to evaluate uni-manual and bimanual upper limb function as well as compare outcomes of varied cast wear in children with hemiplegic cerebral palsy (CP) following a hybrid camp model of modified constraint induced movement therapy (mCIMT) and hand-arm bimanual intensive training (HABIT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continued Casting | Active comparator | Behavioral: Constraint induced movement therapy (CIMT), Behavioral: Hand-arm bimanual intensive training (HABIT)Participants with 24 hour cast wear (continued casting) for the entire duration of the constraint portion of camp (2 initial weeks). |
| Intermittent Casting | Active comparator | Behavioral: Constraint induced movement therapy (CIMT), Behavioral: Hand-arm bimanual intensive training (HABIT)Participants who wear a univalve cast for 3 hours of constraint camp with home exercise program of 2 hours cast wear on the weekends (intermittent casting). |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Participants will range from 2 years to 11 years 11 months of age at time of enrollment. Children under 5 years of age will attend a morning session and children 6 years and older will attend an -Diagnosis: hemiplegia resulting from a neurological Injury
- Manual Ability Classification System or Mini Manual Ability Classification System classification I-III
Key exclusion criteria (4 listed)
- Botox injection within past 6 months or planned for within 6 months post camp
- Inability to follow commands
- Family unable to commit to daily sessions for 4 weeks
- Unable to tolerate assigned casting protocol (3-24 hours) daily for 4 weeks
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 |
|---|---|---|
| Constraint induced movement therapy (CIMT)Involves forcing use of ones affected upper extremity (UE) by physically restraining the less affected upper extremity | Behavioural | Continued Casting, Intermittent Casting |
| Hand-arm bimanual intensive training (HABIT)Facilitates the translation of gains to improve goal-directed bimanual performance. | Behavioural | Continued Casting, Intermittent Casting |
Primary outcome
Pediatric Motor Activity Log
Time frame: 6 Months
parent questionnaire to determine how well and how often the family perceives the child Spontaneously uses their affected Upper Extremity throughout the day at home. This assessment is scored by adding up the parental score and getting an average score.
Assisting Hand Assessment
Time frame: 6 Months
Test of hand function in children with difficulties using one of their hands. The AHA measures how effectively the affected hand and arm is used in bimanual performance.
Melbourne-2
Time frame: 6 Months
Test of unilateral upper limb function is a validated and reliable tool for evaluating quality of upper limb movement in children with neurological conditions aged 2.5 to 15 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 21 Apr 2017.
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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.
Renat Sukhov, MD principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Constraint induced movement therapy (CIMT) and Hand-arm bimanual intensive training (HABIT) in people with Neurological Injury and Hemiplegia, run by NYU Langone Health 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 2 inclusion and 4 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 21 Apr 2017. 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?
Pediatric Motor Activity Log (time frame: 6 Months). 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 21 Apr 2017.