Telemedicine-Based Constraint Therapy for Cerebral Palsy

(APPLES-TELE Trial)

Recruiting at3 trial locations

Overseen by Nathalie Maitre, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Emory University

Must not be taking: Botulinum toxin

Disqualifiers: Congenital malformation, Prior constraint programs, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests two therapies for infants with cerebral palsy: one delivered via telehealth and one focused on parent-led activities at home. Both aim to improve hand and arm function by involving parents in consistent exercises.

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.

What data supports the effectiveness of the treatment Telemedicine-Based Constraint Therapy for Cerebral Palsy?

Research shows that constraint-induced movement therapy (CIMT) and bimanual therapy are effective for children with cerebral palsy, helping improve their ability to use their hands and perform daily activities. These therapies involve intensive practice and are based on motor learning principles, which have been shown to lead to significant improvements in children's motor skills. ^{1 2 3 4 5}

Is telemedicine-based constraint therapy for cerebral palsy safe for humans?

Constraint-Induced Movement Therapy (CIMT), which is part of the telemedicine-based constraint therapy, has been studied in children with cerebral palsy and is generally considered safe. Parents have expressed concerns, but studies have documented both short- and long-term positive effects without significant safety issues. ^{1 2 4 6 7}

How is the Telemedicine-Based Constraint Therapy for Cerebral Palsy treatment different from other treatments?

This treatment is unique because it combines telemedicine (remote healthcare) with a parent-centered approach, allowing families to implement constraint-induced movement therapy (CIMT) and bimanual therapy at home, making it more accessible and feasible for families compared to traditional in-person therapies. ^{1 3 4 8 9}

Research Team

Nathalie Maitre, MD

Principal Investigator

Emory University

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

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

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.

Participant Groups

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.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Dr. R. Donald Harvey

Emory University

Chief Medical Officer

MD from Emory University School of Medicine

Dr. George Painter

Emory University

Chief Executive Officer since 2013

PhD in Synthetic Organic Chemistry from Emory University

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Dr. Diana W. Bianchi

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

Chief Executive Officer since 2016

MD from Stanford University

Dr. Alison Cernich

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

Chief Medical Officer since 2020

PhD in Clinical Psychology from University of Maryland

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

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

3. England pubmed.ncbi.nlm.nih.gov

Modified constraint-induced therapy for children with hemiplegic cerebral palsy: a randomized trial. [2015]

4. 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]

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

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

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

Modified constraint-induced movement therapy for a 12-month-old child with hemiplegia: a case report. [2019]

7. Iran pubmed.ncbi.nlm.nih.gov

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

8. United States 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. [2022]

9. United States 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. [2023]