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Remote Ischemic Conditioning for Cerebral Palsy

Phase 2

Recruiting

Led By Swati Surkar

Research Sponsored by East Carolina University

Eligibility Criteria Checklist

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

Must have

Manual Ability Classification System (MACS) levels I-III

Children diagnosed with unilateral cerebral palsy, ages 6-16 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 1 week

Awards & highlights

Study Summary

This trial is testing whether a new priming agent can help children with UCP learn new bimanual skills and improve their hand function.

Who is the study for?

This trial is for children aged 6-16 with unilateral cerebral palsy, who can stack cups and follow instructions. They should be fairly independent in daily tasks (MACS levels I-III) and not have other developmental disabilities, seizures, metal implants, or be on certain medications.Check my eligibility

What is being tested?

The study tests if remote ischemic conditioning (RIC), a new method that temporarily restricts blood flow to limbs, can improve hand coordination when combined with intensive bimanual skill training in children with unilateral cerebral palsy.See study design

What are the potential side effects?

Potential side effects of RIC may include discomfort at the site where blood flow is restricted. The intensity of training could lead to muscle soreness or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can use my hands for daily tasks with little to some help.

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My child, aged 6-16, has been diagnosed with unilateral cerebral palsy.

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 Assisting Hand Assessment

Change in Bimanual Task Performance

Change in Resting and Active Motor Thresholds

+1 more

Secondary outcome measures

Change in Balance performance

Change in Box and Blocks Test (BBT)

Change in Hand grip and pinch strength

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Remote Ischemic Conditioning (RIC)Experimental Treatment4 Interventions

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 2-6. Intervention Hand Arm Bimanual Intensive Therapy (HABIT) Bimanual cup stacking training Balance training

Group II: Sham ConditioningPlacebo Group4 Interventions

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 2-6. Intervention Hand Arm Bimanual Intensive Therapy (HABIT) Bimanual cup stacking training Balance training

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Balance training

2014

Completed Phase 1

~790

Remote Ischemic Conditioning (RIC)

2015

Completed Phase 3

~410

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

East Carolina UniversityLead Sponsor

107 Previous Clinical Trials

38,779 Total Patients Enrolled

2 Trials studying Cerebral Palsy

70 Patients Enrolled for Cerebral Palsy

Swati SurkarPrincipal InvestigatorEast Carolina University

Media Library

Bimanual Cup Stacking Training Clinical Trial Eligibility Overview. Trial Name: NCT05355883 — Phase 2

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: NCT05355883 — Phase 2

Bimanual Cup Stacking Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT05355883 — Phase 2

Frequently Asked Questions

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

Is there an opportunity for me to partake in this clinical exploration?

"To qualify for this medical trial, candidates must be between 6 and 16 years old with a diagnosis of paralysis. The study is seeking to recruit roughly 30 individuals."

Answered by AI

Are there any vacancies left to participate in this experiment?

"According to the clinicaltrials.gov, this medical trial is still accepting participants. It was first announced on December 18th 2021 and underwent an update as recently as April 30th 2022."

Answered by AI

What objectives are being pursued through this clinical experiment?

"The primary outcome to be evaluated over a baseline and 1 week duration is the Change in Assisting Hand Assessment (AHA). Secondary metrics include variations of manual speed, dexterity and balance performance. These are measured with Box & Block Test (BBT), Nine-Hole Peg Test (NHPT) and average amount of time standing on stability platform respectively."

Answered by AI

How many participants are involved in this research endeavor?

"Affirmative. Clinicaltrials.gov details that this medical research project, which was first published on December 18th 2021, is in the process of enrolling participants. A total of 30 subjects are sought after at only one trial centre."

Answered by AI

Has Remote Ischemic Conditioning been sanctioned by the Food and Drug Administration?

"Our team at Power assessed the safety of Remote Ischemic Conditioning (RIC) as a 2, for this Phase 2 trial implies that it has some evidence supporting its security but not necessarily efficacy."

Answered by AI