Telemedicine-Based Constraint Therapy for Cerebral Palsy

(APPLES-TELE Trial)

Recruiting at 3 trial locations

Overseen By Nathalie Maitre, MD, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Must not be taking: Botulinum toxin

Disqualifiers: Congenital malformation, Prior constraint programs, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

267 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to assist infants with cerebral palsy (CP), a condition affecting movement and coordination. It tests two therapies in different sequences to assess their impact compared to usual care. One therapy is APPLES-tele, a telemedicine-based constraint therapy, and the other is a Parent-centered Approach (PCA) Support Intervention. Infants aged 4 to 13 months diagnosed with CP or at high risk for developing it may be suitable for this trial. The goal is to discover more effective ways to improve movement and quality of life for these infants through innovative treatments. As an unphased trial, this study provides a unique opportunity to investigate cutting-edge therapies that could significantly enhance the quality of life for infants with CP.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you have received botulinum toxin to the affected extremity within 3 months, you cannot participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that APPLES-tele, a therapy encouraging movement, is safe for children with cerebral palsy. Studies have found that this therapy improves arm and hand use without causing harm. Previous research with children who have cerebral palsy showed they handled this therapy well.

The Parent-centered Approach (PCA) Support Intervention involves family members in the child's care. This method is generally safe and focuses on supporting both the child and their family. Studies on similar family-focused care have received positive feedback from families, demonstrating safety and effectiveness.

Existing research has proven both treatments in the trial safe for children with cerebral palsy. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Telemedicine-Based Constraint Therapy for cerebral palsy because it offers a unique approach by integrating digital technology into rehabilitation. Unlike traditional therapies that require in-person visits, this method uses telemedicine, allowing patients to receive treatment from home. This is particularly beneficial for families who face logistical challenges in accessing regular therapy sessions. The Parent-centered Approach (PCA) Support Intervention also empowers caregivers by actively involving them in the therapeutic process, which can enhance the overall efficacy and sustainability of the treatment. This trial aims to explore how these innovative methods can improve the quality of life for patients with cerebral palsy.

What evidence suggests that this trial's treatments could be effective for cerebral palsy?

Research shows that Constraint-Induced Movement Therapy (CIMT), similar to APPLES-tele, greatly improves arm and hand use in children with cerebral palsy. Studies have found that CIMT excels in aiding tasks like grasping and using one hand compared to other therapies. Early results suggest that increased time spent on CIMT enhances the use of affected limbs. In this trial, some participants will first receive the APPLES-tele intervention, followed by the Parent-centered Approach (PCA) Support Intervention, while others will receive PCA first, followed by APPLES-tele.

For the PCA Support Intervention, research strongly supports family-centered care in enhancing the well-being of both children with cerebral palsy and their parents. This approach also increases caregivers' satisfaction with achieving goals for both the child and themselves. Overall, both APPLES-tele and PCA show promising evidence in improving important areas for children with cerebral palsy and their families. ^{5 6 7 8 9}

Who Is on the Research Team?

Nathalie Maitre, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for infants aged 4 to 13 months at risk of or diagnosed with cerebral palsy, who have been patients in certain clinics. They must show arm movement differences and haven't had long-term constraint programs, brain or musculoskeletal malformations, or recent botulinum toxin treatments.

Inclusion Criteria

Hand Assessment for Infants (HAI) difference between hands ≥2, with an observable and relative difference in quality or amount of movement between hands, as determined by HAI-certified study therapists and/or a unimanual Bayley score difference between hands >1

Parent/legal guardian is able to provide informed consent

I am diagnosed with or at high risk for cerebral palsy.

Exclusion Criteria

I was born with a brain or musculoskeletal system malformation.

I have not received botulinum toxin in my affected limb in the last 3 months.

Any prior long-term hard constraint programs

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1

Participants receive either the APPLES-tele intervention or the PCA intervention for 6 weeks

6 weeks

Telehealth sessions

Treatment Phase 2

Participants receive the alternate intervention (either PCA or APPLES-tele) for another 6 weeks

6 weeks

Telehealth sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• APPLES-tele
• Parent-centered Approach (PCA) Support Intervention
• Standard of Care

Trial Overview

The study compares two active treatments: APPLES-tele and PCA Support Intervention against standard care. Infants will receive these interventions in different sequences to see which is more effective for early childhood development.

How Is the Trial Designed?

Group I: PCA first, then APPLES-tele Experimental Treatment 3 Interventions

Participants receiving the PCA intervention for 6 weeks followed by the APPLES-tele intervention for 6 weeks.

Group II: APPLES-tele first, then PCA Experimental Treatment 3 Interventions

Participants receiving the APPLES-tele intervention for 6 weeks followed by the PCA intervention for 6 weeks.

Group III: Standard of Care Control Arm Active Control 1 Intervention

Participants receiving the standard of care for 6 weeks.

APPLES-tele is already approved in United States for the following indications:

Approved in United States as APPLES for:

• Cerebral Palsy
• Asymmetric Cerebral Palsy

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

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]

A telehealth intervention for infants with asymmetric cerebral palsy showed promising results, with a significant improvement in fine motor functioning of the more affected upper extremity, indicated by a large effect size (Cohen d = 0.92) after treatment.

The intervention demonstrated high treatment fidelity among parents, with an average adherence rate of 95.7%, suggesting that the telehealth model is feasible for delivering this type of therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol and Feasibility-Randomized Trial of Telehealth Delivery for a Multicomponent Upper Extremity Intervention in Infants With Asymmetric Cerebral Palsy. Pietruszewski, L., Burkhardt, S., Yoder, PJ., et al.[2022]

In a study involving 48 children with unilateral cerebral palsy, both constraint-induced movement therapy (CIMT) and bimanual intensive training (BIT) showed similar motor improvements, but CIMT led to greater enhancements in the use of the affected hand at the 6-month follow-up.

The study highlights the importance of considering both motor and psychosocial outcomes in rehabilitation, suggesting that CIMT may be more easily implemented by parents due to its core principle of encouraging use of the affected hand.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Constraint-Induced Movement Therapy Versus Bimanual Intensive Training on Motor and Psychosocial Outcomes in Children With Unilateral Cerebral Palsy: A Randomized Trial. Liang, KJ., Chen, HL., Huang, CW., et al.[2023]

A multisite randomized controlled trial involving 18 children with unilateral cerebral palsy found that both 3 hours and 6 hours of constraint-induced movement therapy (CIMT) per day for 21 days led to significant improvements in upper extremity function, maintained at 6 months post-treatment.

The study showed no significant difference in the maintenance of gains between the two dosage groups, indicating that both treatment durations were effective in enhancing motor skills without a clear advantage for the longer duration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter randomized controlled trial of pediatric constraint-induced movement therapy: 6-month follow-up. Case-Smith, J., DeLuca, SC., Stevenson, R., et al.[2019]

Constraint-Induced Movement Therapy (CIMT) has been shown to effectively improve hand function in children with hemiplegic cerebral palsy, enhancing their independence.

This systematic review included 15 relevant studies, indicating that while CIMT is beneficial compared to no intervention, there are inconsistencies in its effectiveness regarding muscle tone and protective extension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Constraint-Induced Movement Therapy on Functions of Cerebral Palsy Children. Jamali, AR., Amini, M.[2022]

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]

Constraint-induced movement therapy (CIMT) is effective for improving unimanual skills in children with unilateral cerebral palsy, but it primarily supports implicit learning and may not adequately address the explicit learning needed for bimanual tasks.

Bimanual therapy complements CIMT by focusing on the use of both hands together, helping children recognize when to use two hands for tasks, thus enhancing their overall motor skills development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unimanual versus bimanual therapy in children with unilateral cerebral palsy: Same, same, but different. Hoare, B., Greaves, S.[2017]

In a study involving 50 children with hemiplegic cerebral palsy, modified constraint-induced therapy did not show significant improvements in daily living activities or upper limb function compared to intensive occupational therapy, indicating similar efficacy between the two approaches.

Minor adverse events were reported more frequently in the modified constraint-induced therapy group, suggesting that while both therapies are generally safe, acceptance of the therapy may affect participant experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modified constraint-induced therapy for children with hemiplegic cerebral palsy: a randomized trial. Wallen, M., Ziviani, J., Naylor, O., et al.[2015]

Modified constraint-induced movement therapy (CIMT) was effective in improving upper-limb function in a 12-month-old child with right hemiplegia, with benefits sustained for at least 6 months after treatment.

The therapy involved a nonremovable cast on the unaffected arm and intensive therapy sessions, and importantly, no adverse events related to the cast were reported, indicating the safety of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modified constraint-induced movement therapy for a 12-month-old child with hemiplegia: a case report. Cope, SM., Forst, HC., Bibis, D., et al.[2019]

Citations

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APPLES

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Telemedicine-Based Constraint Therapy for Cerebral Palsy

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