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Powered Exoskeleton for the Treatment of Elbow Spasticity

NCT02934646 · Auxilium Vitae Volterra · Updated 26 July 2018

What is being tested
Robotic treatment
For
Muscle Spasticity; Stroke
Kind of study
Tests a treatment or device on volunteers. Phase 2.
Who can join
Ages 18 years to 79 years. About 20 people. The full rules are on the registry page.
Where
Not stated
When
Starts or started July 2014, ends July 2016. Registered 17 Oct 2016.
Results
None posted yet.

In the researchers' words

This is a phase-II clinical study to assess whether intense passive mobilization of the elbow during the early stage is effective in preventing spasticity from occurring at a later stage. A group of subacute stroke patients was treated with the device named NEUROExos Elbow Module (NEEM) on a daily basis, in addition to traditional physical therapy. The outcome was assessed in terms of (i) system safety, (ii) system usability and (iii) treatment efficacy. Investigators expected that intense therapy performed in the sub-acute phase following the stroke would be effective in preventing elbow spasticity from occurring at a later stage (i.e. 3-4 months after the stroke), the latter being quantified by means of the Modified Ashworth Scale (MAS). Similarly to other phase-II studies in the field of post-stroke rehabilitation, the present study will include only one group of patients. As a secondary objective, similarly to other studies with robot-assisted therapy, investigators wiil test the ability of this system to be used for assessing rehabilitation outcome. Investigators will introduce novel evaluation metrics based on the kinematics and kinetics variables recorded by the NEEM and compared them with MAS values.
ClinicalTrials.gov, NCT02934646