Bimanual Skill Training for Cerebral Palsy
(RIC Trial)
Recruiting in Palo Alto (17 mi)
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, ADHD, Cardiorespiratory disorders, others
No Placebo Group
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.12345
Is bimanual skill training safe for children with cerebral palsy?
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.12368
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.
See 1 more
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.
See 4 more
Trial 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 (Behavioral Intervention)
Trial OverviewThe 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
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Remote Ischemic Conditioning (RIC)Experimental Treatment1 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 conditioningPlacebo Group1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Dept. of Physical Therapy, East Carolina UniversityGreenville, NC
Loading ...
Who Is Running the Clinical Trial?
East Carolina UniversityLead Sponsor
References
Bimanual Skill Learning after Transcranial Direct Current Stimulation in Children with Unilateral Cerebral Palsy: A Brief Report. [2020]Bimanual skills are important for goal-oriented activities. Children with unilateral cerebral palsy (UCP) have deficits in unimanual and bimanual motor control and learning. The application of non-invasive brain stimulation with existing motor training may further promote motor learning; however, the effects of stimulation on bimanual learning have not been examined. Here, we assessed the performance of a novel bimanual skill (modified Speed Stacks task) in eight children with UCP before, during, and after a combined motor training and brain stimulation intervention. Participants received 10 days (120 min/day) of goal-oriented bimanual therapy combined initially with transcranial direct current stimulation (tDCS, 20 min/day). Results showed task improvement tapered (p
Hand and Arm Bimanual Intensive Therapy Including Lower Extremity (HABIT-ILE) in Children With Unilateral Spastic Cerebral Palsy: A Randomized Trial. [2022]Intensive bimanual training results in more improvement in hand function in children with unilateral spastic cerebral palsy (USCP) than lower intensity conventional interventions. However, it is not known whether combined upper and lower extremity training in an intensive protocol is more efficacious for upper and lower functional abilities than conventional therapies provided in usual customary care.
To constrain or not to constrain, and other stories of intensive upper extremity training for children with unilateral cerebral palsy. [2011]Impaired hand function is among the most functionally disabling symptoms of unilateral cerebral palsy. Evidence-based treatment approaches are generally lacking. However, recent approaches providing intensive upper extremity training appear promising. In this review, we first describe two such approaches, constraint-induced movement therapy (CIMT) and bimanual training (hand-arm bimanual intensive therapy). We then summarize findings across more than 100 participants in our CIMT/bimanual training studies since 1997. We show that (1) at high intensities, CIMT and bimanual training improve dexterity and bimanual upper extremity use; (2) bimanual training may allow direct practice of functionally meaningful goals, and such practice may transfer to unpracticed goals and improve bimanual coordination; (3) 90 hours of CIMT and bimanual training leads to greater improvements than 60 hours of the same treatments; (4) higher doses may be required for bimanual training; (5) increased dosing frequency and shaping may be needed for older children; and (6) combined CIMT/bimanual approaches may be useful, but require sufficient intensity. Together these findings suggest that dosage (treatment amount and frequency), more so than ingredients, may well be the key to successful training protocols, especially for older children. Such rehabilitation efforts should be 'child-friendly', and as least invasive as possible, especially because these approaches may be provided throughout development.
Combining Unimanual and Bimanual Therapies for Children with Hemiparesis: Is There an Optimal Delivery Schedule? [2023]Constraint-induced movement therapy (CIMT) and bimanual therapy (BT) are among the most effective hand therapies for children with unilateral cerebral palsy (uCP). Since they train different aspects of hand use, they likely have synergistic effects. The aim of this study was to examine the efficacy of different combinations of mCIMT and BT in an intensive occupational therapy program for children with uCP. Children (n = 35) participated in intensive modified CIMT (mCIMT) and BT, 6 weeks, 5 days/week, 6 h/day. During the first 2 weeks, children wore a mitt over the less-affected hand and engaged in functional and play activities with the affected hand. Starting in week 3, bimanual play and functional activities were added progressively, 1 hour/week. This intervention was compared to two different schedules of block interventions: (1) 3 weeks of mCIMT followed by 3 weeks of BT, and (2) 3 weeks of BT followed by 3 weeks of mCIMT. Hand function was tested before, after, and two months after therapy with the Assisting Hand Assessment (AHA), Pediatric Evaluation of Disability Inventory (PEDI), and Canadian Occupational Performance Measure (COPM). All three groups of children improved in functional independence (PEDI; p < 0.031), goal performance (COPM Performance; p < 0.0001) and satisfaction (COPM Satisfaction; p < 0.0001), which persisted two months post-intervention. All groups showed similar amounts of improvement, indicating that the delivery schedule for mCIMT and BT does not significantly impact the outcomes.
Hand-arm bimanual intensive therapy and daily functioning of children with bilateral cerebral palsy: a randomized controlled trial. [2021]To examine the efficacy of Hand-Arm Bimanual Intensive Therapy (HABIT) on daily functioning, unimanual dexterity, and bimanual performance of children with bilateral cerebral palsy (CP) compared with customary care.
The Effect of Bimanual Training with or Without Constraint on Hand Functions in Children with Unilateral Cerebral Palsy: A Non-Randomized Clinical Trial. [2018]To compare the effect of bimanual training with or without constraint on manual functions in children with unilateral cerebral palsy (UCP).
Effect of Home-based Bimanual Training in Children with Unilateral Cerebral Palsy (The COAD-study): A Case Series. [2021]Purpose: To explore the child- and parent-related effects of home-based bimanual training in children with unilateral cerebral palsy.Methods: Case series of 14 children (2-7 years) who completed goal-oriented task-specific training for 3.5 hours/week for 12 weeks by a program adopting implicit (n = 5) or explicit (n = 9) motor learning. A therapist and remedial educationalist coached parents. Progression on bimanual goals (Canadian Occupational Performance Measure (COPM)) and therapy-related parental stress (interviews) were of primary interest. Data were collected at baseline (T0), halfway through and at the end of training (T1 and T2), and after 12 weeks (T3).Results: On the COPM performance scale a clinically relevant change was seen in 50% (7/14), 86% (12/14), and 85% (11/13) of the children, at T1, T2, and T3, respectively. Some parents indicated that they had experienced stress because of the training intensity.Conclusion: The child- and parent-related effects of the home-based bimanual training programs are encouraging.
The Influence of Intense Combined Training on Upper Extremity Function in Children With Unilateral Cerebral Palsy: Does Initial Ability Matter? [2017]To examine whether level of manual ability modifies the response to an intensive program combining modified constraint and bimanual training on arm functioning children with unilateral cerebral palsy (UCP).