Hemiplegic Cerebral PalsyNCT06330831
Intensive Group Based CIMT for Young Children
A study testing Intensive, Group Based Constraint Induced Therapy (CIMT) in people with Hemiplegic Cerebral Palsy and Non-Accidental Traumatic Head Injury to Child, run by Rockhurst University.
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. Read more about this study
- Who is it for?
- Ages 20 months to 6 years
- Conditions the study is for
- Hemiplegic Cerebral Palsy, Non-Accidental Traumatic Head Injury to Child
- What is being tested?
- Intensive, Group Based Constraint Induced Therapy (CIMT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 9 May 2016to 1 Jul 2023
- 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 20 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: Measuring the Effectiveness of Intensive Group Based CIMT for Young Children
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.
Read the 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.
- Being tested
- Intensive, Group Based Constraint Induced Therapy (CIMT)
- Keywords
- Constraint Induced Movement Therapy, Pediatrics, Group Based, Intensive, Young children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive, Group Based Constraint Induced Therapy (CIMT)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).
| Study group | Role | What they receive |
|---|---|---|
| Intensive, Group Based CIMT | Experimental | 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. Receives: Other: Intensive, Group Based Constraint Induced Therapy (CIMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start9 May 2016
- Primary completion28 Jun 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Hemiplegic Cerebral PalsyStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- 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)
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rockhurst University
- Sponsor type
- University, hospital or other
- Collaborators
- Ability KC
- Responsible party
- Principal investigator, Katie Ryan-Bloomer, Rockhurst University
- Investigators
- Katherine S Ryan-Bloomer, Principal investigator, Associate Professor of OT Rockhurst University; Occupational Therapist at Ability KC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330831
- Sponsor's protocol ID
- x2ghr8pc
- Status last verified
- Mar 2024
- First submitted
- 5 Mar 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21838618Krumlinde-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.
PubMed 17376135Law 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.
PubMed 10104738McColl 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.
PubMed 36650928James 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.
PubMed 23937056Regalado 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.
PubMed 37358836Chiu 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.
PubMed 27323932Tinderholt 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.
PubMed 25475608Walker 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.
PubMed 34339315Wang 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.
PubMed 36987387Wu 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.
PubMed 23433275Gelkop 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.
PubMed 24983295Cohen-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.
PubMed 21876293
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Effectiveness of Intensive Group Based CIMT for Young Children
- ClinicalTrials.gov ID
- NCT06330831
- Acronym / sponsor ID
- x2ghr8pc
- Keywords
- Constraint Induced Movement Therapy, Pediatrics, Group Based, Intensive, Young children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Rockhurst UniversityUniversity, hospital or other
- Collaborators
- Ability KC
- Study start
- 9 May 2016 (actual)
- Primary completion
- 28 Jun 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 26 Mar 2024 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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)
| Arm | Type | Receives |
|---|---|---|
| Intensive, Group Based CIMT | Experimental | Other: Intensive, Group Based Constraint Induced Therapy (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. |
Who may qualify
- Ages
- 20 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| 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). | Other | Intensive, Group Based CIMT |
Primary outcome
Quality Upper Extremity Skills Evaluation Test (QUEST)
Time frame: 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
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.
Assisting Hand Assessment (AHA)
Time frame: 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
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.
Canadian Occupational Performance Measure (COPM)
Time frame: 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
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.
Pediatric Evaluation Disability Inventory (PEDI)
Time frame: 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
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.
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 26 Mar 2024.
- Background: PubMed 21838618Thorley 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.
- Background: PubMed 17376135Krumlinde-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.
- Background: PubMed 10104738Law 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.
- Background: PubMed 36650928McColl 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.
- Background: PubMed 23937056James 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.
- Background: PubMed 37358836Regalado 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.
- Background: PubMed 27323932Chiu 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.
- Background: PubMed 25475608Tinderholt 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.
- Background: PubMed 34339315Walker 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.
- Background: PubMed 36987387Wang 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.
- Background: PubMed 23433275Wu 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.
- Background: PubMed 24983295Gelkop 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.
- Individual participant dataSharing planned: No
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Not yet recruiting
Virtual Reality-Augmented Constraint-Induced Movement Therapy Versus Conventional Constraint-Induced Therapy for Upper Limb Rehabilitation in Children With Unilateral Cerebral Palsy.
Cerebral Palsy Spastic Hemiplegic, Functionnal Neurological Disorder
Recruiting
Implementation of Therapy Together
Cerebral Palsy, Hemiplegic Cerebral Palsy
Recruiting
rTMS Treatment of Spasticity in Children With Cerebral Palsy/ Hemiplegia Due to ABI - a RCT
CP (Cerebral Palsy)
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.
Katherine S Ryan-Bloomer principal investigator
Associate Professor of OT Rockhurst University; Occupational Therapist at Ability KC
Questions about this trial
What is this clinical trial studying?
A study testing Intensive, Group Based Constraint Induced Therapy (CIMT) in people with Hemiplegic Cerebral Palsy and Non-Accidental Traumatic Head Injury to Child, run by Rockhurst University.
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 5 inclusion and 3 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 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Quality Upper Extremity Skills Evaluation Test (QUEST) (time frame: 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06330831, which also lists 13 linked publications.
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 26 Mar 2024.