Intensive Group Based CIMT for Young Children

Hemiplegic Cerebral Palsy Clinical Trial

Official title:

Measuring the Effectiveness of Intensive Group Based CIMT for Young Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06330831
• Other study ID #: x2ghr8pc
• Status: Completed
• Phase: N/A
• Start date: May 9, 2016
• Est. completion date: July 1, 2023

Study information

• Verified date: March 2024
• Source: Rockhurst University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: July 1, 2023
• Est. primary completion date: June 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Months to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Craniocerebral Trauma
• Hemiplegic Cerebral Palsy
• Non-Accidental Traumatic Head Injury to Child

Intervention

Other:
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Rockhurst University	Ability KC

References & Publications (13)

Chiu HC, Ada L. Constraint-induced movement therapy improves upper limb activity and participation in hemiplegic cerebral palsy: a systematic review. J Physiother. 2016 Jul;62(3):130-7. doi: 10.1016/j.jphys.2016.05.013. Epub 2016 Jun 17. — View Citation

Cohen-Holzer M, Katz-Leurer M, Reinstein R, Rotem H, Meyer S. The effect of combining daily restraint with bimanual intensive therapy in children with hemiparetic cerebral palsy: a self-control study. NeuroRehabilitation. 2011;29(1):29-36. doi: 10.3233/NRE-2011-0674. — View Citation

Gelkop N, Burshtein DG, Lahav A, Brezner A, Al-Oraibi S, Ferre CL, Gordon AM. Efficacy of constraint-induced movement therapy and bimanual training in children with hemiplegic cerebral palsy in an educational setting. Phys Occup Ther Pediatr. 2015 Feb;35(1):24-39. doi: 10.3109/01942638.2014.925027. Epub 2014 Jul 1. — View Citation

James S, Ziviani J, Boyd R. A systematic review of activities of daily living measures for children and adolescents with cerebral palsy. Dev Med Child Neurol. 2014 Mar;56(3):233-44. doi: 10.1111/dmcn.12226. Epub 2013 Aug 13. — View Citation

Krumlinde-Sundholm L, Holmefur M, Kottorp A, Eliasson AC. The Assisting Hand Assessment: current evidence of validity, reliability, and responsiveness to change. Dev Med Child Neurol. 2007 Apr;49(4):259-64. doi: 10.1111/j.1469-8749.2007.00259.x. — View Citation

Law M, Baptiste S, McColl M, Opzoomer A, Polatajko H, Pollock N. The Canadian occupational performance measure: an outcome measure for occupational therapy. Can J Occup Ther. 1990 Apr;57(2):82-7. doi: 10.1177/000841749005700207. — View Citation

McColl MA, Denis CB, Douglas KL, Gilmour J, Haveman N, Petersen M, Presswell B, Law M. A Clinically Significant Difference on the COPM: A Review. Can J Occup Ther. 2023 Mar;90(1):92-102. doi: 10.1177/00084174221142177. Epub 2023 Jan 17. — View Citation

Regalado A, Decker B, Flaherty BM, Zimmer L, Brown I. Effectiveness of Constraint-Induced Movement Therapy for Children With Hemiparesis Associated With Cerebral Palsy: A Systematic Review. Am J Occup Ther. 2023 May 1;77(3):7703205160. doi: 10.5014/ajot.2023.050152. — View Citation

Thorley M, Lannin N, Cusick A, Novak I, Boyd R. Reliability of the quality of upper extremity skills test for children with cerebral palsy aged 2 to 12 years. Phys Occup Ther Pediatr. 2012 Feb;32(1):4-21. doi: 10.3109/01942638.2011.602389. Epub 2011 Aug 15. — View Citation

Tinderholt Myrhaug H, Ostensjo S, Larun L, Odgaard-Jensen J, Jahnsen R. Intensive training of motor function and functional skills among young children with cerebral palsy: a systematic review and meta-analysis. BMC Pediatr. 2014 Dec 5;14:292. doi: 10.1186/s12887-014-0292-5. — View Citation

Walker C, Shierk A, Roberts H. Constraint Induced Movement Therapy in Infants and Toddlers with Hemiplegic Cerebral Palsy: A Scoping Review. Occup Ther Health Care. 2022 Jan;36(1):29-45. doi: 10.1080/07380577.2021.1953206. Epub 2021 Aug 2. — View Citation

Wang TN, Liang KJ, Liu YC, Shieh JY, Chen HL. Effects of Intensive Versus Distributed Constraint-Induced Movement Therapy for Children With Unilateral Cerebral Palsy: A Quasi-Randomized Trial. Neurorehabil Neural Repair. 2023 Feb-Mar;37(2-3):109-118. doi: 10.1177/15459683231162330. Epub 2023 Mar 28. — View Citation

Wu WC, Hung JW, Tseng CY, Huang YC. Group constraint-induced movement therapy for children with hemiplegic cerebral palsy: a pilot study. Am J Occup Ther. 2013 Mar-Apr;67(2):201-8. doi: 10.5014/ajot.2013.004374. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality Upper Extremity Skills Evaluation Test (QUEST)	The Quality Upper Extremity Skills Evaluation Test (QUEST) is a standardized assessment that has the child perform various movements to assess the function of the non-affected arm and the hemiparetic arm in four subtests: Dissociated Movements, Grasps, Weight Bearing and Protective Extension. The children perform reaching, turning forearm over, grasping and releasing of various toys, leaning through their arms in various positions, and catching themselves when tipped out of their base of support in various positions. The QUEST has been standardized with children with unilateral cerebral palsy. Children were videotaped while participating in the QUEST and the principal investigator, clinical investigators, and trained OT students scored the QUEST for this study.	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
Primary	Assisting Hand Assessment (AHA)	The Assisting Hand Assessment (AHA) is a standardized criterion test which measures children's ability to use the affected hand as an assisting hand when manipulating numerous toys that require two hands. The AHA is a play-based assessment where the children video recorded while playing with various toys. A certified AHA rater (which the principal investigator is) reviews the video and scores the children on 22 items. A total sum score and scaled score percentile can be generated. The AHA Kids version was standardized on children 18 months to 12 years of age on children with cerebral palsy and brachioplexus injury. The AHA has been used in numerous research studies and shows good responsiveness to change in performance from before to after intervention.	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
Primary	Canadian Occupational Performance Measure (COPM)	The Canadian Occupational Performance Measure (COPM) is a standardized assessment that measures occupational performance of and satisfaction of performance of meaningful, individualized goals. Clients identify five most important areas of occupational difficulty within the domains of self-care, productivity, and leisure. Parents of children under the age of 8 years, rate the child's performance on a scale of one (poor performance) to 10 (nearly perfect performance) and satisfaction of one (not satisfied at all) to 10 (very satisfied). The scores for performance and satisfaction can be summed to give a performance total and satisfaction total. Many studies have demonstrated the COPM displays good responsiveness to change, meaning this assessment can easily detect change in performance and satisfaction from before to after intervention.	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
Primary	Pediatric Evaluation Disability Inventory (PEDI)	The Pediatric Evaluation Disability Inventory (PEDI) assesses children's functional skill ability within the domains of selfcare, mobility, and social function. The parents rate a child's performance as capable or unable on discrete skills within each domain. The parents also rate the level of assistance they provide the child on the Caregiver Assistance Scale from total assistance to none (child independence). The caregivers also rate the level of modifications needed for each subdomain. The original PEDI was standardized on children with and without disabilities from 6 months to 7 1/2 years of age. The PEDI has been used in other CIMT studies as a measure of occupational performance with some responsivity. Only the selfcare and social function domains were used for this study.	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