Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000681550
Ethics application status
Approved
Date submitted
22/05/2015
Date registered
1/07/2015
Date last updated
1/07/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can overground walking training with a robotic servo-assistive walker versus conventional overground walking training improve walking performance in patients affected by subacute stroke.
Scientific title
Can overground walking training with a robotic servo-assistive walker versus conventional overground walking training improve walking performance in patients affected by subacute stroke.
Secondary ID [1] 286792 0
None
Universal Trial Number (UTN)
U1111-1170-4791
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subacute stroke 295167 0
Condition category
Condition code
Physical Medicine / Rehabilitation 295409 295409 0 0
Physiotherapy
Stroke 295410 295410 0 0
Ischaemic
Stroke 295682 295682 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Walking training performed by a servo assistive robotic walker supervised by a physiotherapist for 20 sessions (40 minutes per session), 5 times for week for 4 weeks + conventional physiotherapy.
Conventional physiotherapy (20 sessions, 40 minutes per session, 5 times for week for 4 weeks) involves exercise for trunk, hand recovery, exercise for tone control, exercise to improve global ability.
The overall duration of the intervention is 4 weeks and sessions are administered in one-one mode.
The i-Walker is registered as medical electrical equipment in Spain (reg. Number 477/13/EC). The i-Walker s a robotic rollator that integrates sensors and actuators.
It uses a standard 4-wheeled Rollator AD100 walker frame sized 500mm (W) x 600mm (L) x 850mm (H) modified for this purpose. Actuators are two hub motors, 100mm diameter, integrated in the rear wheels and are used for braking or helping the user. It is composed also by two modified handlebars with brake handle and force measurement; 32 strain gauges mounted in 8 bridges to measure handlebar forces and normal wheels forces, sensors are arranged in the frame to detect forces, tilt and movement, and an integrated battery supplies power.
Services provided by the i-Walker are: (i) active motor assistance to compensate lack of muscle force on climbs; (ii) active brake assistance to compensate lack muscle force on descents; (iii) active differential assistance to compensate asymmetric muscle force; (iv) recording of sensor measurements and actuators activities for later evaluation.
During the study we only used the service number 3 named “Active differential assistance to compensate unbalanced muscle force”. During training the amount of assistance (i.e. braking force in each hand) was reduced by the team following this principle: (i) assistance as needed; (ii) a progressive assistance reduction; (iii) safety concerns; (iv) patients ability to drive the device; (v) the affected leg and arm increase of spasticity.
Intervention code [1] 291948 0
Rehabilitation
Intervention code [2] 291949 0
Treatment: Devices
Comparator / control treatment
Walking training performed by parallels bar and aid of physiotherapist for 20 sessions 5 times for week for 4 weeks + a 20 session 5 times for week for 4 weeks of conventional physiotherapy.
This training last 40 minutes per sessions and is administered in one-one mode. During session the physiotherapist help patients in transferring load on paretic leg, help patients during swing phase and correct posture and symmetry of the steps depending on patients degree of ability.
Control group
Active

Outcomes
Primary outcome [1] 295145 0
Walking perfomance as measured by 10 Meter and 6 minut walking test
Timepoint [1] 295145 0
End of treatment
Secondary outcome [1] 314862 0
balance perfomance measured by tinetti scale
Timepoint [1] 314862 0
End of treatment
Secondary outcome [2] 314863 0
Trunk stability measured by accelerometer placed on L2
Timepoint [2] 314863 0
End of treatment
Secondary outcome [3] 314864 0
Falls Rate
Timepoint [3] 314864 0
Telephonic follow up at 6 month

Eligibility
Key inclusion criteria
Subjects affected by ischemic or haemorrhagic stroke in subacute phase (less then 90 days from stroke, age between 18 and 80 years, ability to perform assisted walking training at the parallel bar (Functional Ambulation Classification equal to or more than 2), presence of some degree of muscular activity to each shoulder/elbow/hand (Medical Research Council scale MRC equal to or more than 3).
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Concomitant chronic disabling pathologies, severe spasticity (score value below 4 at arm or leg on the modified Ashworth Scale); moderate/severe cognitive decline (Mini-Mental State Examination score < 24); presence of severe hemispatial neglect.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/03/2012
Actual
5/03/2012
Date of last participant enrolment
Anticipated
9/12/2013
Actual
9/12/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment outside Australia
Country [1] 6897 0
Italy
State/province [1] 6897 0
Lazio

Funding & Sponsors
Funding source category [1] 291326 0
Other
Name [1] 291326 0
European communities FP7 SHARE-it project
Country [1] 291326 0
Spain
Funding source category [2] 291327 0
Charities/Societies/Foundations
Name [2] 291327 0
Santa Lucia Foundation
Country [2] 291327 0
Italy
Primary sponsor type
Charities/Societies/Foundations
Name
Santa Lucia foundation IRCCS
Address
Via Ardeatina 306, 00179 - Roma
Country
Italy
Secondary sponsor category [1] 290098 0
None
Name [1] 290098 0
Address [1] 290098 0
Country [1] 290098 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Subjects affected by mild/moderate stroke could benefit more from physiological overground walking training than a walking-like training performed in place with a device providing a body weight support. However patients’ poor balance and motor asymmetry limit the intensity of the overground training. Aim of the study is to evaluate the effects of an overground walking training performed with the servo-assistive robotic walker (i-Walker) on walking ability, balance and risk of falls in patients with subacute stroke.
Trial website
Trial related presentations / publications
n/a
Public notes

Contacts
Principal investigator
Name 57546 0
Dr Giovanni Morone
Address 57546 0
Santa Lucia foundation, IRCCS. Via Ardeatina, 306; 00179, Roma
Country 57546 0
Italy
Phone 57546 0
+39 6 51501077
Fax 57546 0
Email 57546 0
[email protected]
Contact person for public queries
Name 57547 0
Giovanni Morone
Address 57547 0
Santa Lucia foundation, IRCCS. Via Ardeatina, 306; 00179, Roma
Country 57547 0
Italy
Phone 57547 0
+39 6 51501077
Fax 57547 0
Email 57547 0
[email protected]
Contact person for scientific queries
Name 57548 0
Giovanni Morone
Address 57548 0
Santa Lucia foundation, IRCCS. Via Ardeatina, 306; 00179, Roma
Country 57548 0
Italy
Phone 57548 0
+39 6 51501077
Fax 57548 0
Email 57548 0
[email protected]

No information has been provided regarding IPD availability


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
EmbaseOverground walking training with the i-Walker, a robotic servo-assistive device, enhances balance in patients with subacute stroke: A randomized controlled trial.2016https://dx.doi.org/10.1186/s12984-016-0155-4
N.B. These documents automatically identified may not have been verified by the study sponsor.