Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Does Wearing Tetra-Grip Improve Arm Function in Children Diagnosed With Neonatal Brachial Plexus Palsy?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03647761
Recruitment Status : Enrolling by invitation
First Posted : August 27, 2018
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
Robert Rinaldi, University of Texas Southwestern Medical Center

Brief Summary:
This study evaluates the effect of wearing a tetra-grip on the affected arm of children with neonatal brachial plexus palsy. Half of the participants will have tetra-grip applied to the arm, while the other half will not have it applied to the arm.

Condition or disease Intervention/treatment Phase
Neonatal Brachial Plexus Palsy Device: Tetra-grip Not Applicable

Detailed Description:
Tetra-grip is a tubular elastic support bandage that provides both compression and support. Previous studies have shown that by applying neoprene or athletic tape to a joint on individuals with poor proprioception or a history of joint injury, such modalities enhanced their proprioceptive recognition via stimulation of mechanoreceptors responding to skin stretch and compression during joint motion. As a result, patients have greater kinesthetic and joint position awareness of their limb.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does Wearing Tetra-Grip Improve Upper Extremity Function in Children Diagnosed With Neonatal Brachial Plexus Palsy?
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Paralysis

Arm Intervention/treatment
No Intervention: Control
Standard of care
Experimental: Treatment
Tetra-grip applied
Device: Tetra-grip
Tetra-grip is a tubular elastic bandage that provides both compression and support




Primary Outcome Measures :
  1. Assisting Hand Assessment (AHA) [ Time Frame: At the end of standard OT sessions usually lasting 3 months. ]
    AHA measures hand function evaluation for children with unilateral upper limb disabilities



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 3 - 7 years old
  • male or female
  • non-dominant upper extremity brachial plexus injury

Exclusion Criteria:

  • Botox injections to the affected extremity within the past 3 months
  • Severe muscle contractures of affected extremity that restricts functional use of the arm and hand
  • Concurrent cerebral palsy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647761


Locations
Layout table for location information
United States, Texas
Children's Medical Center Dallas
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center

Layout table for additonal information
Responsible Party: Robert Rinaldi, Principal Investigator, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03647761     History of Changes
Other Study ID Numbers: STU 022018-069
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Robert Rinaldi, University of Texas Southwestern Medical Center:
Tetra-grip
Assisting Hand Assessment

Additional relevant MeSH terms:
Layout table for MeSH terms
Neonatal Brachial Plexus Palsy
Brachial Plexus Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Birth Injuries
Infant, Newborn, Diseases
Wounds and Injuries
Tetracycline
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action