Clinical trial NCT03319992: Upper Limb Task-Oriented Rehabilitation With Robotic Exoskeleton for Hemiparetic Stroke Patients
Official title: Robotic Assisted Task-Oriented Rehabilitation of Upper Limb for Chronic Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cerebrovascular Accident (CVA)
Chronic Disease
Stroke Rehabilitation
Keywords: Robotics [H01.671.293.643]
Exoskeleton Device [E07.341]
Rehabilitation Research [H01.770.644.145.472]
Physical and Rehabilitation Medicine [H02.403.680]
Exercise Therapy [E02.779.483]
Patient Outcome Assessment [N05.715.360.575.575.399]
Lead sponsor: Scuola Superiore Sant'Anna di Pisa
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliero, Universitaria Pisana
First posted: 2017-10-24
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effects of an assisted rehabilitation treatment through a robotic exoskeleton device on the functional recovery in a group of patients with hemiparesis from lesion of the first motor neuron (post-stroke), compared with a group of patients subjected to a conventional rehabilitation treatment. The patients enrolled in the study are chronic stroke injured with right hemiparesis of moderate to severe degree, by the system injury pyramid, never undergoing rehabilitation treatment with robots.


Eligibility criteria: Inclusion Criteria:

* diagnosis of a first-ever left hemisphere ischemic or hemorrhagic stroke at least 6 months prior to entry into the study;
* minimum ability for shoulder humeral elevation;
* upper-extremity motor function Fugl-Meyer (FM) score ≥ 15(out of 66);
* absence of neurological or muscular disorders that interfere with neuromuscular function;
* absence of severe cognitive deficits that would limit patients' ability to complete the study;
* minimum score of 2 in the Modified Ashworth Scale;
* not participating in any experimental rehabilitation or drug studies at the same time
* no previous experience with robotic treatments.

Primary outcomes:
measure: Change in Fugl-Meyer Assessment (FMA( Score
timeFrame: baseline and 6 weeks
Secondary outcomes:
measure: Functional scale: Bimanual Activity Test (BAT)
timeFrame: baseline and 6 weeks
measure: Modified Ashworth (MA) scale
timeFrame: baseline and 6 weeks
measure: Robotic kinesiological assessment of movement: Execution Time
timeFrame: At end of each session, during 6 weeks of enrollment in treatment
measure: Robotic kinesiological assessment of movement: Smoothness index
timeFrame: At end of each session, during 6 weeks of enrollment in treatment
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: University Hospital of Pisa
Study officials:
affiliation: U.O. Neurorehabilitation Division, Azienda Ospedaliero-Universitaria Pisana (AOUP)
name: Carmelo Carmelo, Carmelo
role: STUDY_DIRECTOR
References:
citation: Frisoli A, Barsotti M, Sotgiu E, Lamola G, Procopio C, Chisari C. A randomized clinical control study on the efficacy of three-dimensional upper limb robotic exoskeleton training in chronic stroke. J Neuroeng Rehabil. 2022 Feb 4;19(1):14. doi: 10.1186/s12984-022-00991-y.