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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
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02934646
Enrollment
20
Registered
2016-10-17
Start date
2014-07-31
Completion date
2016-07-31
Last updated
2018-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle Spasticity, Stroke

Keywords

Robotics, Upper Extremity

Brief 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.

Interventions

Passive/active elbow mobilizzation provided by NEUROExos Elbow Module Robotic device

Sponsors

Azienda USL Toscana Nord Ovest
CollaboratorOTHER
Scuola Superiore Sant'Anna di Pisa
CollaboratorOTHER
Auxilium Vitae Volterra
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No

Inclusion criteria

1. Upper limb spasticity due to neurological impairment; 2. Cognitive abilities sufficient for understanding instructions; 3. Absence of severe pain assessed as Visual Analogic Score (VAS) \< 4 (range 0-10).

Exclusion criteria

1. Unstable general clinical conditions; 2. Unability to keep sitting posture; 3. Tendon retractions limiting upper limb joints range of motion.

Design outcomes

Primary

MeasureTime frameDescription
Modified Ashworth Scale2 weeksImpairmente level maesure according to ICF

Secondary

MeasureTime frameDescription
Range of Motion2 weeksImpairmente level maesure according to ICF
Maximum Extension Torque2 weeksParamenter directly exterted by the device
Zero-Torque Angle2 weeksParamenter directly exterted by the device

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026