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Remote Ischemic Conditioning, Bimanual Skill Learning, and Corticospinal Excitability

NCT05355883 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2025-07-16

No results posted yet for this study

Summary

Unilateral cerebral palsy (UCP) is a leading cause of childhood disability. An early brain injury impairs the upper extremity function, bimanual coordination, and impacts the child's independence. The existing therapeutic interventions have higher training doses and modest effect sizes. Thus, there is a critical need to find an effective priming agent to enhance bimanual skill learning in children with UCP. This study aims to determine the effects of a novel priming agent, remote ischemic conditioning (RIC), when paired with intensive bimanual skill training to enhance bimanual skill learning and to augment skill dependent plasticity in children with UCP.

Conditions

  • Unilateral Cerebral Palsy
  • Hemiplegic Cerebral Palsy
  • Remote Ischemic Conditioning

Interventions

BEHAVIORAL

Remote Ischemic Conditioning (RIC)

See descriptions under arm/group descriptions. RIC is delivered for 5 intervention visits. Visits 1 is the pre-training assessment visit, visits 2-6 are RIC plus training visits, visit 7 is a post-training assessment visit.

BEHAVIORAL

Sham conditioning

See descriptions under arm/group descriptions. Sham conditioning is delivered for 5 intervention visits. Visits 1 is the pre-training assessment visit, visits 2-6 are RIC plus training visits, visit 7 is a post-training assessment visit.

BEHAVIORAL

Hand Arm Bimanual Intensive Therapy (HABIT)

HABIT is a child-friendly, intensive intervention directed at improving bimanual coordination and function of the affected arm. The intervention employed in this study includes various age-appropriate fine and gross motor bimanual activities that will be delivered in a play context. Children practice bimanual activities for 6 hours per day, 5 days per week, for 1 week.

BEHAVIORAL

Bimanual Cup Stacking Training

Children practices bimanual cup stacking, 15 trials/day for 5 consecutive day.

BEHAVIORAL

Balance training

All children undergo training on a balance board, learning to hold the board level with equal weight on each leg and using various bilateral upper extremity strategies. Participants perform the balance task for 15, 30-second trials per day at visits 2-6.

Sponsors & Collaborators

  • East Carolina University

    lead OTHER

Principal Investigators

  • Swati Surkar · East Carolina University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-18
Primary Completion
2024-12-31
Completion
2025-05-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05355883 on ClinicalTrials.gov