NCT02934646

Powered Exoskeleton for the Treatment of Elbow Spasticity

Clinical Validation of a Powered Exoskeleton for the Treatment of Elbow Spasticity: Phase II Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Auxilium Vitae Volterra · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Muscle Spasticity
• Stroke

Interventions

Type	Name	Description
DEVICE	Robotic treatment	Passive/active elbow mobilizzation provided by NEUROExos Elbow Module Robotic device

Timeline

• Start date: 2014-07-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2016-10-17
• Last updated: 2018-07-26