Remote Ischemic Conditioning (RIC) for Cerebral Palsy

Dept. of Physical Therapy, East Carolina University, Greenville, NC
Targeting 3 different conditionsRemote Ischemic Conditioning (RIC) +4 morePhase 2RecruitingLed by Swati SurkarResearch Sponsored by East Carolina University

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.

Eligible Conditions
  • Unilateral Cerebral Palsy
  • Remote Ischemic Conditioning
  • Cerebral Palsy

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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Children between 6 to 16 years old who have been diagnosed with cerebral palsy affecting only one side of their body.
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You can stack 3 cups in 2 minutes.

Timeline

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
~730
Remote Ischemic Conditioning (RIC)
2015
Completed Phase 3
~410

Find a site

Who is running the clinical trial?

East Carolina UniversityLead Sponsor
102 Previous Clinical Trials
37,415 Total Patients Enrolled
2 Trials studying Cerebral Palsy
70 Patients Enrolled for Cerebral Palsy
Swati SurkarPrincipal Investigator
East Carolina University

Media Library

Bimanual Cup Stacking Training Clinical Trial Eligibility Overview. Trial Name: NCT05355883 — Phase 2
Cerebral Palsy Research Study Groups: Remote Ischemic Conditioning (RIC), Sham Conditioning
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

Is this study accepting participants of all ages, including those younger than 65 years old?

"As per the parameters of this trial, individuals between 6 and 16 years old can be enrolled."

Answered by AI
~4 spots leftby Dec 2023