NCT03647761

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 27, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2022

Completed
Last Updated

July 5, 2022

Status Verified

June 1, 2022

Enrollment Period

3 years

First QC Date

August 22, 2018

Last Update Submit

June 29, 2022

Conditions

Neonatal Brachial Plexus Palsy

Keywords

Tetra-gripAssisting Hand Assessment

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

Control

NO INTERVENTION

Standard of care

Treatment

EXPERIMENTAL

Tetra-grip applied

Device: Tetra-grip

Interventions

Tetra-gripDEVICE

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

Treatment

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Medical Center Dallas

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Neonatal Brachial Plexus Palsy

Condition Hierarchy (Ancestors)

Brachial Plexus NeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesBirth InjuriesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 22, 2018

First Posted

August 27, 2018

Study Start

May 1, 2019

Primary Completion

May 18, 2022

Study Completion

May 18, 2022

Last Updated

July 5, 2022

Record last verified: 2022-06

Locations

US(1)