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Upper Limb Training Modalities in Patients With Stroke

NCT03590314 · Universita di Verona · Updated 18 July 2018

What is being tested
Experimental group - robot assisted arm training (Armotion®); Control group - conventional treatment
For
Stroke
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years and older. About 32 people. The full rules are on the registry page.
Where
Italy
When
Starts or started Jan 2017, ends July 2018. Registered 18 July 2018.
Results
None posted yet.

In the researchers' words

To date, evidence of the effects of robotic training combined with OnabotulinumtoxinA focal treatment for spasticity is limited. The objective of this study were to compare the effects of robotic training against conventional rehabilitation on functional recovery, strength and spasticity, in stroke patients who underwent OnabotulinumtoxinA focal treatment for spasticity. We performed a single-blind, randomized, controlled trial involving 24 outpatients with diagnoses of stroke, divided in two groups (experimental and control group). Experimental group received specific robotic training for the upper limb with the device Armotion/Motore (Reha Technology AG, Olten, Switzerland). Our primary outcome was Fugl-Meyer Assessment Motor Scale (FMA). Secondary outcome were Action Research Arm Test (ARAT), Modified Ashworth Scale (MAS), Medical Research Council Scale (MRC) and surface Electromyography (EMG). 14 healthy age-matched controls underwent one session of sEMG acquisition to collect normative data.
ClinicalTrials.gov, NCT03590314

Sites

  • Azienta Ospedaliera, SSO Rehabilitation Unit, VeronaVerona, Italy, Verona, Italy