Effects of a Robot-Assisted Arm Training Plus Hand Functional Electrical Stimulation on Recovery After Stroke: A Randomized Clinical Trial

Sofia Straudi; Andrea Baroni; Sonia Mele; Laila Craighero; Fabio Manfredini; Nicola Lamberti; Elisa Maietti; Nino Basaglia

doi:10.1016/j.apmr.2019.09.016

Effects of a Robot-Assisted Arm Training Plus Hand Functional Electrical Stimulation on Recovery After Stroke: A Randomized Clinical Trial

Arch Phys Med Rehabil. 2020 Feb;101(2):309-316. doi: 10.1016/j.apmr.2019.09.016. Epub 2019 Nov 1.

Authors

Sofia Straudi¹, Andrea Baroni², Sonia Mele³, Laila Craighero³, Fabio Manfredini⁴, Nicola Lamberti⁴, Elisa Maietti⁵, Nino Basaglia⁴

Affiliations

¹ Neuroscience and Rehabilitation Department, Ferrara University Hospital, Ferrara, Italy. Electronic address: s.straudi@ospfe.it.
² Neuroscience and Rehabilitation Department, Ferrara University Hospital, Ferrara, Italy; Doctoral Program in Translational Neurosciences and Neurotechnologies, Ferrara University, Ferrara, Italy.
³ Biomedical and Specialty Surgical Sciences Department, Ferrara University, Ferrara, Italy.
⁴ Neuroscience and Rehabilitation Department, Ferrara University Hospital, Ferrara, Italy; Biomedical and Specialty Surgical Sciences Department, Ferrara University, Ferrara, Italy.
⁵ Medical Science Department, Center for Clinical Epidemiology, Ferrara University, Ferrara, Italy; Department of Biomedical and Neuromotor Sciences, Bologna University, Bologna, Italy.

PMID: 31678222
DOI: 10.1016/j.apmr.2019.09.016

Abstract

Objective: To compare the effects of unilateral, proximal arm robot-assisted therapy combined with hand functional electrical stimulation with intensive conventional therapy for restoring arm function in survivors of subacute stroke.

Design: This was a single-blinded, randomized controlled trial.

Setting: Inpatient rehabilitation university hospital.

Participants: Patients (N=40) diagnosed as having ischemic stroke (time since stroke <8wk) and upper limb impairment were enrolled.

Interventions: Participants randomized to the experimental group received 30 sessions (5 sessions/wk) of robot-assisted arm therapy and hand functional electrical stimulation (RAT+FES). Participants randomized to the control group received a time-matched intensive conventional therapy.

Main outcome measures: The primary outcome was arm motor recovery measured with the Fugl-Meyer Motor Assessment. Secondary outcomes included motor function, arm spasticity, and activities of daily living. Measurements were performed at baseline, after 3 weeks, at the end of treatment, and at 6-month follow-up. Presence of motor evoked potentials (MEPs) was also measured at baseline.

Results: Both groups significantly improved all outcome measures except for spasticity without differences between groups. Patients with moderate impairment and presence of MEPs who underwent early rehabilitation (<30d post stroke) demonstrated the greatest clinical improvements.

Conclusions: RAT+FES was no more effective than intensive conventional arm training. However, at the same level of arm impairment and corticospinal tract integrity, it induced a higher level of arm recovery.

Trial registration: ClinicalTrials.gov NCT02267798.

Keywords: Rehabilitation; Robotics; Stroke; Transcranial magnetic stimulation; Upper extremity.

Publication types

Pragmatic Clinical Trial
Research Support, Non-U.S. Gov't

MeSH terms

Activities of Daily Living
Aged
Arm / physiopathology*
Electric Stimulation Therapy / methods*
Evoked Potentials, Motor
Exercise Therapy / methods*
Exoskeleton Device*
Female
Hand
Hospitals, University
Humans
Male
Middle Aged
Recovery of Function
Severity of Illness Index
Single-Blind Method
Stroke Rehabilitation / methods*

Associated data

ClinicalTrials.gov/NCT02267798