Remote Ischemic Conditioning for Cerebral Palsy

Overseen by Swati Surkar

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: East Carolina University

Must not be taking: Anti-seizure medications

Disqualifiers: Autism, Seizures, Cardiorespiratory dysfunctions, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a new treatment for children with one-sided cerebral palsy. It uses a blood pressure cuff to stop and start blood flow, combined with hand exercises, to help the brain learn new movements better. The goal is to improve hand and arm function in these children.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but children on anti-seizure medications are excluded from participating.

What data supports the effectiveness of the treatment Remote Ischemic Conditioning for Cerebral Palsy?

Research shows that Hand-Arm Bimanual Intensive Therapy (HABIT) improves hand function in children with cerebral palsy, and when combined with lower extremity activities (HABIT-ILE), it enhances both upper and lower limb functions. This suggests that intensive bimanual training, a component of the treatment, is effective in improving motor skills in children with cerebral palsy. ^{1 2 3 4 5}

Is Hand-Arm Bimanual Intensive Therapy (HABIT) safe for children with cerebral palsy?

The studies reviewed do not report any safety concerns related to Hand-Arm Bimanual Intensive Therapy (HABIT) for children with cerebral palsy, suggesting it is generally safe for this population. ^{1 2 3 6 7}

How is the treatment Bimanual Cup Stacking Training, Hand Arm Bimanual Intensive Therapy (HABIT) different from other treatments for cerebral palsy?

This treatment is unique because it focuses on improving the use of both hands together through intensive practice, which is different from other therapies that might focus on just one hand. It is designed to be child-friendly and involves structured activities that help improve coordination and independence in daily tasks. ^{1 8 9 10 11}

Research Team

Swati Surkar

Principal Investigator

East Carolina University

Eligibility Criteria

This trial is for children aged 6-16 with unilateral cerebral palsy, who can stack cups and follow instructions. They should be fairly independent in daily tasks (MACS levels I-III) and not have other developmental disabilities, seizures, metal implants, or be on certain medications.

Inclusion Criteria

I can use my hands for daily tasks with little to some help.

I am in regular school classes and can understand experiment instructions.

My child, aged 6-16, has been diagnosed with unilateral cerebral palsy.

Exclusion Criteria

Children with other conditions like autism or developmental coordination disorders.

My child has metal implants or devices not safe for MRI.

My child cannot voluntarily move muscles.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Remote Ischemic Conditioning (RIC) and intensive bimanual skill training, including Hand Arm Bimanual Intensive Therapy (HABIT) and bimanual cup stacking training

1 week

5 visits (in-person)

Follow-up

Participants are monitored for changes in bimanual skill performance, corticospinal excitability, and other functional outcomes

1 week

Treatment Details

Interventions

• Balance training (Behavioral Intervention)
• Bimanual Cup Stacking Training (Behavioral Intervention)
• Hand Arm Bimanual Intensive Therapy (HABIT) (Behavioral Intervention)
• Remote Ischemic Conditioning (RIC) (Corticosteroid)
• Sham conditioning (Behavioral Intervention)

Trial Overview The study tests if remote ischemic conditioning (RIC), a new method that temporarily restricts blood flow to limbs, can improve hand coordination when combined with intensive bimanual skill training in children with unilateral cerebral palsy.

Participant Groups

Group I: Remote Ischemic Conditioning (RIC) Experimental Treatment 4 Interventions

RIC is achieved via blood pressure cuff inflation to at least 20 mmHg above systolic blood pressure to 250 mmHg on the more involved arm. RIC involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation and requires 45 minutes. RIC is performed on visits 2-6. Intervention * Hand Arm Bimanual Intensive Therapy (HABIT) * Bimanual cup stacking training * Balance training

Group II: Sham Conditioning Placebo Group 4 Interventions

Sham conditioning is achieved via blood pressure cuff inflation to 25 mmHg on the more involved arm. RIC involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation and requires 45 minutes. RIC is performed on visits 2-6. Intervention * Hand Arm Bimanual Intensive Therapy (HABIT) * Bimanual cup stacking training * Balance training

Who Is Running the Clinical Trial?

East Carolina University

Lead Sponsor

Trials

111

Recruited

42,400+

Dr. Philip Rogers

East Carolina University

Chief Executive Officer since 2021

PhD in Business Administration from the University of South Carolina

Dr. Lee A. Fleisher

East Carolina University

Chief Medical Officer since 2023

MD from Brody School of Medicine, East Carolina University

Findings from Research

HABIT-ILE (Hand Arm Bimanual Intensive Therapy Including Lower Extremities) is a new therapy designed for children with unilateral spastic cerebral palsy, focusing on tasks that require coordination of both upper and lower extremities, which may better address their motor control challenges.

This therapy involves 90 hours of structured practice in small groups, progressively increasing task complexity, but further research through randomized controlled trials is necessary to evaluate its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hand-arm bimanual intensive therapy including lower extremities (HABIT-ILE) for children with cerebral palsy. Bleyenheuft, Y., Gordon, AM.[2014]

A study involving 86 children with unilateral spastic cerebral palsy showed that both Hand-Arm Bimanual Intensive Therapy (HABIT) and the new HABIT-ILE, which includes lower extremity engagement, led to significant improvements in upper extremity function without diminishing the benefits of the therapy.

HABIT-ILE resulted in larger functional improvements in daily living activities that require coordination between the upper and lower extremities, suggesting that incorporating lower extremity practice can enhance overall therapy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Including a Lower-Extremity Component during Hand-Arm Bimanual Intensive Training does not Attenuate Improvements of the Upper Extremities: A Retrospective Study of Randomized Trials. Saussez, G., Brandão, MB., Gordon, AM., et al.[2020]

Hand-Arm Bimanual Intensive Therapy (HABIT) significantly improved daily functioning and unimanual dexterity in children with bilateral cerebral palsy, as shown by assessments like the Pediatric Evaluation of Disability Inventory and the Box and Blocks Test, after a 90-hour intervention with 41 participants aged 4 to 16 years.

Despite the improvements in daily functioning and dexterity of the dominant hand, HABIT did not lead to significant changes in bimanual performance or the dexterity of the non-dominant hand, indicating that while HABIT is beneficial, it may not enhance all aspects of motor function equally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hand-arm bimanual intensive therapy and daily functioning of children with bilateral cerebral palsy: a randomized controlled trial. Figueiredo, PRP., Mancini, MC., Feitosa, AM., et al.[2021]

In a study involving 12 children aged 1.5 to 7 years with congenital hemiplegic cerebral palsy, both modified constraint-induced movement therapy (CIMT) and hand-arm bimanual intensive therapy (HABIT) showed significant improvements in upper extremity skills after 8 weeks of therapy (p < .001).

The improvements in bimanual skills and movement patterns were maintained for at least 6 months after the intervention, indicating the long-term efficacy of both therapies in a school-based setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of constraint-induced movement therapy and bimanual training in children with hemiplegic cerebral palsy in an educational setting. Gelkop, N., Burshtein, DG., Lahav, A., et al.[2015]

In a study involving 28 children with unilateral cerebral palsy, a 60-hour magic-themed hand-arm bimanual intensive therapy (HABIT) led to significant improvements in everyday task performance and unimanual hand skills, as measured by various assessments.

Parents reported enhanced bimanual hand use in daily activities, indicating that the therapy not only improved children's skills but also positively impacted their ability to perform tasks at home and in school.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upper Limb Function of Children with Unilateral Cerebral Palsy After a Magic-Themed HABIT: A Pre-Post-Study with 3- and 6-Month Follow-Up. Hines, A., Bundy, AC., Black, D., et al.[2020]

Both 90 hours and 45 hours of hand-arm bimanual intensive training (HABIT) led to significant improvements in hand function and daily activities in children with unilateral cerebral palsy, indicating that both training durations are effective.

While both groups showed benefits, more children in the 90-hour group achieved clinically meaningful improvements in hand function, suggesting that a longer training duration may be more beneficial, although the second 45-hour training session did not provide additional gains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Dosage Matter? A Pilot Study of Hand-Arm Bimanual Intensive Training (HABIT) Dose and Dosing Schedule in Children with Unilateral Cerebral Palsy. Brandão, MB., Mancini, MC., Ferre, CL., et al.[2018]

A meta-analysis of 4 high-quality randomized controlled trials involving children with unilateral spastic cerebral palsy found that Hand-arm bimanual intensive therapy (HABIT) offers only a trivial benefit in improving hand function compared to other therapies.

The overall effect size of HABIT was measured at 0.06, indicating minimal effectiveness, and the study suggests that more rigorous research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Hand-Arm Bimanual Intensive Therapy on Hand Function among Children with Unilateral Spastic Cerebral Palsy: A Meta-Analysis. Alahmari, K., Tedla, JS., Sangadala, DR., et al.[2020]

The home-based hybrid therapy combining Bimanual-Intensive-Therapy and modified Constraint-Induced-Movement-Therapy (h-BITmCI) was feasible and well-received by families, with all 10 participating children completing the program without dropouts.

Significant improvements in bimanual functional performance and quality of life were observed, particularly during the last 20 hours of modified therapy, indicating that the combination of therapies effectively enhances upper limb functionality in children with spastic unilateral cerebral palsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of family-directed home-based bimanual intensive therapy combined with modified constraint induced movement therapy (h-BITmCI) in very low and low bimanual functional level: A brief report. Palomo-Carrión, R., Romay-Barrero, H., Lirio-Romero, C., et al.[2023]

Intensive upper extremity training methods, such as constraint-induced movement therapy (CIMT) and bimanual training, have been shown to significantly improve hand dexterity and coordination in children with unilateral cerebral palsy, based on studies involving over 100 participants since 1997.

The effectiveness of these therapies is highly dependent on the dosage, with 90 hours of training leading to better outcomes than 60 hours, and older children may require even more frequent and intensive sessions for optimal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

To constrain or not to constrain, and other stories of intensive upper extremity training for children with unilateral cerebral palsy. Gordon, AM.[2011]

Constraint-induced (CI) movement therapy has shown promise in improving unimanual hand function in children with hemiplegic cerebral palsy, but it does not adequately address bimanual coordination impairments that are also present in these children.

A new intervention called hand-arm bimanual intensive training (HABIT) aims to improve bimanual coordination without the use of physical restraints, retaining the child-friendly and intensive practice elements of CI therapy, although its efficacy still needs to be evaluated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of hand-arm bimanual intensive training (HABIT) for improving bimanual coordination in children with hemiplegic cerebral palsy. Charles, J., Gordon, AM.[2022]

A study involving 24 children with unilateral spastic cerebral palsy showed that the Hand and Arm Bimanual Intensive Therapy Including Lower Extremity (HABIT-ILE) significantly improved hand function and locomotor abilities compared to conventional therapies.

The intensive training protocol was effective in enhancing both upper and lower extremity functions, as evidenced by significant improvements in primary outcomes like the Assisting Hand Assessment and the Six-Minute Walk Test.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hand and Arm Bimanual Intensive Therapy Including Lower Extremity (HABIT-ILE) in Children With Unilateral Spastic Cerebral Palsy: A Randomized Trial. Bleyenheuft, Y., Arnould, C., Brandao, MB., et al.[2022]

References

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

Hand-arm bimanual intensive therapy including lower extremities (HABIT-ILE) for children with cerebral palsy. [2014]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Including a Lower-Extremity Component during Hand-Arm Bimanual Intensive Training does not Attenuate Improvements of the Upper Extremities: A Retrospective Study of Randomized Trials. [2020]

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

Hand-arm bimanual intensive therapy and daily functioning of children with bilateral cerebral palsy: a randomized controlled trial. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Efficacy of constraint-induced movement therapy and bimanual training in children with hemiplegic cerebral palsy in an educational setting. [2015]

5. England pubmed.ncbi.nlm.nih.gov

Upper Limb Function of Children with Unilateral Cerebral Palsy After a Magic-Themed HABIT: A Pre-Post-Study with 3- and 6-Month Follow-Up. [2020]

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

Does Dosage Matter? A Pilot Study of Hand-Arm Bimanual Intensive Training (HABIT) Dose and Dosing Schedule in Children with Unilateral Cerebral Palsy. [2018]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of Hand-Arm Bimanual Intensive Therapy on Hand Function among Children with Unilateral Spastic Cerebral Palsy: A Meta-Analysis. [2020]

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

Feasibility of family-directed home-based bimanual intensive therapy combined with modified constraint induced movement therapy (h-BITmCI) in very low and low bimanual functional level: A brief report. [2023]

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

To constrain or not to constrain, and other stories of intensive upper extremity training for children with unilateral cerebral palsy. [2011]

10. England pubmed.ncbi.nlm.nih.gov

Development of hand-arm bimanual intensive training (HABIT) for improving bimanual coordination in children with hemiplegic cerebral palsy. [2022]

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

Hand and Arm Bimanual Intensive Therapy Including Lower Extremity (HABIT-ILE) in Children With Unilateral Spastic Cerebral Palsy: A Randomized Trial. [2022]