CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 12 enrolled
Drug / intervention
Armeo Spring Pediatric +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03780322
NCT03780322Phase 4Completed

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

Sociedad Pro Ayuda del Niño Lisiado·interventional·Posted Dec 19, 2018·Updated Nov 24, 2023

In Brief

A Phase 4 clinical trial evaluating Armeo Spring Pediatric and Conventional physical and occupational therapy for Brachial Plexus Neuropathies and Brachial Plexus Birth Palsy. Completed, enrolled 12 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChile
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedDec 19, 2018
Enrollment StartDec 18, 2018
Primary CompletionJan 31, 2019
Study CompletionJul 10, 2023
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 7.5 years ago

Interventions

Armeo Spring Pediatricdevice

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 therapyother

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.