Hemiplegic Cerebral PalsyCHAMP-TNCT05303883
Feasibility of Pediatric CIMT by Televideo
A study testing Pediatric Constrained Induced Movement Therapy in people with Hemiplegic Cerebral Palsy, run by Ohio State University at 3 sites in United States.
Trial summary
The study will test a remotely delivered, intensive, therapist-led, pediatric CIMT intervention, to improve the quality and frequency of upper limb movement during functional activity. Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Hemiplegic Cerebral Palsy
- What is being tested?
- Pediatric Constrained Induced Movement Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Apr 2022to 31 Oct 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 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ages 1 - 10 years old at enrollment;
- diagnosis of hemiplegic CP per parent report;
- ability to participate in therapy 3 hours/day x 5 days/week x 4 weeks (dose based on CHAMP RCT results).
Who cannot join
- uncontrolled seizures;
- medical or other complex conditions that preclude tolerance of 3 hours of intensive therapy per day
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Nationwide Children's Hospital
Columbus, Ohio, 43205
The Ohio State University
Columbus, Ohio, 43210
Virginia Polytechnic Institute and State University
Roanoke, Virginia, 24016
About this study
Official title: Feasibility of Pediatric Constraint Induced Movement Therapy Delivered Remotely for Children With Hemiplegic Cerebral Palsy
The study will test a remotely delivered, intensive, therapist-led, pediatric CIMT intervention, to improve the quality and frequency of upper limb movement during functional activity. We will evaluate: remote assessment of patient motor outcomes; computer-based video interaction for parent training in shaping therapeutic activities; child, parent, and therapist interactions; remote delivery of treatment; and the usability and usefulness of technology (e.g. reliability of internet connection; video streaming). As a final product, the study will yield a feasible and acceptable tele-rehabilitation protocol that meets our fidelity and reliability criteria and is ready for larger-scale efficacy testing in children with hemiplegic CP, ages 1-10 years.
Read the detailed description
Cerebral palsy (CP) is a public health problem that affects 2-3 per 1000 children. Up to 75 % of children with cerebral palsy will have motor impairments that can lead to lifelong disability, therefore there is a need for effective treatment of these motor impairments. A body of evidence shows that intensive motor therapies can improve arm and hand (upper limb) motor function in children with CP. Constraint induced movement therapy (CIMT) is one of the motor therapies with the strongest evidence base for its effectiveness. Our team has developed an innovative CIMT protocol to treat upper limb impairments due to CP. This protocol combines 1) high dosage of motor treatments, (up to 3-6 hours of therapy per day for 20 days); 2) constraint of the unaffected arm, 3) the incorporation of behavior motivation techniques to encourage the child to perform increasingly complex motor tasks; 4) treatment within the home to promote generalization of the motor behaviors; and 5) a post-therapy treatment plan for the parents to continue after the formal CIMT protocol is done. In a recent randomized controlled trial, we tested the effect of this CIMT protocol on upper limb function in children with hemiplegic CP. Children who received CIMT at the 30-hour and 60-hour doses had significantly better function immediately post-treatment than children who received usual and customary care. This difference persisted at 6 months after treatment for the children who received the 60-hour dose. These results provide clear evidence that the higher therapy dose resulted in greater sustained improvement of upper limb function.
Through our work in this and other clinical trials, we recognized that our treatment protocol delivered in the home cannot be delivered to children who live in rural areas beyond the reach of our therapists or in urban communities whose families are unable to have therapists work in their homes for 20 days. This limitation disproportionately affects families who live in medically resource poor areas. To address this barrier to access, we propose to modify our CIMT protocol so it can be used for telehealth delivery. Rehabilitation by telehealth has drawn considerable attention in the adult stroke world. A small number of trials in adult stroke patients and a small pilot trial in pediatric patients with upper limb weakness have shown that upper limb rehabilitation by telehealth is feasible and can be as effective as that delivered in the clinic.
Based on this emerging evidence, we will test the feasibility of our CIMT protocol adapted for telerehabilitation. In a related study, we will refine our CIMT by soliciting the input of families and children who have undergone CIMT treatment, and the input of expert treating therapists and assessors regarding our protocol. In the current study, we will test this refined protocol in a pilot sample of five to seven children ages 1-10 years who have hemiplegic CP. We will evaluate whether the remotely delivered treatment maintains fidelity to the original version delivered in person; whether the treatment is feasible to deliver, and whether it is acceptable to families, therapists, and assessors. In addition, we will evaluate whether the remote assessment of fine and gross motor skills is feasible, reliable, and acceptable. These measures will be assessed by questionnaires, observation of assessment recordings, scoring of the outcome measure, and interviews of parents of and participating children (the primary stakeholders), as well as feedback from study assessors.
Our long-term goal is to implement effective, accessible, intensive upper-limb interventions for children with hemiparesis, using delivery methods that are accessible, available, and feasible for families representing socioeconomic, geographic, and racial/ethnic diversity. This clinical research study is an important step toward clinical implementation through translation of an evidence-based intervention to a potentially more accessible, practical and equitable delivery method for families of children with CP.
- Conditions
- Hemiplegic Cerebral Palsy
- Being tested
- Pediatric Constrained Induced Movement Therapy
- Keywords
- Motor impairments, Gross motor delays, Manual impairment, Upper extremity impairment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatric Constrained Induced Movement TherapyOther
Constraint of the child's less-impaired upper extremity for first 17 days of treatment. Children wear a removable, lightweight constraint for the first 17 of 20 therapy sessions.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric constraint induced therapy | Experimental | Constrained induced therapy for children with hemiplegic cerebral palsy. Three hours of therapy per day, for five days a week, for four weeks. Receives: Other: Pediatric Constrained Induced Movement Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Intervention Measure (FIM)
The Feasibility of Intervention Measure (FIM) will assess intervention feasibility with a four-item measure. The measure includes four statements about the plausibility of implementing the intervention (the intervention seems implementable; the intervention seems doable; the intervention seems possible; the intervention seems easy to use). Individuals rate the extent to which the agree with each statement on a five-level scale (completely disagree, disagree, neither agree or disagree, agree, completely agree).
Measured: Within 2 weeks of intervention completion
Acceptability of Intervention Measure (AIM)
Acceptability of Intervention will be assessed through a four-item measure (AIM). The measure includes four statements about the appeal of the intervention (e.g. I like the intervention; I welcome the intervention; the intervention meets my approval; the intervention is appealing to me). Individuals rate the extent to which the agree with each statement on a five-level scale (completely disagree, disagree, neither agree or disagree, agree, completely agree).
Measured: Within 2 weeks of intervention completion
Intervention Appropriateness Measure (IAM)
Intervention Appropriateness will be assessed through a four-item measure (IAM). The measure includes four statements about the relevance or pertinence of the intervention (e.g. the intervention seems suitable; the intervention seems applicable; the intervention seems fitting; the intervention seems like a good match). Individuals rate the extent to which the agree with each statement on a five-level scale (completely disagree, disagree, neither agree or disagree, agree, completely agree).
Measured: Within 2 weeks of intervention completion
Usefulness, Usability and Desirability Assessment (UUD)
The Usability of the remote delivery system (use of the iPad, Kubi robot; video upload) will be assessed with the UUD assessment. Usability includes three major components: usefulness, desirability, and usability. The UUD gathers data on usability (ease of use of the telehealth technology) (9 items), usefulness (value, relevance, and applicability of the telehealth technology) (10 items), and desirability (overall appeal or interest of the telehealth technology) (4 items). Items are rated a five-point Likert-type scale.
Measured: Within 2 weeks of intervention completion
Fidelity of Intervention Assessment
This instrument assesses the extent to which the therapist adhered to fifteen core constructs of the intervention protocol. Evidence of adherence to high quality pediatric rehabilitation elements includes 6 constructs that are scored as Present (present-some and present-strong) or Absent. Includes items such as "collaboration between parent and therapist" and "aligning therapy with child's goals". Evidence of core components of pediatric constraint induced movement therapy is scored as Present or Absent. Includes items such as "high intensity of intervention" and occurs in "natural environment". Total score is number of core components present.
Measured: Once per week during 4-week intervention period
Secondary outcomes (2)
Fidelity of Remote Assessment
Fidelity to remote assessment procedures will be determined through video coding of recorded remote assessment. The following will be coded: adherence to administration procedures, length of assessment, number of sessions to complete assessment, number of assessment items completed, and percentage of items completed.
Measured: Within one week following the assessment
Perceptions of Remote Assessment and Intervention
A semi-structured interview will be used to assess the perceptions of therapists, assessors, and parents about the process of remote delivery. There are fourteen open-ended questions about the remote assessment process, the remote intervention process, and the technology used to gather information and conduct the remote assessments and intervention. These will will be coded qualitatively and analyzed by content analysis to determine common perceptions of strengths and areas for improvement.
Measured: Within one week following the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start20 Apr 2022
- Primary completion18 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemiplegic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- All enrolled children will receive the intervention.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Nationwide Children's Hospital, Virginia Polytechnic Institute and State University
- Responsible party
- Principal investigator, Amy Darragh, Ohio State University
- Investigators
- Warren Lo, Principal investigator, Nationwide Children's HospitalAmy Darragh, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05303883
- Sponsor's protocol ID
- STUDY00001867
- Acronym
- CHAMP-T
- Status last verified
- Dec 2023
- First submitted
- 10 Mar 2022
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maus E, Rittler A, Amon K, Heathcock J, Lo W, DeLuca S, Darragh A. Exploring Parent Perspectives of Feasibility After Intensive Telerehabilitation for Children with Unilateral Cerebral Palsy: A Mixed Methods Study. J Dev Phys Disabil. 2026;38(3):543-562. doi: 10.1007/s10882-025-10033-9. Epub 2025 Sep 1.
PubMed 42221522
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Pediatric Constraint Induced Movement Therapy Delivered Remotely for Children With Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05303883
- Acronym / sponsor ID
- CHAMP-T / STUDY00001867
- Conditions
- Hemiplegic Cerebral Palsy
- Keywords
- Motor impairments, Gross motor delays, Manual impairment, Upper extremity impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Nationwide Children's Hospital, Virginia Polytechnic Institute and State University
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 18 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 31 Mar 2022 (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.
The study will test a remotely delivered, intensive, therapist-led, pediatric CIMT intervention, to improve the quality and frequency of upper limb movement during functional activity. We will evaluate: remote assessment of patient motor outcomes; computer-based video interaction for parent training in shaping therapeutic activities; child, parent, and therapist interactions; remote delivery of treatment; and the usability and usefulness of technology (e.g. reliability of internet connection; video streaming). As a final product, the study will yield a feasible and acceptable tele-rehabilitation protocol that meets our fidelity and reliability criteria and is ready for larger-scale efficacy testing in children with hemiplegic CP, ages 1-10 years.
Detailed description
Cerebral palsy (CP) is a public health problem that affects 2-3 per 1000 children. Up to 75 % of children with cerebral palsy will have motor impairments that can lead to lifelong disability, therefore there is a need for effective treatment of these motor impairments. A body of evidence shows that intensive motor therapies can improve arm and hand (upper limb) motor function in children with CP. Constraint induced movement therapy (CIMT) is one of the motor therapies with the strongest evidence base for its effectiveness. Our team has developed an innovative CIMT protocol to treat upper limb impairments due to CP. This protocol combines 1) high dosage of motor treatments, (up to 3-6 hours of therapy per day for 20 days); 2) constraint of the unaffected arm, 3) the incorporation of behavior motivation techniques to encourage the child to perform increasingly complex motor tasks; 4) treatment within the home to promote generalization of the motor behaviors; and 5) a post-therapy treatment plan for the parents to continue after the formal CIMT protocol is done. In a recent randomized controlled trial, we tested the effect of this CIMT protocol on upper limb function in children with hemiplegic CP. Children who received CIMT at the 30-hour and 60-hour doses had significantly better function immediately post-treatment than children who received usual and customary care. This difference persisted at 6 months after treatment for the children who received the 60-hour dose. These results provide clear evidence that the higher therapy dose resulted in greater sustained improvement of upper limb function.
Through our work in this and other clinical trials, we recognized that our treatment protocol delivered in the home cannot be delivered to children who live in rural areas beyond the reach of our therapists or in urban communities whose families are unable to have therapists work in their homes for 20 days. This limitation disproportionately affects families who live in medically resource poor areas. To address this barrier to access, we propose to modify our CIMT protocol so it can be used for telehealth delivery. Rehabilitation by telehealth has drawn considerable attention in the adult stroke world. A small number of trials in adult stroke patients and a small pilot trial in pediatric patients with upper limb weakness have shown that upper limb rehabilitation by telehealth is feasible and can be as effective as that delivered in the clinic.
Based on this emerging evidence, we will test the feasibility of our CIMT protocol adapted for telerehabilitation. In a related study, we will refine our CIMT by soliciting the input of families and children who have undergone CIMT treatment, and the input of expert treating therapists and assessors regarding our protocol. In the current study, we will test this refined protocol in a pilot sample of five to seven children ages 1-10 years who have hemiplegic CP. We will evaluate whether the remotely delivered treatment maintains fidelity to the original version delivered in person; whether the treatment is feasible to deliver, and whether it is acceptable to families, therapists, and assessors. In addition, we will evaluate whether the remote assessment of fine and gross motor skills is feasible, reliable, and acceptable. These measures will be assessed by questionnaires, observation of assessment recordings, scoring of the outcome measure, and interviews of parents of and participating children (the primary stakeholders), as well as feedback from study assessors.
Our long-term goal is to implement effective, accessible, intensive upper-limb interventions for children with hemiparesis, using delivery methods that are accessible, available, and feasible for families representing socioeconomic, geographic, and racial/ethnic diversity. This clinical research study is an important step toward clinical implementation through translation of an evidence-based intervention to a potentially more accessible, practical and equitable delivery method for families of children with CP.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled children will receive the intervention.
| Arm | Type | Receives |
|---|---|---|
| Pediatric constraint induced therapy | Experimental | Other: Pediatric Constrained Induced Movement TherapyConstrained induced therapy for children with hemiplegic cerebral palsy. Three hours of therapy per day, for five days a week, for four weeks. |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ages 1 - 10 years old at enrollment;
- diagnosis of hemiplegic CP per parent report;
- ability to participate in therapy 3 hours/day x 5 days/week x 4 weeks (dose based on CHAMP RCT results).
Key exclusion criteria (2 listed)
- uncontrolled seizures;
- medical or other complex conditions that preclude tolerance of 3 hours of intensive therapy per day
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 |
|---|---|---|
| Pediatric Constrained Induced Movement TherapyConstraint of the child's less-impaired upper extremity for first 17 days of treatment. Children wear a removable, lightweight constraint for the first 17 of 20 therapy sessions. | Other | Pediatric constraint induced therapy |
Primary outcome
Feasibility of Intervention Measure (FIM)
Time frame: Within 2 weeks of intervention completion
The Feasibility of Intervention Measure (FIM) will assess intervention feasibility with a four-item measure. The measure includes four statements about the plausibility of implementing the intervention (the intervention seems implementable; the intervention seems doable; the intervention seems possible; the intervention seems easy to use). Individuals rate the extent to which the agree with each statement on a five-level scale (completely disagree, disagree, neither agree or disagree, agree, completely agree).
Acceptability of Intervention Measure (AIM)
Time frame: Within 2 weeks of intervention completion
Acceptability of Intervention will be assessed through a four-item measure (AIM). The measure includes four statements about the appeal of the intervention (e.g. I like the intervention; I welcome the intervention; the intervention meets my approval; the intervention is appealing to me). Individuals rate the extent to which the agree with each statement on a five-level scale (completely disagree, disagree, neither agree or disagree, agree, completely agree).
Intervention Appropriateness Measure (IAM)
Time frame: Within 2 weeks of intervention completion
Intervention Appropriateness will be assessed through a four-item measure (IAM). The measure includes four statements about the relevance or pertinence of the intervention (e.g. the intervention seems suitable; the intervention seems applicable; the intervention seems fitting; the intervention seems like a good match). Individuals rate the extent to which the agree with each statement on a five-level scale (completely disagree, disagree, neither agree or disagree, agree, completely agree).
Usefulness, Usability and Desirability Assessment (UUD)
Time frame: Within 2 weeks of intervention completion
The Usability of the remote delivery system (use of the iPad, Kubi robot; video upload) will be assessed with the UUD assessment. Usability includes three major components: usefulness, desirability, and usability. The UUD gathers data on usability (ease of use of the telehealth technology) (9 items), usefulness (value, relevance, and applicability of the telehealth technology) (10 items), and desirability (overall appeal or interest of the telehealth technology) (4 items). Items are rated a five-point Likert-type scale.
Fidelity of Intervention Assessment
Time frame: Once per week during 4-week intervention period
This instrument assesses the extent to which the therapist adhered to fifteen core constructs of the intervention protocol. Evidence of adherence to high quality pediatric rehabilitation elements includes 6 constructs that are scored as Present (present-some and present-strong) or Absent. Includes items such as "collaboration between parent and therapist" and "aligning therapy with child's goals". Evidence of core components of pediatric constraint induced movement therapy is scored as Present or Absent. Includes items such as "high intensity of intervention" and occurs in "natural environment". Total score is number of core components present.
2 secondary outcomes
Fidelity of Remote Assessment
Time frame: Within one week following the assessment
Perceptions of Remote Assessment and Intervention
Time frame: Within one week following the intervention.
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 19 Dec 2023.
- Derived from this study: PubMed 42221522Maus E, Rittler A, Amon K, Heathcock J, Lo W, DeLuca S, Darragh A. Exploring Parent Perspectives of Feasibility After Intensive Telerehabilitation for Children with Unilateral Cerebral Palsy: A Mixed Methods Study. J Dev Phys Disabil. 2026;38(3):543-562. doi: 10.1007/s10882-025-10033-9. Epub 2025 Sep 1.
- Individual participant dataSharing planned: No
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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.
Warren Lo principal investigator
Nationwide Children's Hospital
Amy Darragh principal investigator
Ohio State University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pediatric Constrained Induced Movement Therapy in people with Hemiplegic Cerebral Palsy, run by Ohio State University at 3 sites in United States.
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 3 inclusion and 2 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 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Feasibility of Intervention Measure (FIM) (time frame: Within 2 weeks of intervention completion). The study lists 5 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 NCT05303883, which also lists 1 linked publication.
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 19 Dec 2023.