Remote Ischemic Conditioning for Cerebral Palsy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether Remote Ischemic Conditioning (RIC) can improve balance and motor skills in children with cerebral palsy (CP). RIC uses a blood pressure cuff to slightly restrict blood flow for short periods, potentially helping the nervous system adapt and improve function. The study aims to determine if RIC, combined with balance training, can positively affect the spinal reflexes that often challenge movement and balance in children with CP. The trial seeks children with CP who can follow instructions and are in mainstream school settings. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance the quality of life for children with CP.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are receiving certain therapies like transcranial magnetic stimulation, you may not be eligible to participate.
What prior data suggests that remote ischemic conditioning is safe for children with cerebral palsy?
Research has shown that Remote Ischemic Conditioning (RIC) is safe and well-tolerated in children with unilateral cerebral palsy, a movement disorder affecting one side of the body. In several studies, repeated RIC caused no major side effects. These studies demonstrated that inflating a blood pressure cuff on the thigh is practical and safe for children. The findings support using RIC in future larger studies.12345
Why are researchers excited about this trial?
Unlike standard treatments for cerebral palsy, which often focus on managing symptoms through physical therapy, medications, and surgery, Remote Ischemic Conditioning (RIC) offers a novel approach by potentially protecting brain tissue. RIC is unique because it uses a simple, non-invasive method: inflating a blood pressure cuff on the leg to improve blood flow and potentially enhance brain function. Researchers are excited about RIC because it might offer a new way to improve neurological outcomes without the need for invasive procedures or medication.
What evidence suggests that remote ischemic conditioning might be an effective treatment for cerebral palsy?
This trial will compare Remote Ischemic Conditioning (RIC) with a Sham conditioning approach. Research has shown that RIC can improve movement and ease tasks when combined with training. In a previous study, 71.9% of patients who received RIC showed excellent results in physical abilities, compared to 50% in a group without RIC. This suggests that RIC might enhance physical skills. The treatment involves briefly reducing blood flow and then restoring it, which may help the brain and spinal cord adapt better. This could be especially beneficial for children with cerebral palsy, potentially improving their balance and strength.12367
Who Is on the Research Team?
Swati M Surkar, PhD
Principal Investigator
East Carolina University
Are You a Good Fit for This Trial?
This trial is for children with cerebral palsy, focusing on those who may benefit from a new intervention aimed at improving motor performance and balance. Specific eligibility criteria are not provided in the given information.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Testing and Initial Training
Participants undergo baseline testing of the soleus H-reflex and complete the first training session with conditioning and balance training
Training Sessions
Participants complete conditioning and balance training sessions
Post-Testing
Post-testing of the H-reflex is conducted to assess changes in spinal reflex excitability
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Remote Ischemic Conditioning
Trial Overview
The study tests Remote Ischemic Conditioning (RIC) combined with balance training to see if it can improve spinal reflex modulation, which could help with spasticity and balance issues in children with CP.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
RIC is achieved via blood pressure cuff inflation to at least 20 mmHg above systolic blood pressure to 200 mmHg on the thigh of more affected lower extremity. 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 - 5.
Sham conditioning is achieved via blood pressure cuff inflation to 25 mm Hg on the thigh of the more affected LE. Sham involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation and requires 45 minutes. Sham conditioning is performed on visits 1-5.
Find a Clinic Near You
Who Is Running the Clinical Trial?
East Carolina University
Lead Sponsor
Citations
Feasibility, Safety, and Tolerability of Remote Ischemic ... - PMC
Remote ischemic conditioning (RIC) was feasible in children with unilateral cerebral palsy (CP), with excellent recruitment, retention, and ...
Effects of Remote Ischemic Conditioning on Bimanual Skill ...
Investigators hypothesize that compared to sham conditioning + training, RIC + training will significantly enhance: 1) bimanual skill performance (decrease in ...
Safety and Efficacy of Remote Ischemic Conditioning in ...
A previous study showed that 71.9% of IVT patients in the RIC group had an excellent functional outcome (mRS score, 0–1) compared with 50% in ...
Feasibility, Safety, and Tolerability of Remote Ischemic ...
Results: Of 148 children screened, 51 were randomized to RIC (n = 25), sham (n = 26) groups; 48 (94.1%) completed the intervention as allocated.
effects of ischemic conditioning along with bimanual task ...
These results show that ischemic conditioning combined with bimanual task training greatly improves motor function and task efficiency in children with UCP.
Feasibility, Safety, Tolerability of Remote Ischemic ...
Conclusions: RIC is feasible, safe, and well tolerated in children with unilateral CP when delivered using a standardized protocol. These results support RIC's ...
7.
semanticscholar.org
semanticscholar.org/paper/Feasibility%2C-Safety%2C-and-Tolerability-of-Remote-in-Surkar-Gardas/82bfcc0f1e2bfc3dda9be1648c17684f8d24c722Feasibility, Safety, and Tolerability of Remote Ischemic ...
Repeated RIC is feasible, safe, and tolerable in children with unilateral CP, supporting its use in future large-scale clinical trials and supporting the ...
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