Intensive Group Based CIMT for Young Children

NCT ID: NCT06330831

Last Updated: 2024-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-09
• Study Completion Date: 2023-07-01

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.

Conditions

Hemiplegic Cerebral Palsy; Non-Accidental Traumatic Head Injury to Child

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intensive, Group Based CIMT

The intensive, group based CIMT program lasted for 3 hours/day x 5 days/week x 4 weeks. Children wore a cast on their non-affected arm for 24 hours/day for 3 weeks. During the last week, the cast was removed to focus on bimanual skills. Occupational therapists ran and were present for every hour of the program. Both physical therapy and speech language pathology cotreated for 1 1/2 hours two times per week and either music, art, or adaptive martial arts occurred 1 hour per week. Interns and volunteers served as intervention assistants to maintain a 2:1 or 1:1 child to therapist/interventionist ratio. The same theme-based lesson plans were used for the 2-3-year-old program and the 4-6-year-old program. Each age group program offered spots for 3-6 children to attend per year except for 2020 when the programs were suspended due to COVID 19 pandemic.

Group Type: EXPERIMENTAL

Intensive, Group Based Constraint Induced Therapy (CIMT)

Intervention Type: OTHER

See arm description. Children who were in study 2 received two consecutive episodes of the intensive, group based CIMT intervention (episode 1 during the first summer, episode 2 during the following summer).

Interventions

Intensive, Group Based Constraint Induced Therapy (CIMT)

See arm description. Children who were in study 2 received two consecutive episodes of the intensive, group based CIMT intervention (episode 1 during the first summer, episode 2 during the following summer).

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Months
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ability KC

UNKNOWN

Sponsor Role: collaborator

Rockhurst University

OTHER

Sponsor Role: lead

Responsible Party

Katie Ryan-Bloomer

Associate Professor of Occupational Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katherine S Ryan-Bloomer

Role: PRINCIPAL_INVESTIGATOR

Associate Professor of OT Rockhurst University; Occupational Therapist at Ability KC

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Other Identifiers

x2ghr8pc

Identifier Type: -

Identifier Source: org_study_id