CompletedPhase 4

Effectiveness of Armeo Spring Pediatric in Obstetric Brachial Plexus Injury

Chile12 participantsStarted 2018-12-18

Plain-language 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.

Who can participate

Age range5 Years – 8 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in Modified Mallet Scale

Timeframe: 0 weeks, 5 weeks, 17 weeks, 29 weeks

Trial details

NCT IDNCT03780322

SponsorSociedad Pro Ayuda del Niño Lisiado

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-01-31

View on ClinicalTrials.gov More Brachial Plexus Neuropathies trials