Clinical trial NCT06330831: Intensive Group Based CIMT for Young Children
Official title: Measuring the Effectiveness of Intensive Group Based CIMT for Young Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegic Cerebral Palsy
Non-Accidental Traumatic Head Injury to Child
Keywords: Constraint Induced Movement Therapy
Pediatrics
Group Based
Intensive
Young children
Lead sponsor: Rockhurst University
Sponsor class: OTHER
Collaborators: name: Ability KC
First posted: 2024-03-26
Enrollment: 35
Sex: ALL
Minimum age (years): 20
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Study 1 is a single group pre-post study of children who received 1 episode of the intensive, group based CIMT intervention (2 data points- pre CIMT 1 and post CIMT1). Study 2 is a repeated measures design to evaluate the long-term effects of the first episode and the effects of the second episode of intensive group based CIMT (4 data points- pre CIMT1; post CIMT1 (at the end of 1 month intervention); pre CIMT 2- 11 months after post of CIMT1; post CIMT 2- 12 months post CIMT 1)
Primary purpose: TREATMENT

Brief summary: This project aims to investigate the effectiveness of an intensive, group-based Constraint Induced Movement Therapy (CIMT) program for young children ages 2-6 years with unilateral hemiparesis, or weakness on one side of the body. This project involves two studies. Study 1 investigates the effect of one dosage of a 1-month, intensive group based CIMT summer program. Study 2 investigates the effect of a repeated, consecutive episode of the intensive, group based CIMT program for children who attended the program the following summer.

Detailed description: Children with hemiparesis, or weakness on one side of the body, caused by neurological conditions such as cerebral palsy or brain injury often experience difficulty using their arm and hand on their affected side (unilateral function), using both arms together (bimanual coordination) and participating in meaningful activities (occupational performance). Constraint Induced Movement Therapy (CIMT) has become one of the most evidence-based treatments for children with unilateral hemiplegia. Constraint Induced Movement Therapy involves constraining the non-affected arm and hand using a cast or sling to promote the use of the affected hand. Though CIMT offered on an individual basis to children in their own homes has been found to be effective, there are disadvantages to individual, signature models or caregiver delivered models of CIMT which include cost, decreased in number of children who can receive the therapy, and caregiver burden. Group based CIMT offers an alternative model of delivery for CIMT intervention that alleviates some of the challenges. The goal of this overall project was to evaluate the effectiveness of an intensive, group-based Constraint Induced Movement Therapy (CIMT) program for young children ages 20 months through 6 years of age with hemiparesis. The children attended a month-long intensive, group based CIMT program lasting 3 hours/day x 5 days/week x 4 weeks. For the first 3 weeks the children wore a cast on their non-affected arm for nearly 24 hours a day. During the last week of the program, the occupational therapists removed the cast and focused on bimanual skills (using both hands together). The children participated in testing that measured unilateral function (performance of the weaker arm such as range of motion, grasp, ability to bear weight or catch self), bimanual coordination (the ability to use both hands for functional tasks such as holding a toy, cutting food), and occupational performance (the ability to participate in meaningful daily activities- dressing, play, school-related activities). Study 1 analyzed the effects of a single dosage of the CIMT intervention (attending the program for one month). The investigators hypothesized (predicted) that following the study, the children would statistically significantly improve unimanual function, bimanual coordination, and occupational performance. Study 2 analyzed the effects of two, consecutive episodes of CIMT intervention (attending the CIMT program for 2 summers in a row). The researcher hypothesized children would display statistically significant improvements in unimanual function, bimanual coordination, and occupational performance after each episode.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of unilateral hemiparesis
* Between the ages of 20 mos.- 6 yrs 11 mos. 30 days
* Authorized through insurance or scholarship to attend the CIMT summer program
* Manual Ability Classification Scale or Mini-MACS level of 1-4
* Able to follow simple commands.

Exclusion Criteria:

* If in child protective service custody since videographic information for QUEST and AHA assessments could not be obtained
* If receiving additional OT therapy during the intensive, group based CIMT program
* If missed more than 3 days of the group based CIMT intervention

Primary outcomes:
measure: Quality Upper Extremity Skills Evaluation Test (QUEST)
timeFrame: Study 1: Pre-intervention assessment= within 1 month of start of program, post-intervention = at the end of 1 month program. Study 2: CIMT 2 pre-assessment= 11 months following episode 1 , CIMT 2 post-assessment = 12 months following episode 1
measure: Assisting Hand Assessment (AHA)
timeFrame: Study 1: Pre-intervention assessment= within 1 month of start of program, post-intervention = at the end of 1 month program. Study 2: CIMT 2 pre-assessment= 11 months following episode 1 , CIMT 2 post-assessment = 12 months following episode 1
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Study 1: Pre-intervention assessment= within 1 month of start of program, post-intervention = at the end of 1 month program. Study 2: CIMT 2 pre-assessment= 11 months following episode 1 , CIMT 2 post-assessment = 12 months following episode 1
measure: Pediatric Evaluation Disability Inventory (PEDI)
timeFrame: Study 1: Pre-intervention assessment= within 1 month of start of program, post-intervention = at the end of 1 month program. Study 2: CIMT 2 pre-assessment= 11 months following episode 1 , CIMT 2 post-assessment = 12 months following episode 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Associate Professor of OT Rockhurst University; Occupational Therapist at Ability KC
name: Katherine S Ryan-Bloomer
role: PRINCIPAL_INVESTIGATOR
References:
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