Effectiveness of Armeo Spring Pediatric in Obstetric Brachial Plexus Injury
Condition: Brachial Plexus Neuropathies; Brachial Plexus Birth Palsy
MeSH terms: Brachial Plexus Neuropathies
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

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.
    

Intervention name(s): Armeo Spring Pediatric; Conventional physical and occupational therapy
Intervention type(s): Device; Other
Intervention description(s): 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 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: brachial plexus birth palsy; Armeo®Spring Pediatric; physical therapy