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NCT Number: NCT03780322

Effectiveness of Armeo Spring Pediatric in 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.

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Key information

Conditions

Brachial Plexus Neuropathies Brachial Plexus Birth Palsy Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

5 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Instituto Teleton

Concepción, Biobio, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Armeo Spring Pediatric

Device

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.

Conventional physical and occupational therapy

Other

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

  • Upper extremity weight bearing exercises.
  • Approximation techniques on wrist, elbow and shoulder.
  • Proprioceptive neuromuscular facilitation: shoulder flection, adduction and external rotation and shoulder flection, abduction and external rotation.
  • Scapulothoracic joint mobilization.
  • Stretching of shoulder abductors and external rotators.
  • 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Upper extremity passive range of movement

    Time frame: 0 weeks, 5 weeks, 17 weeks and 29 weeks

    Will be measured by goniometry

  2. 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.

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

Sociedad Pro Ayuda del Niño Lisiado

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2023
First posted
Dec 19, 2018
Registry last updated
Nov 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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