NCT03780322

Effectiveness of Armeo Spring Pediatric in Obstetric Brachial Plexus Injury

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Sociedad Pro Ayuda del Niño Lisiado · Academic / Other
• Sex: All
• Age: 5 Years – 8 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Brachial Plexus Neuropathies
• Brachial Plexus Birth Palsy

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2018-12-18
• Primary completion: 2019-01-31
• Completion: 2023-07-10
• First posted: 2018-12-19
• Last updated: 2023-11-24

Locations

1 site across 1 country: Chile