Does Wearing Tetra-Grip Improve Arm Function in Children... | NCT03647761

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

NCT03647761

Sponsor

University of Texas Southwestern Medical Center

Status

Terminated

Last Update Posted

Jul 5, 2022Actual

Enrollment

2Actual

Phase

Not Applicable

Conditions

Neonatal Brachial Plexus Palsy

Interventions

Tetra-grip

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Covid19, lack of manpower

Expanded Access Info

Start Date

May 1, 2019Actual

Primary Completion Date

May 18, 2022Actual

Completion Date

May 18, 2022Actual

First Submitted Date

Aug 22, 2018

First Submission Date that Met QC Criteria

Aug 23, 2018

First Posted Date

Aug 27, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 29, 2022

Last Update Posted Date

Jul 5, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Robert Rinaldi, Principal Investigator, University of Texas Southwestern Medical CenterPrincipal Investigator

Lead Sponsor

University of Texas Southwestern Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention	Standard of care
Treatment	Experimental	Tetra-grip applied	Device: Tetra-grip

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tetra-grip	Device	Tetra-grip is a tubular elastic bandage that provides both compression and support	Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

7 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Medical Center Dallas		Dallas	Texas	75235	United States

Condition Browse Module

MeSH Terms

ID	Term
D000076984	Neonatal Brachial Plexus Palsy

Ancestor Terms

ID	Term
D020516	Brachial Plexus Neuropathies
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided