Bimanual Skill Training for Cerebral Palsy

(RIC Trial)

Overseen By Swati Surkar, PT, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: East Carolina University

Must not be taking: Anti-seizure medications

Disqualifiers: Autism, ADHD, Cardiorespiratory disorders, others

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

Compensation: Varies

Number of Visits: 7

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help children with unilateral cerebral palsy (UCP) improve hand coordination and independence. Researchers are testing remote ischemic conditioning (RIC), which uses a blood pressure cuff on the arm, combined with bimanual cup stacking training (a form of bimanual occupational therapy). The goal is to determine if RIC can enhance the effectiveness of bimanual skill training by boosting brain plasticity (the brain's ability to change and adapt). Children with UCP who can stack three cups in one minute and attend mainstream schools might be eligible. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance therapeutic options for children with UCP.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on anti-seizure medications, you may not be eligible to participate.

What prior data suggests that this protocol is safe for children with unilateral cerebral palsy?

Research has shown that remote ischemic conditioning (RIC) is safe and well-tolerated for children with unilateral cerebral palsy (UCP). RIC involves inflating a blood pressure cuff on the arm, and studies have found it does not harm the skin or cause serious side effects. Most children experienced only mild discomfort, with average pain scores of about 2.8 out of 10 when the cuff was inflated. Importantly, these studies reported no serious adverse events. This suggests that RIC is a promising and safe method to help children with UCP improve their skills. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the innovative approach of bimanual skill training for cerebral palsy because it focuses on improving hand coordination through a fun and engaging activity—cup stacking. Unlike traditional therapies that often rely on repetitive exercises or medications, this method emphasizes real-world skill application, which could lead to better functional improvements. Additionally, the trial involves Remote Ischemic Conditioning (RIC), a technique that uses controlled blood pressure cuff inflation to potentially enhance neural plasticity and muscle function. This combination of playful skill-building and cutting-edge conditioning could offer new hope for individuals with cerebral palsy by improving their motor skills more effectively than current options.

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

Research has shown that remote ischemic conditioning (RIC), a treatment in this trial, can improve outcomes for neurological conditions. One study found that 62.7% of patients who received RIC achieved excellent results, compared to 56.8% in the group without RIC. Other findings suggest that RIC can enhance brain function. In children with one-sided cerebral palsy, studies indicate that RIC combined with training may improve the ability to use both hands together. Overall, this evidence supports RIC's potential to enhance skill learning in children with one-sided cerebral palsy. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for children with unilateral cerebral palsy who are mainstreamed in school, can stack 3 cups in a minute, and have certain levels of manual ability. It's not for kids who've had seizures recently, take anti-seizure meds, have other developmental issues or serious health problems like heart disease or cancer.

Inclusion Criteria

I can stack 3 cups in under a minute.

My child has been diagnosed with cerebral palsy affecting one side.

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

Exclusion Criteria

Children with known cardiorespiratory, vascular, and metabolic disorders

Children with other developmental disabilities such as autism, attention deficit hyperactivity disorder, developmental coordination disorders, etc.

My child has a tumor and water on the brain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Remote Ischemic Conditioning (RIC) or Sham conditioning combined with bimanual task training

1 week

7 visits (in-person)

Follow-up

Participants are monitored for changes in motor thresholds and bimanual coordination post-intervention

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Bimanual Cup Stacking Training

Trial Overview The study tests if remote ischemic conditioning (RIC) can improve learning bimanual skills—like cup stacking—in kids with unilateral cerebral palsy. RIC is paired with skill training to see if it helps the brain adapt better than training alone.

How Is the Trial Designed?

Group I: Remote Ischemic Conditioning (RIC) Experimental Treatment 1 Intervention

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 1-7.

Group II: Sham conditioning Placebo Group 1 Intervention

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 1-7.

Who Is Running the Clinical Trial?

East Carolina University

Lead Sponsor

Trials

111

Recruited

42,400+

Published Research Related to This Trial

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]

In a study involving 34 children with unilateral cerebral palsy, an intensive 2-week program combining modified constraint and bimanual training led to significant improvements in arm functioning, as measured by the Assisting Hand Assessment (AHA).

While all children showed similar trends in bimanual abilities, only those classified as MACS level III demonstrated significant improvements in unilateral hand function on their less-affected side, indicating that the level of manual ability influences the effectiveness of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Influence of Intense Combined Training on Upper Extremity Function in Children With Unilateral Cerebral Palsy: Does Initial Ability Matter? Cohen-Holzer, M., Sorek, G., Kerem, J., et al.[2017]

In a study involving 17 children with unilateral cerebral palsy, both bimanual training with constraint (Hybrid) and bimanual training without constraint showed significant improvements in manual function after 2 weeks of intensive therapy.

The Hybrid program specifically improved function in the affected hand, while the Bimanual program improved function in the less-affected hand, suggesting that both methods have unique benefits that should be explored further.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Bimanual Training with or Without Constraint on Hand Functions in Children with Unilateral Cerebral Palsy: A Non-Randomized Clinical Trial. Cohen-Holzer, M., Katz-Leurer, M., Meyer, S., et al.[2018]

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]

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 eight children with unilateral cerebral palsy, a combined intervention of bimanual therapy and transcranial direct current stimulation (tDCS) over 10 days led to significant improvements in a novel bimanual skill task, indicating enhanced motor learning.

The results showed that task performance improved during the intervention, with decreased variability in task execution for 6 out of 8 participants, suggesting that this rehabilitation approach may effectively support skill learning in children with UCP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bimanual Skill Learning after Transcranial Direct Current Stimulation in Children with Unilateral Cerebral Palsy: A Brief Report. Nemanich, ST., Rich, TL., Gordon, AM., et al.[2020]

In a study involving 14 children with unilateral cerebral palsy, home-based bimanual training led to significant improvements in bimanual skills, with 86% of children showing clinically relevant progress by the end of the 12-week program.

While the training was effective, some parents reported increased stress due to the intensity of the program, highlighting the need for support in managing training demands.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Home-based Bimanual Training in Children with Unilateral Cerebral Palsy (The COAD-study): A Case Series. Beckers, L., Rameckers, E., Aarts, P., et al.[2021]

In a study involving 35 children with unilateral cerebral palsy, both modified Constraint-Induced Movement Therapy (mCIMT) and bimanual therapy (BT) were effective in improving hand function and functional independence over a 6-week intensive program.

The order in which mCIMT and BT were delivered did not significantly affect the outcomes, as all groups showed similar improvements in hand function and satisfaction, indicating that both therapies can be effectively combined regardless of the schedule.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining Unimanual and Bimanual Therapies for Children with Hemiparesis: Is There an Optimal Delivery Schedule? Au, KLK., Knitter, JL., Morrow-McGinty, S., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12564897/

Feasibility, Safety, and Tolerability of Remote Ischemic ... Remote ischemic conditioning (RIC) was feasible in children with unilateral cerebral palsy (CP), with excellent recruitment, retention, and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05777070

Effects of Remote Ischemic Conditioning on Bimanual Skill ... Investigators hypothesize that compared to sham conditioning + training, RIC + training will significantly enhance: 1) bimanual skill performance (decrease in ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41153554/

Feasibility, Safety, and Tolerability of Remote Ischemic ... Repeated RIC is feasible, safe, and tolerable in children with unilateral CP. These findings support the design of future trials using RIC ...

4. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.124.048509

Safety and Efficacy of Remote Ischemic Conditioning in ... At 90 days, 62.7% of patients in the RIC group and 56.8% in the sham RIC group had an excellent functional outcome (unadjusted risk ratio, 1.10 ...

5. systematicreviewsjournal.biomedcentral.com systematicreviewsjournal.biomedcentral.com/articles/10.1186/s13643-024-02725-8

Remote ischaemic conditioning for neurological disorders—a ... The results show significantly shorter latency and larger magnitudes in the RIC group. The study also showed significant improvement in cerebral ...

6. researchgate.net researchgate.net/publication/396443812_Feasibility_Safety_and_Tolerability_of_Remote_Ischemic_Conditioning_in_Children_with_Unilateral_Cerebral_Palsy_A_Randomized_Controlled_Trial

Feasibility, Safety, and Tolerability of Remote Ischemic ... RIC was well tolerated, with mean pain scores 2.8 ± 3.1 during inflation in RIC and 0.3 ± 0.8 in Sham group. No serious adverse events occurred.