Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000029998
Ethics application status
Approved
Date submitted
24/08/2019
Date registered
20/01/2020
Date last updated
20/01/2020
Date data sharing statement initially provided
20/01/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Open Observational Multicenter Study on Effectiveness of Robotic Exercise (End Effector Vs Exoscheleton) for Functional Recovery of Upper Limb in stroke outcomes (ROBOTAS)
Scientific title
Effectiveness of Robotic Exercise (End Effector Vs Exoscheleton) for Functional Recovery of Upper Limb in stroke outcomes: an Observational Multicenter Study (ROBOTAS)
Secondary ID [1] 298078 0
n/a
Universal Trial Number (UTN)
U1111-1232-4359
Trial acronym
ROBOTAS
Linked study record
n/a

Health condition
Health condition(s) or problem(s) studied:
stroke 312582 0
Condition category
Condition code
Stroke 311094 311094 0 0
Ischaemic
Stroke 311095 311095 0 0
Haemorrhagic

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
3
Target follow-up type
Months
Description of intervention(s) / exposure
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).
Intervention code [1] 314309 0
Diagnosis / Prognosis
Comparator / control treatment
The comparator consists in
i) 20 session of 40 minutes (including 10 minutes for set-up) robotic end effector arm rehabilitation
ii) 3 or 5 times per week;
iii) delivered in hospital
iv) by trained physioterapist in 1:1 ratio with patients.
Control group
Active

Outcomes
Primary outcome [1] 319877 0
Fugl Meyer Assessment Scale (Fugl Meyer A 1975) - Upper limb (FMA) 0-66
Timepoint [1] 319877 0
baseline (T0)
weeks 4, (T1)
weeks 8 (T2)
3 months after the end of the treatment (T3)
Secondary outcome [1] 369759 0
Motricity Index for Upper Limb (Demeurisse G, 1980) ;
Timepoint [1] 369759 0
baseline (T0)
weeks 4, (T1)
weeks 8 (T2)
3 months after the end of the treatment (T3)
Secondary outcome [2] 375938 0
Modified Ashworth Scale (for the spasticity)
Timepoint [2] 375938 0
baseline (T0)
weeks 4, (T1)
weeks 8 (T2)
3 months after the end of the treatment (T3)
Secondary outcome [3] 375939 0
Numerical Rating Scale for Pain
Timepoint [3] 375939 0
baseline (T0)
weeks 4, (T1)
weeks 8 (T2)
3 months after the end of the treatment (T3)
Secondary outcome [4] 375940 0
Box & Block Test (to assess gross manual dexterity)
Timepoint [4] 375940 0
baseline (T0)
weeks 4, (T1)
weeks 8 (T2)
3 months after the end of the treatment (T3)
Secondary outcome [5] 375941 0
Frenchay Activity Index ( to assess instrumental activities of daily living)
Timepoint [5] 375941 0
baseline (T0)
weeks 4, (T1)
weeks 8 (T2)
3 months after the end of the treatment (T3)
Secondary outcome [6] 375942 0
Barthel Index (to assess global ability)
Timepoint [6] 375942 0
baseline (T0)
weeks 4, (T1)
weeks 8 (T2)
3 months after the end of the treatment (T3)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
Data analysis will be conducted by prof. Stefano Mazzoleni, from the Institute of Biorobotics, Scuola Superiore S.Anna Pisa.
The enrolled patients will be stratified in two groups: patients in the subacute phase (within three months of the stroke) and in the chronic phase (after three months from the stroke).
The results of the treatments will be analyzed based on the type of robot used: end effector and exoskeleton (treatment 2).
The values of all clinical outcome measures recorded between T0 and T2 (pre and post treatment, respectively), T0 and T1, T1 and T2, T0 and T3, T2 and T3 will be analyzed with the Wilcoxon rank test in the SigmaStat environment in the case of measurements deriving from ordinal scales and with t-tests for continuous numerical data. The statistical significance will be set at p <0.05.
The sample size, in relation to the clinically significant changes in the primary outcome, was calculated for 58 patients treated with an exoskeletal robot and 58 patients treated with end-effector in the subacute group, 83 patients treated with an exoskeletal robot and 83 for patients treated with end-effector in the group of chronic patients. More specifically, knowing the distribution of the devices in the 18 Centers that have already joined the study (9 with exoskeletal devices and 9 with robot end effector) it is believed to enroll at least 7 cases of subacute patients and 10 cases of chronic patients for Center.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
15/06/2018
Date of last participant enrolment
Anticipated
30/06/2020
Actual
Date of last data collection
Anticipated
30/10/2020
Actual
Sample size
Target
141
Accrual to date
120
Final
Recruitment outside Australia
Country [1] 21439 0
Italy
State/province [1] 21439 0

Funding & Sponsors
Funding source category [1] 302608 0
Hospital
Name [1] 302608 0
ASST monza - Ospedale San Gerardo
Country [1] 302608 0
Italy
Primary sponsor type
Hospital
Name
ASST monza - Ospedale San Gerardo
Address
Via G. B. Pergolesi, 33, 20900 Monza MB
Country
Italy
Secondary sponsor category [1] 302521 0
University
Name [1] 302521 0
Polo Sant' Anna Valdera, University "Scuola Superiore Sant' Anna"
Address [1] 302521 0

Polo Sant' Anna Valdera, Scuola Superiore Sant' Anna, The BioRobotics Institute, Viale Rinaldo Piaggio, 34, 56025 Pontedera (PI). Italy
Country [1] 302521 0
Italy
Secondary sponsor category [2] 302543 0
University
Name [2] 302543 0
San Raffaele University,
Address [2] 302543 0
Via di Val Cannuta, 247, 00166 Roma. Italy.
Country [2] 302543 0
Italy

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303243 0
COMITATO ETICO BRIANZA
Ethics committee address [1] 303243 0
Ethics committee country [1] 303243 0
Italy
Date submitted for ethics approval [1] 303243 0
27/11/2017
Approval date [1] 303243 0
19/12/2017
Ethics approval number [1] 303243 0
n/a

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92982 0
Dr Donatella Bonaiuti
Address 92982 0
Department of Physical Medicine and Rehabilitation, S. Gerardo Hospital, Via G. B. Pergolesi, 33, 20900 Monza (MB), Italy
Country 92982 0
Italy
Phone 92982 0
+39 039 2339531
Fax 92982 0
Email 92982 0
[email protected]
Contact person for public queries
Name 92983 0
Giovanni Morone
Address 92983 0
IRCCS Fondazione Santa Lucia, Via Ardeatina, 306 00179. Rome
Country 92983 0
Italy
Phone 92983 0
+39 06 51501005
Fax 92983 0
Email 92983 0
[email protected]
Contact person for scientific queries
Name 92984 0
Giovanni Morone
Address 92984 0
IRCCS Fondazione Santa Lucia, Via Ardeatina, 306 00179. Rome
Country 92984 0
Italy
Phone 92984 0
+39 06 51501005
Fax 92984 0
Email 92984 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No patient permission to share data outside this study.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseRobot-assisted training for upper limb in stroke (ROBOTAS): An observational, multicenter study to identify determinants of efficacy. https://dx.doi.org/10.3390/jcm10225245
N.B. These documents automatically identified may not have been verified by the study sponsor.