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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000681550
Enrollment
44
Registered
2015-07-01
Start date
2012-03-05
Completion date
2013-12-09
Last updated
2020-01-13

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

Conditions

None listed

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.

Interventions

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. T

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.

Sponsors

Santa Lucia foundation IRCCS
Lead SponsorCharities/Societies/Foundations

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 13, 2026