Can overground walking training with a robotic servo-assistive walker versus conventional overground walking training improve walking performance in patients affected by subacute stroke.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000681550
• Date of registration: 01/07/2015
• Prospective Registration: No
• Primary sponsor: Santa Lucia foundation IRCCS
• 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.
• Date of first enrolment: 05/03/2012
• Target sample size: 44
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000681550.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Italy

Contacts

• Name: Dr Giovanni Morone

• Name: Dr Giovanni Morone

Key inclusion & exclusion criteria

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).
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.

Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Physical Medicine / Rehabilitation - Physiotherapy

Stroke - Haemorrhagic

Stroke - Ischaemic

Subacute stroke;
Subacute stroke

Intervention(s)

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

Primary Outcome(s)

Walking perfomance as measured by 10 Meter and 6 minut walking test[End of treatment]

Secondary Outcome(s)

Trunk stability measured by accelerometer placed on L2[End of treatment]

Falls Rate[Telephonic follow up at 6 month]

balance perfomance measured by tinetti scale[End of treatment]

Secondary ID(s)

None

Source(s) of Monetary Support

European communities FP7 SHARE-it project

Santa Lucia Foundation