Robotic treatment
DevicePassive/active elbow mobilizzation provided by NEUROExos Elbow Module Robotic device
NCT Number: NCT02934646
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.
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Notify Me18 year–79 year
All sexes
Interventional
Phase 2
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Passive/active elbow mobilizzation provided by NEUROExos Elbow Module Robotic device
Time frame: 2 weeks
Impairmente level maesure according to ICF
Time frame: 2 weeks
Impairmente level maesure according to ICF
Time frame: 2 weeks
Paramenter directly exterted by the device
Time frame: 2 weeks
Paramenter directly exterted by the device
Auxilium Vitae Volterra
Other
Clinical Validation of a Powered Exoskeleton for the Treatment of Elbow Spasticity: Phase II Study
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