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

46 Participants Needed

Trial Summary

What is the purpose of this trial?

Unilateral cerebral palsy (UCP) is a leading cause of childhood disability. An early brain injury impairs the upper extremity function, bimanual coordination, and impacts the child's independence. The existing therapeutic interventions have higher training doses and modest effect sizes. Thus, there is a critical need to find an effective priming agent to enhance bimanual skill learning in children with UCP. This study aims to determine the effects of a novel priming agent, remote ischemic conditioning (RIC), when paired with bimanual skill training to enhance bimanual skill learning and to augment skill dependent plasticity in 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 data supports the effectiveness of the treatment Bimanual Cup Stacking Training for Cerebral Palsy?

Research shows that intensive bimanual training, like the Hand-Arm Bimanual Intensive Therapy (HABIT), improves hand function and daily activities in children with cerebral palsy. Studies also suggest that combining bimanual training with other therapies can enhance motor skills and functional independence. ^{1 2 3 4 5}

Is bimanual skill training safe for children with cerebral palsy?

Bimanual skill training, including intensive bimanual training, has been studied in children with cerebral palsy and is generally considered safe. Some parents reported stress due to the training's intensity, but no significant safety concerns were noted in the studies. ^{1 2 3 6 7}

How is Bimanual Cup Stacking Training different from other treatments for cerebral palsy?

Bimanual Cup Stacking Training is unique because it focuses on improving coordination and motor skills by using both hands together in a fun, goal-oriented activity, which can be more engaging for children. Unlike some other therapies, it emphasizes direct practice of meaningful tasks, potentially leading to better skill transfer and coordination improvements. ^{1 2 3 6 8}

Eligibility Criteria

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.

Mainstream in school

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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 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]

References

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

Bimanual Skill Learning after Transcranial Direct Current Stimulation in Children with Unilateral Cerebral Palsy: A Brief Report. [2020]

2. 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]

3. 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]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Combining Unimanual and Bimanual Therapies for Children with Hemiparesis: Is There an Optimal Delivery Schedule? [2023]

5. 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]

6. England 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. [2018]

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

Effect of Home-based Bimanual Training in Children with Unilateral Cerebral Palsy (The COAD-study): A Case Series. [2021]

8. England 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? [2017]