Neonatal Brachial Plexus PalsyNCT03647761
Does Wearing Tetra-Grip Improve Arm Function in Children Diagnosed With Neonatal Brachial Plexus Palsy?
A study testing Tetra-grip in people with Neonatal Brachial Plexus Palsy, run by University of Texas Southwestern Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Neonatal Brachial Plexus Palsy
- What is being tested?
- Tetra-grip
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 18 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 3 - 7 years old
- male or female
- non-dominant upper extremity brachial plexus injury
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Medical Center Dallas
Dallas, Texas, 75235
About this study
Official title: Does Wearing Tetra-Grip Improve Upper Extremity Function in Children Diagnosed With Neonatal Brachial Plexus Palsy?
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.
Read the 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.
- Conditions
- Neonatal Brachial Plexus Palsy
- Being tested
- Tetra-grip
- Keywords
- Tetra-grip, Assisting Hand Assessment
- Medical subject headings
- Neonatal Brachial Plexus Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetra-gripDevice
Tetra-grip is a tubular elastic bandage that provides both compression and support
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard of care |
| Treatment | Experimental | Tetra-grip applied Receives: Device: Tetra-grip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assisting Hand Assessment (AHA)
AHA measures hand function evaluation for children with unilateral upper limb disabilities
Measured: At the end of standard OT sessions usually lasting 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start1 May 2019
- Primary completion18 May 2022
- Study completion18 May 2022
Why it stopped: Covid19, lack of manpower
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Brachial Plexus PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Rinaldi, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03647761
- Sponsor's protocol ID
- STU 022018-069
- Status last verified
- Jun 2022
- First submitted
- 22 Aug 2018
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Wearing Tetra-Grip Improve Upper Extremity Function in Children Diagnosed With Neonatal Brachial Plexus Palsy?
- ClinicalTrials.gov ID
- NCT03647761
- Acronym / sponsor ID
- STU 022018-069
- Conditions
- Neonatal Brachial Plexus Palsy
- Keywords
- Tetra-grip, Assisting Hand Assessment
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Covid19, lack of manpower
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 18 May 2022 (actual)
- Study completion
- 18 May 2022 (actual)
- First posted
- 27 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard of care |
| Treatment | Experimental | Device: Tetra-gripTetra-grip applied |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 3 - 7 years old
- male or female
- non-dominant upper extremity brachial plexus injury
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tetra-gripTetra-grip is a tubular elastic bandage that provides both compression and support | Device | Treatment |
Primary outcome
Assisting Hand Assessment (AHA)
Time frame: At the end of standard OT sessions usually lasting 3 months.
AHA measures hand function evaluation for children with unilateral upper limb disabilities
Results and safety
The study was stopped early (reason given: Covid19, lack of manpower). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
Related trials for Neonatal Brachial Plexus Palsy
Not yet recruitingObservational study
Investigation of the Relationship Between Shoulder Alpha Angle and Humeral Head Displacement Percentage Measured by Ultrasonography in Neonatal Brachial Plexus Palsy Infants With Clinical Parameters
Glenohumeral Subluxation, Neonatal Brachial Plexus Palsy
RecruitingPhase 3
Effectiveness and Safety of Early Intramuscular Botulinum Toxin Injections to Prevent Shoulder Deformity in Babies With Obstetrical Brachial Plexus Palsy
Obstetrical Brachial Plexus Palsy
Not yet recruitingObservational study
Kinematic Analysis of Latissimus Dorsi Transfer Results for Shoulder External Rotation Resuscitation
Osbtetric Brachial Plexus Palsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tetra-grip in people with Neonatal Brachial Plexus Palsy, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Covid19, lack of manpower). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assisting Hand Assessment (AHA) (time frame: At the end of standard OT sessions usually lasting 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2022.