Intensive Bimanual Therapy for Cerebral Palsy

Overseen By Catherine Mercier, PhD;OT

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Laval University

Must not be taking: Botox

Disqualifiers: Significant health problems, Visual deficits, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 2 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how intensive bimanual therapy can improve arm movement in children and youth with cerebral palsy. The therapy includes engaging games and exercises that encourage spontaneous use of the more affected arm in daily activities. Researchers aim to assess the therapy's impact on both single-arm and two-arm motor functions and will examine brain imaging results to predict outcomes. Ideal participants have cerebral palsy with noticeable sensorimotor difficulties in one or both arms and can understand and perform the study tasks. As an unphased trial, this study offers a unique opportunity for participants to contribute to groundbreaking research that could enhance therapeutic approaches for cerebral palsy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have had a Botox injection in the last 4 months, you cannot participate.

What prior data suggests that this intensive bimanual therapy is safe for children and youth with cerebral palsy?

Research has shown that intensive bimanual therapy is generally safe for children with cerebral palsy. Studies have found that this therapy improves hand function and coordination. No reports of serious side effects have emerged. The exercises are designed to be fun and engaging, helping participants enhance their motor skills. Overall, the therapy is well-tolerated, with no significant negative effects reported in the studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for cerebral palsy, which often involve physical therapy focusing on general motor skills or medication to manage symptoms, intensive bimanual therapy zeroes in on improving the use of the more affected hand by engaging both hands simultaneously. Researchers are excited about this approach because it emphasizes playful, game-based exercises that can make therapy more engaging for kids and may promote spontaneous use of the affected hand. This method could offer a more targeted and enjoyable alternative, potentially leading to better functional outcomes and greater independence for children and youth living with cerebral palsy.

What evidence suggests that intensive bimanual therapy is effective for cerebral palsy?

Studies have shown that intensive bimanual therapy, which participants in this trial will receive, can enhance the ability to use both hands together and increase the skill of one hand. Research indicates that this therapy also improves self-care abilities and helps achieve personal goals, leading to greater satisfaction. For children with unilateral spastic cerebral palsy, where one side of the body is more affected, more intensive training results in better hand function than less intensive options. Additionally, intensive bimanual therapy has improved hand use and movement, though it does not significantly affect large movements like walking. These findings suggest that the therapy could enhance the use of the more affected arm in daily life. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for children with cerebral palsy who can understand and perform study tasks, have sensorimotor deficits in one or both arms (with a preference on one side), and are classified as MACS level 1 to 3. It's not for those with uncorrected vision issues, other major health problems that could interfere, or recent Botox injections in the arms.

Inclusion Criteria

I have been diagnosed with cerebral palsy or spastic hemiparesis.

I have movement difficulties in one or both of my arms.

I can understand and follow the study's tasks.

Exclusion Criteria

Presenting significant uncorrected visual deficits

I do not have any major health issues that could affect my participation.

I have had a Botox injection in my arm(s) within the last 4 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-intervention Evaluation

Neuroimaging assessment, clinical evaluation, robotic evaluation, and movement evaluation using inertial control units

1 week

Treatment

Participants undergo a 60-hour intensive bimanual therapy at a day camp, 6 hours/day for 10 days

2 weeks

10 visits (in-person)

Post-intervention Evaluation

Clinical and robotic evaluations, including Jebsen Taylor Test of Hand Function and self-assessments

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment, including neuroimaging and various clinical evaluations

6 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Intensive bimanual therapy

Trial Overview The trial studies intensive bimanual therapy's effect on arm movement and everyday use of the most affected arm in kids with cerebral palsy. It also looks at how brain imaging might predict outcomes from this therapy.

How Is the Trial Designed?

Group I: MANUS Experimental Treatment 1 Intervention

Children and youth living with cerebral palsy will take part in a 60-hour intensive bimanual therapy at Peps at Université Laval, during which they will play games and exercise to promote spontaneous use of the most affected hand. Participants will take part to pre-evaluation and 1-week and 6-month post-intervention.

Intensive bimanual therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Intensive Bimanual Therapy for:

• Cerebral Palsy
• Upper Limb Motor Deficits

Approved in European Union as Hand-Arm Bimanual Intensive Therapy (HABIT) for:

• Cerebral Palsy
• Bilateral Cerebral Palsy
• Upper Limb Motor Deficits

Approved in Canada as Bimanual Therapy for:

• Cerebral Palsy
• Upper Limb Motor Deficits

Who Is Running the Clinical Trial?

Laval University

Lead Sponsor

Trials

439

Recruited

178,000+

Published Research Related to This Trial

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]

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]

A systematic review of 8 studies involving 221 children with unilateral cerebral palsy found that both intensive bimanual therapy (IBT) and modified constraint-induced movement therapy (mCIMT) can improve upper limb function, but neither approach was definitively superior.

IBT received a weak recommendation for enhancing movement quality and parent-reported performance, suggesting it may be more beneficial in certain aspects of motor function compared to mCIMT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing Unimanual and Bimanual Training in Upper Extremity Function in Children With Unilateral Cerebral Palsy. Klepper, SE., Clayton Krasinski, D., Gilb, MC., et al.[2018]

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]

A study involving 20 children with bilateral cerebral palsy showed that hand-arm bimanual intensive therapy including lower extremity (HABIT-ILE) significantly improved both upper and lower extremity functions after 84 hours of intervention over 13 days.

The improvements were measured using various assessments, including the Gross Motor Function Measure (GMFM-66) and showed lasting effects even at a 3-month follow-up, indicating the therapy's efficacy for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensive upper- and lower-extremity training for children with bilateral cerebral palsy: a quasi-randomized trial. Bleyenheuft, Y., Ebner-Karestinos, D., Surana, B., et al.[2017]

The study will evaluate the effectiveness of the Preschool Hand Arm Bimanual Intensive Training Including Lower Extremity (HABIT-ILE) intervention in improving motor skills in 60 children aged 2-5 years with bilateral cerebral palsy, comparing it to usual care over a 10-day period.

Primary outcomes will focus on gross and fine motor skills using the Peabody Developmental Motor Scales, with additional assessments on various aspects of function and quality of life, ensuring a comprehensive evaluation of the intervention's impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preschool HABIT-ILE: study protocol for a randomised controlled trial to determine efficacy of intensive rehabilitation compared with usual care to improve motor skills of children, aged 2-5 years, with bilateral cerebral palsy. Sakzewski, L., Reedman, S., McLeod, K., et al.[2021]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11877199/

Effectiveness of hand-arm bimanual intensive therapy ... This therapy results in improvements in bimanual ability, unilateral dexterity, self-care function, functional goal performance and satisfaction ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2826288

Hand-Arm Bimanual Intensive Therapy Including Lower ... This randomized clinical trial investigates the effectiveness of bimanual intensive therapy including lower extremities in improving motor ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25527487/

Hand and Arm Bimanual Intensive Therapy Including ... Intensive bimanual training results in more improvement in hand function in children with unilateral spastic cerebral palsy (USCP) than lower intensity ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0022347625002069

A Multisite Randomized Controlled Trial of Hand Arm ... HABIT-ILE was effective in improving manual ability, mobility, self-care, and goal performance, but not gross motor function. Significant gains were immediately ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07134894

Intensive Bimanual Therapy Versus Conventional Physical ... This trial is designed to provide evidence on whether the integration of IBT into standard therapy protocols can optimize functional upper limb ...

6. physio-pedia.com physio-pedia.com/Hand-Arm_Bimanual_Intensive_Training_Including_Lower_Extremities_(HABIT-ILE)

Hand-Arm Bimanual Intensive Training Including Lower ... Several studies have employed a range of outcome measures to evaluate the effectiveness of HABIT-ILE in assessing improvements in gross and fine motor function, ...

7. mdpi.com mdpi.com/2076-328X/13/8/681

Bimanual Movement Characteristics and Real-World ... Hand–arm bimanual intensive therapy (HABIT) is a well-established intervention to improve hand function and bimanual coordination in children with UCP [3].