Powered Exoskeleton for the Treatment of Elbow Spasticity

Auxilium Vitae Volterra

Status and phase: Completed; Phase 2

Conditions: Stroke; Muscle Spasticity

Treatments: Device: Robotic treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02934646

RN20161

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Subacute stroke patients

Experimental group

Description:

Elbow passive/active robotic treatment provided by NEUROExos Elbow Module

Treatment:

Device: Robotic treatment