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Bimanual Skill Training for Cerebral Palsy (RIC Trial)

N/A

Recruiting

Research Sponsored by East Carolina University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 1 week

Summary

This trial is researching if a new priming agent can help children with UCP learn bimanual skills and improve independence.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves non-invasive priming and physical training rather than medication, traditional side effects are minimal. However, there may be temporary discomfort from the RIC procedure or fatigue from the bimanual skill training.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 1 week

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 1 week

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 1 week for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Active Motor Threshold (aMT)

Change in Bimanual Learning

Change in Resting Motor Threshold (rMT)

+1 more

Secondary study objectives

Change in Assisting Hand Assessment

Change in Goal Synchronization

Change in Hand Trajectory

+6 more

Trial Design

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.

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