Back to resultsDoes Wearing Tetra-Grip Improve Arm Function in Children Diagnosed With Neonatal Brachial Plexus Palsy?
Primary Purpose
Neonatal Brachial Plexus Palsy
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tetra-grip
Sponsored by
About this trial
This is an interventional treatment trial for Neonatal Brachial Plexus Palsy focused on measuring Tetra-grip, Assisting Hand Assessment
Eligibility 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
Sites / Locations
- Children's Medical Center Dallas
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Treatment
Arm Description
Standard of care
Tetra-grip applied
Outcomes
Primary Outcome Measures
Assisting Hand Assessment (AHA)
AHA measures hand function evaluation for children with unilateral upper limb disabilities
Secondary Outcome Measures
Full Information
NCT ID
NCT03647761
First Posted
August 22, 2018
Last Updated
June 29, 2022
Sponsor
University of Texas Southwestern Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03647761
Brief Title
Does Wearing Tetra-Grip Improve Arm Function in Children Diagnosed With Neonatal Brachial Plexus Palsy?
Official Title
Does Wearing Tetra-Grip Improve Upper Extremity Function in Children Diagnosed With Neonatal Brachial Plexus Palsy?
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
Covid19, lack of manpower
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
May 18, 2022 (Actual)
Study Completion Date
May 18, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Brachial Plexus Palsy
Keywords
Tetra-grip, Assisting Hand Assessment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard of care
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Tetra-grip applied
Intervention Type
Device
Intervention Name(s)
Tetra-grip
Intervention Description
Tetra-grip is a tubular elastic bandage that provides both compression and support
Primary Outcome Measure Information:
Title
Assisting Hand Assessment (AHA)
Description
AHA measures hand function evaluation for children with unilateral upper limb disabilities
Time Frame
At the end of standard OT sessions usually lasting 3 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Children's Medical Center Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Does Wearing Tetra-Grip Improve Arm Function in Children Diagnosed With Neonatal Brachial Plexus Palsy?
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