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

NCT03647761 — Not applicable, Terminated, 2 participants, University of Texas Southwestern Medical Center

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

Registry	NCT03647761
Status	Terminated - Covid19, lack of manpower
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	2 (Actual)
Sponsor	University of Texas Southwestern Medical Center (Other)
Conditions	Neonatal Brachial Plexus Palsy
Interventions	Tetra-grip (Device)
Dates	start 2019-05-01, primary completion 2022-05-18, completion 2022-05-18, first posted 2018-08-27, last updated 2022-07-05
Locations	1 site in United States

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Control	No intervention		Standard of care
Treatment	Experimental	Device: Tetra-grip	Tetra-grip applied

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

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 3 Years to 7 Years

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

+Locations (1)

Facility	City	Country	Status
Children's Medical Center Dallas	Dallas, Texas	United States

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