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

Neonatal Brachial Plexus Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03647761
• Other study ID #: STU 022018-069
• Status: Terminated
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: May 18, 2022

Study information

• Verified date: June 2022
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: May 18, 2022
• Est. primary completion date: May 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Neonatal Brachial Plexus Palsy

Intervention

Device:
• Tetra-grip
Tetra-grip is a tubular elastic bandage that provides both compression and support

Locations

Country	Name	City	State
United States	Children's Medical Center Dallas	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assisting Hand Assessment (AHA)	AHA measures hand function evaluation for children with unilateral upper limb disabilities	At the end of standard OT sessions usually lasting 3 months.