Effectiveness of Armeo Spring Pediatric in Obstetric Brachial Plexus Injury

January 20, 2022 updated by: Leslie Stuardo, Sociedad Pro Ayuda del Niño Lisiado

Effectiveness of Armeo Spring Pediatric in Children With Narakas I Obstetric Brachial Plexus Injury

The investigators seek to evaluate the effectiveness of Armeo®Spring Pediatric training, as compared to conventional treatment, in improving upper extremity function in children with Narakas I brachial plexus injury, aged 5-8 years, using the Mallet modified scale and passive range of movement, immediately post intervention and at 3 and 6 months´ follow up. The investigators will also monitor the appearance of adverse effects during and post intervention, with a follow up at 3 and 6 months.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Obstetric brachial plexus injury is caused by damage of the cervical nerve roots C5-T1 during delivery. It has traditionally been treated with occupational and physical therapy during the first few months, evaluating at 1, 3 and 6 months if primary surgery is required. The goal of primary surgery is to repair the damaged nerve roots and restore neural function. Despite surgery, a large percentage of children will remain with varying degrees of paralysis. Since Narakas I ("Erb's") paralysis is the most common, motor sequelae usually involve limited shoulder abduction, restricted shoulder external rotation and elbow flexion contracture. This sequelae requires ongoing physical and occupational therapy, especially during school age, to ensure adequate upper extremity function and participation.

Armeo Spring Pediatric is a robotic tool that enables upper extremity training using virtual reality. Virtual reality is usually well tolerated and highly motivating to school age children. Since it's a relatively new tool, its effectiveness in the treatment of obstetric brachial plexus injury has not been documented.

This study aims to evaluate the effectiveness of Armeo Spring Pediatric training as compared to conventional therapy (occupational and physical therapy), in improving the upper extremity function of children with Narakas I (C5-C6) obstetric brachial plexus injury.

It will study two parallel groups of children ages 5-8. Both groups will receive 45 minute sessions, 3 times a week, for a total of 5 weeks (15 sessions). One group will train upper extremity function using Armeo Spring Pediatric and the other group will receive occupational and physical therapy, as detailed in protocol. They will be reevaluated at 3 and 6 months.

The appearance of adverse events, such as pain, fatigue or muscle contracture, will be documented during intervention, post intervention, and at 3 and 6 months. In the presence of one such adverse event, the training session will be suspended and the patient evaluated by physiatrist or orthopedic surgeon, with treatment if necessary. If the symptoms resolve before the next session, the patient will complete training as planned. If the symptoms are not resolved by the next session, the patient will be removed from the clinical trial until recovery.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Biobio
      • Concepcion, Biobio, Chile
        • Instituto Teleton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ages between 5 and 8 years 11 months at beginning of intervention
  • Obstetric brachial plexus injury classified as Narakas I
  • Legal guardian signs informed consent form

Exclusion Criteria:

  • Evident shoulder or elbow dislocation during physical or radiological examination
  • Elbow flexion contracture of 40º or more
  • Pain during shoulder or elbow manipulation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Armeo Spring Pediatric
This group will receive training with Armeo Spring Pediatric in 45 minute sessions, 3 times a week, for a total of 15 sessions
Device: Armeo Spring Pediatric

Before intervention, the robotic device will be adjusted to the user's unique dimensions to avoid injury.

Each 45 minute session will include active upper extremity shoulder abduction, shoulder external rotation and/or elbow extension exercises, led by virtual reality game and supported by robotic arm. Sessions will take place 3 times a week for a total of 15 sessions.
Active Comparator: Conventional physical and occupational therapy
This group will receive combined physical and occupational therapy in 45 minute sessions, 3 times a week, for a total of 15 sessions.
Other: Conventional physical and occupational therapy

Conventional therapy will combine physical and occupational therapy, including the following activities:

  1. Upper extremity weight bearing exercises.
  2. Approximation techniques on wrist, elbow and shoulder.
  3. Proprioceptive neuromuscular facilitation: shoulder flection, adduction and external rotation and shoulder flection, abduction and external rotation.
  4. Scapulothoracic joint mobilization.
  5. Stretching of shoulder abductors and external rotators.
  6. Hand/wrist facilitation exercises (with ball). This will be carried out in 45 minute sessions, 3 times a week, for a total of 15 sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Modified Mallet Scale
Time Frame: 0 weeks, 5 weeks, 17 weeks, 29 weeks

It measures arm function in 7 different positions: arm at rest, shoulder external rotation, shoulder abduction, hand to neck, hand to mouth, hand to back and supination. Each position can be given a subscore from 1 (very altered) to 5 (almost normal), with a total score of 35. A higher score means better function (closer to normal movement or position).

In this case, the investigators will evaluate change in Modified Mallet Scale between baseline (0 weeks), post treatment (5 weeks) and follow up (17 and 29 weeks). It will take into account changes in total scores and subscores in different positions.
0 weeks, 5 weeks, 17 weeks, 29 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Upper extremity passive range of movement
Time Frame: 0 weeks, 5 weeks, 17 weeks and 29 weeks
Will be measured by goniometry
0 weeks, 5 weeks, 17 weeks and 29 weeks
Adverse events: pain.
Time Frame: 5 weeks, 17 weeks and 29 weeks

Will be measured by Visual Analogue Scale. The visual analogue scale is a unidimensional measure of pain intensity. The patient marks on the line the point that they feel represents their perception of their current state. The investigator will then measure in millimeters the distance from left to right (0-100 mm) to quantify the amount of pain. A low score means less intense pain and a high score means more severe pain.

The Visual Analogue Scale uses many formats (straight line, boxes, happy/sad faces). Because of the age of the study population in this clinical trial, the investigators have decided to use the happy/sad faces scale.

At 5, 17 and 29 weeks, the patient will be asked to document the pain they feel at that moment, not during the treatment.
5 weeks, 17 weeks and 29 weeks
Adverse events: fatigue
Time Frame: 5 weeks, 17 weeks and 29 weeks

Will be measured by Borg Scale The Borg Scale is an instrument that quantifies the exertion perceived by the patient with a score from 0-10, as follows: 0 = at rest; 1 = very easy, 2 = somewhat easy, 3 = moderate; 4 = somewhat hard, 5-6 = hard; 7-8 = really, really hard; 8-9 = really, really, really hard; 10 = maximal effort.

At 5 weeks, the patient will be asked to document the fatigue they felt during the treatment.

At 17 and 29 weeks, they will be asked to document the fatigue they feel at that moment.
5 weeks, 17 weeks and 29 weeks
Adverse events: muscle contracture
Time Frame: 5 weeks, 17 weeks and 29 weeks
Will only be recorded if present/absent, since there is no scale to measure it
5 weeks, 17 weeks and 29 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sociedad Pro Ayuda del Niño Lisiado

Investigators

  • Study Chair: Ines Salas, MD, Sociedad Pro Ayuda del Niño Lisiado

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2018

Primary Completion (Actual)

January 31, 2019

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

December 10, 2018

First Submitted That Met QC Criteria

December 17, 2018

First Posted (Actual)

December 19, 2018

Study Record Updates

Last Update Posted (Actual)

January 21, 2022

Last Update Submitted That Met QC Criteria

January 20, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ArmeoOBPIConcepcion

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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