Tele-Video CIMT for Cerebral Palsy

Recruiting at1 trial location

Overseen by Warren Lo, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Warren Lo

Must not be taking: Botulinum toxin

Disqualifiers: Previous high dose CIMT, Surgery, Medically unstable, Behaviorally impaired, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The CHAMP-T2 study is a pilot test of the efficacy of constraint induced movement therapy (CIMT) when delivered by tele-video in the child's home or home-like environment. This study will examine the pre-, post-intervention function a hemiparetic limb in children who have hemiplegic cerebral palsy. The purpose is to provide an effect size estimate that will inform the design of a future study that will compare tele-delivered CIMT with usual and customary care.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Constraint Induced Movement Therapy (CIMT) for children with cerebral palsy?

Research shows that Constraint-Induced Movement Therapy (CIMT) is effective for children with cerebral palsy, improving hand function and independence. Studies, including a systematic review and a multicenter trial, have demonstrated significant improvements in the use of the affected limb and overall motor skills. ^{1 2 3 4 5}

Is Constraint-Induced Movement Therapy (CIMT) safe for children with cerebral palsy?

Research on Constraint-Induced Movement Therapy (CIMT) for children with cerebral palsy suggests it is generally safe, though concerns about the potentially intrusive nature of restraining a child's unimpaired limb have been noted. Studies have shown that CIMT can be feasible and effective, with improvements in motor skills, but the approach should be gentle and adapted to individual needs. ^{5 6 7 8 9}

How is the treatment for cerebral palsy using Constraint Induced Movement Therapy (CIMT) unique?

Constraint Induced Movement Therapy (CIMT) is unique because it focuses on improving the use of the affected arm by restricting the use of the less-affected arm, encouraging children with cerebral palsy to use their weaker side more actively, which is different from other therapies that may not involve such targeted practice. ^{1 2 6 10 11}

Research Team

Warren Lo, MD

Principal Investigator

Nationwide Children's Hospital

Eligibility Criteria

This trial is for children with hemiplegic cerebral palsy, which affects one side of their body. They should be able to participate in therapy sessions via tele-video from home or a similar setting. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

My child, aged 5-10, has hemiplegic cerebral palsy with some hand use limitations and lives close to the specified locations.

Exclusion Criteria

I have undergone intensive therapy for 2 hours daily over 10 days.

My child cannot participate in the treatment due to behavioral or cognitive issues.

My child's caregiver at the treatment site cannot talk to the therapist.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Parents are trained in the principles of CIMT and use of tele-video equipment

2 days

2 visits (in-person) or virtual training

Treatment

Tele-delivered CIMT for 60 hours over 4 weeks, with daily sessions involving therapist and parent

4 weeks

5 sessions per week (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Constraint Induced Movement Therapy (Behavioural Intervention)

Trial Overview The CHAMP T2 study is testing the effectiveness of constraint induced movement therapy (CIMT) delivered through tele-video to improve the use of a limb affected by cerebral palsy.

Participant Groups

Group I: Intervention arm Experimental Treatment 1 Intervention

This is a single arm in an open label pre- post-treatment design to estimate effect size of the intervention

Who Is Running the Clinical Trial?

Warren Lo

Lead Sponsor

Trials

1

Recruited

10+

Virginia Polytechnic Institute and State University

Collaborator

Trials

162

Recruited

26,900+

Dr. Cyril Clarke

Virginia Polytechnic Institute and State University

Chief Medical Officer since 2018

DVM from University of Pretoria

Dr. Timothy Sands

Virginia Polytechnic Institute and State University

Chief Executive Officer since 2014

PhD in Materials Science from University of California, Berkeley

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Dr. John J. Warner

Ohio State University

Chief Executive Officer since 2023

MD, MBA

Dr. Peter Mohler

Ohio State University

Chief Medical Officer since 2023

PhD in Molecular Biology

Findings from Research

Group-based constraint-induced movement therapy (CIMT) for children with hemiplegic cerebral palsy showed significant improvements in motor skills after 4 weeks of therapy, with effects maintained at a 3-month follow-up.

The study involved 7 children participating in 2.5 hours of therapy per day, 5 days a week, indicating that this approach may be a feasible and effective alternative to individual therapy sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group constraint-induced movement therapy for children with hemiplegic cerebral palsy: a pilot study. Wu, WC., Hung, JW., Tseng, CY., et al.[2013]

A study involving 88 children with varying degrees of hemiparesis showed that high-intensity Constraint-Induced Movement Therapy (CIMT) led to significant improvements in motor function, as reported by parents and measured by standardized assessments.

The results indicate that the benefits of CIMT in clinical practice are comparable to those observed in rigorous clinical trials, suggesting that this therapy is effective across a diverse population of children with cerebral palsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practice-based evidence from a clinical cohort that received pediatric constraint- induced movement therapy. DeLuca, SC., Trucks, MR., Wallace, DA., et al.[2017]

Constraint-induced movement therapy (CIMT) has been shown to improve upper limb abilities in children with unilateral cerebral palsy, according to a consensus from experts and a comprehensive literature review.

There are significant knowledge gaps regarding the optimal dosage and frequency of CIMT, as well as how factors like age influence its effectiveness, highlighting the need for further research in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guidelines for future research in constraint-induced movement therapy for children with unilateral cerebral palsy: an expert consensus. Eliasson, AC., Krumlinde-Sundholm, L., Gordon, AM., et al.[2022]

In a study involving seven children aged 9-11 with hemiplegia, four participants showed significant improvements in upper limb function after two weeks of reduced intensity constraint-induced movement therapy (CIMT), indicating its potential efficacy for some children with cerebral palsy.

Qualitative feedback from participants highlighted challenges with the therapy's restraint, emphasizing the need for family involvement and better coordination with educational settings, suggesting that while CIMT can be beneficial, it may not be suitable for all children with hemiplegia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and acceptability of reduced intensity constraint-induced movement therapy for children aged 9-11 years with hemiplegic cerebral palsy: a pilot study. McConnell, K., Johnston, L., Kerr, C.[2014]

A pilot study involving five infants with unilateral cerebral palsy showed that Constraint-Induced Movement Therapy (CIMT) can lead to significant improvements in fine and gross motor skills during a one-month intervention period.

The study suggests that CIMT is feasible for infants, with improvements maintained at a one-month follow-up, although individual responses varied among participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study of the efficacy of constraint-induced movement therapy for infants and toddlers with cerebral palsy. Lowes, LP., Mayhan, M., Orr, T., et al.[2021]

Friendly-CIT, a modified version of constraint-induced therapy, was found to be feasible and effective in improving motor skills in children with cerebral palsy, as evidenced by significant improvements in various motor proficiency tests after 8 weeks of intervention with 15 participants.

The therapy also enhanced psychosocial outcomes, with children showing increased engagement and playfulness, while parents reported high satisfaction and no increase in stress, indicating a supportive approach to therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Efficacy of a Friendly Constraint-Induced Therapy (Friendly-CIT) Program on Motor and Psychosocial Outcomes in Children with Cerebral Palsy. Chen, YL., Chen, HL., Shieh, JY., et al.[2019]

In a study involving 42 children with hemiplegic cerebral palsy, both Constraint-Induced Movement Therapy (CIMT) and Hand-Arm Intensive Bimanual Therapy (HABIT) resulted in significant improvements in hand function, as measured by the Jebsen-Taylor Test and Assisting Hand Assessment, with benefits maintained for 6 months.

While both therapies were effective, HABIT showed greater progress towards self-determined goals, suggesting that bimanual training may offer additional advantages in achieving personalized functional outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bimanual training and constraint-induced movement therapy in children with hemiplegic cerebral palsy: a randomized trial. Gordon, AM., Hung, YC., Brandao, M., et al.[2022]

Constraint-induced movement therapy (CIMT) has shown significant effectiveness in improving upper extremity use in children with hemiplegic cerebral palsy, particularly in studies with rigorous designs, where large treatment effects were observed.

The review highlighted variability in study designs and outcomes, indicating a need for more standardized research methods to determine the optimal intensity and components of CIMT for different children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bound for success: a systematic review of constraint-induced movement therapy in children with cerebral palsy supports improved arm and hand use. Huang, HH., Fetters, L., Hale, J., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Constraint-induced movement therapy in the treatment of the upper limb in children with hemiplegic cerebral palsy: a Cochrane systematic review. [2018]

2. Iran pubmed.ncbi.nlm.nih.gov

The Effects of Constraint-Induced Movement Therapy on Functions of Cerebral Palsy Children. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Group constraint-induced movement therapy for children with hemiplegic cerebral palsy: a pilot study. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Multicenter randomized controlled trial of pediatric constraint-induced movement therapy: 6-month follow-up. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Practice-based evidence from a clinical cohort that received pediatric constraint- induced movement therapy. [2017]

6. England pubmed.ncbi.nlm.nih.gov

Guidelines for future research in constraint-induced movement therapy for children with unilateral cerebral palsy: an expert consensus. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Efficacy and acceptability of reduced intensity constraint-induced movement therapy for children aged 9-11 years with hemiplegic cerebral palsy: a pilot study. [2014]

8. England pubmed.ncbi.nlm.nih.gov

Pilot study of the efficacy of constraint-induced movement therapy for infants and toddlers with cerebral palsy. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Preliminary Efficacy of a Friendly Constraint-Induced Therapy (Friendly-CIT) Program on Motor and Psychosocial Outcomes in Children with Cerebral Palsy. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Bimanual training and constraint-induced movement therapy in children with hemiplegic cerebral palsy: a randomized trial. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Bound for success: a systematic review of constraint-induced movement therapy in children with cerebral palsy supports improved arm and hand use. [2018]