NCT03566901

Robot-Assisted Stair Climbing Training

Robot-assisted Locomotor and Stair Climbing Training for Improving Mobility and Participation in Daily Activities in Persons Affected by Stroke: a Multicenter Randomized Controlled Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Universita di Verona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Stair climbing up and down is an essential part of everyday's mobility. Physiotherapy is focused on muscle strengthening, real floor walking and stairs climbing tasks, but these methods do not stress in terms of intensity stair-climbing practice. The aims of this study is to compare whether an intensive robot-assisted stair climbing training (RASCT) is more effective than conventional physiotherapy (CP) for improving stair climbing ability, gait and postural control in stroke patients.

Detailed description

Trial design: A pilot randomized (allocation ratio 1:1), single blind clinical trial (RCT) comparing the effects between the experimental \[Robot-Assisted Stair Climbing Training group (RASCT)\] and control group (Conventional Physiotherapy, CP) in improving stair climbing ability and postural control in stroke patients. The examiner will be blind to group assignment.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	G-EO System	The G-EO Systems can reproduce the gait pattern and realistically simulates the ability to carry out stairs up and stairs down. It provides real-time feedback on the patient's movements with the Visual Scenario and offers the possibility to experience augmented reality further enhance the effectiveness of each therapy session. An intelligent control (G-EO System Evolution) reacts and adapts to each patient's individual capability by either supporting the patient - active assistive mode - or increasing resistance - active mode. The G-EO Systems rehabilitation robot allows to secure the subjects with a harness while they stood on the foot plates of the machine. The foot plates has 3 DoF each, allowing to control the length and the height of the steps and the foot plate angles. The maximum step length corresponded to 550 mm, the maximum achievable height of the steps is 400 mm, the maximum angles is ±90°. The maximum speed of the foot plates is 2,3 km/h.
OTHER	Conventional Physiotherapy	Overground walking training including real stair climbing up/down and lower limb mobilization and stretching exercises.

Timeline

• Start date: 2017-10-01
• Primary completion: 2018-11-01
• Completion: 2018-11-01
• First posted: 2018-06-25
• Last updated: 2018-06-25

Locations

2 sites across 1 country: Italy