NCT02156713

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 2, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 5, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

February 4, 2015

Status Verified

February 1, 2015

Enrollment Period

4 months

First QC Date

June 2, 2014

Last Update Submit

February 3, 2015

Conditions

Keywords

HemiparesisOccupational Therapy

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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.

    Week 5

Study Arms (1)

CIMT Camp

EXPERIMENTAL

Members of this study will participate in the group CIMT camp.

Behavioral: CIMT Camp

Interventions

CIMT CampBEHAVIORAL
CIMT Camp

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Lack of hand function
  • Fixed contractures
  • Active seizures
  • High tone
  • Medical instability
  • Non-English speaking parents.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Cerebral PalsyParesis

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kelly J Tanner, MOT

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 2, 2014

First Posted

June 5, 2014

Study Start

May 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

February 4, 2015

Record last verified: 2015-02

Locations