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Open Observational Multicenter Study on Effectiveness of Robotic Exercise (End Effector Vs Exoscheleton) for Functional Recovery of Upper Limb in stroke outcomes (ROBOTAS)

Effectiveness of Robotic Exercise (End Effector Vs Exoscheleton) for Functional Recovery of Upper Limb in stroke outcomes: an Observational Multicenter Study (ROBOTAS)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12620000029998
Acronym
ROBOTAS
Enrollment
120
Registered
2020-01-20
Start date
2018-06-15
Completion date
2020-06-30
Last updated
2020-02-03

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

Conditions

None listed

Brief summary

Currently, various robotic systems have been implemented for the rehabilitation of the upper limb in stroke outcomes. However, the characterization of the type of patient best suited to receive treatment with different robotic systems, in terms of neurological severity, type of cerebral stroke (and site of injury), distance from stroke and type of deficit (ie sensitives, sensors-motors , cognitive) remains an aspect of extreme clinical relevance but unexplored today. Moreover, the specific type of robot technology used is also not yet sufficiently investigated for its activity in the various phases of motor recovery. Understanding these aspects could on the one hand have positive repercussions on clinical practice by proposing highly customized pathways in order to promote the maximum recovery possible, on the other it could improve the scientific research sector allowing to study the recovery mechanisms promoted by specific technological devices . The objectives of the study is to evaluate the different action on upper limb recovery in stroke outcomes of robotic devices currently in use (end effector and exoskeletons). The study is conceived as a prospective multicenter observational cohort study comparing robotic devices in rehabilitation.

Interventions

Participants would have received the intervention./comparator regardless of this studySubject enrolled will perform. Both group receive Robotic treatment for 20 session (3 or 5 time per week) as per clinical routine rehabilitation procedures. The intervention includes 20 session of 40 minutes (including 10 minutes for set-up) of robotic exoskeleton arm rehabilitation (Armeo Power, Armeo Spring,T-WREX and Armin); 3 or 5 times per week in 6 weeks (according to current clinical practice), delivere

Participants would have received the intervention./comparator regardless of this studySubject enrolled will perform. Both group receive Robotic treatment for 20 session (3 or 5 time per week) as per clinical routine rehabilitation procedures. The intervention includes 20 session of 40 minutes (including 10 minutes for set-up) of robotic exoskeleton arm rehabilitation (Armeo Power, Armeo Spring,T-WREX and Armin); 3 or 5 times per week in 6 weeks (according to current clinical practice), delivered in hospital and performed by trained physioterapist in 1:1 ratio with a patients. The use of exoskeletons allow to provide functional movements assisted by robots at the shoulder, elbow and at the wrist with a videofeedback in an exergaming context. Exercises regard shoulder, elbow and hand movement assted by roibot and with a videofeedback monitor. The assistence of the robot will be progressively reduced, according to subject improvement/capacity. (For both group and according to routine clinical indications). The compartor include the same clinical routine practice with 6 weeks of robotic exercises for shoulder, elbow and hand movement assted by roibot and with a videofeedback monitor, but delivered with an end-effector device (Bimanutrack, Amadeo, MIT-MANUS InMotion 2, Nerebot).

Sponsors

ASST monza - Ospedale San Gerardo
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

a) previous documented ischemic / haemorrhagic cerebrovascular event with neuroradiological examinations (CT, MRI) with functional upper limb deficiency, with sensorimotor and monoparesis / hemiparesis deficits; b) age> 18 years; c) ability to maintain the sitting position.

Exclusion criteria

a) bilateral impairment; b) neglect, according to clinical judgment; c) cognitive or behavioral impairment that affects the understanding or execution of robotic training; d) impossibility or unavailability to provide informed consent; e) treatment with botulinum toxin in the previous 3 months and throughout the study (including follow-up) f) other serious medical problems.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026