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Effectiveness of Armeo Spring Pediatric in Obstetric Brachial Plexus Injury

NCT03780322 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-11-24

No results posted yet for this study

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.

Conditions

  • Brachial Plexus Neuropathies
  • Brachial Plexus Birth Palsy

Interventions

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.

Sponsors & Collaborators

  • Sociedad Pro Ayuda del Niño Lisiado

    lead OTHER

Principal Investigators

  • Ines Salas, MD · Sociedad Pro Ayuda del Niño Lisiado

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-18
Primary Completion
2019-01-31
Completion
2023-07-10

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03780322 on ClinicalTrials.gov