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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

Awards & highlights

RIC Trial 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.Check my eligibility

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.See study design

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.

RIC Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Active Motor Threshold (aMT)

Change in Bimanual Learning

Change in Resting Motor Threshold (rMT)

+1 more

Secondary outcome measures

Change in Assisting Hand Assessment

Change in Goal Synchronization

Change in Hand Trajectory

+6 more

RIC 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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

East Carolina UniversityLead Sponsor

107 Previous Clinical Trials

38,763 Total Patients Enrolled

2 Trials studying Cerebral Palsy

54 Patients Enrolled for Cerebral Palsy

Media Library

Bimanual Cup Stacking Training Clinical Trial Eligibility Overview. Trial Name: NCT05777070 — N/A

Cerebral Palsy Research Study Groups: Sham conditioning, Remote Ischemic Conditioning (RIC)

Cerebral Palsy Clinical Trial 2023: Bimanual Cup Stacking Training Highlights & Side Effects. Trial Name: NCT05777070 — N/A

Bimanual Cup Stacking Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT05777070 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research study permit adults as participants?

"This research seeks to enrol subjects between the ages of 8 and 16."

Answered by AI

Am I eligible to be part of this investigation?

"This study is seeking 46 participants with unilateral cerebral palsy, aged 8 to 16. Those that fit these criteria may apply for enrollment."

Answered by AI

Is the enrollment period currently open for this experiment?

"The information posted on clinicaltrials.gov reveals that this research project is presently recruiting participants, with the original post marked 11/7/2022 and last updated 3/19/2023."

Answered by AI

What is the current enrollment rate of subjects in this experiment?

"Affirmative. Clinicaltrials.gov indicates that this trial was first posted on November 7th 2022, and is actively looking for 46 participants to enroll from one medical centre."

Answered by AI

What outcomes is this medical trial striving to bring about?

"The primary endpoints of this clinical trial, which will be evaluated over a Baseline and 1 week time frame, are the Alterations in Symmetry-based Performance and Tangential Speed. Secondary outcomes encompass Variation in Hand Trajectory (the length of the 3D pathway from starting point to task completion), Modification in Temporal Linking (percentage of total task period when both hands contribute to stacking sequence during bimanual coordination) and Transition in Total Contribution Time for each hand (total time that affected/less affected hand participates)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effects of Remote Ischemic Conditioning on Bimanual Skill Learning and Corticospinal Excitability in Children With Unilateral Cerebral Palsy

Swati Manoharrao Surkar 2022. "Effects of Remote Ischemic Conditioning on Bimanual Skill Learning and Corticospinal Excitability in Children With Unilateral Cerebral Palsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05777070.

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