Robot-Assisted Stair Climbing Training (RASCT)

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

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.

Study Overview

• Status: Unknown
• Conditions: Stroke
• Intervention / Treatment: Device: G-EO System; Other: Conventional Physiotherapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Verona, Italy, 37134
    • Recruiting
    • University of Verona
    • Contact: Nicola Smania, MD, Prof; Phone Number: +39 0458124573; Email: nicola.smania@univr.it
  • Verona, Italy, 37134
    • Recruiting
    • UOC Neurorehabilitation
    • Contact: Nicola Smania, Professor; Phone Number: +390458124573; Email: nicola.smania@univr.it
    • Principal Investigator: Marialuisa Gandolfi, PhD
    • Sub-Investigator: Nicola Valè, PT
    • Sub-Investigator: Eleonora Dimitrova, PT
    • Sub-Investigator: Christian Geroin, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• First-ever ischemic or hemorrhagic stroke;
• More than or equal to 3 months post stroke;
• Age>18 years;
• Mini- Mental State Examination (MMSE) score more than 23;
• Ability to stand for at least 1 min without arm support; ability to walk independently for at least 10 m with or without walking aids;
• Functional Ambulation Category score equal or more than 1.
• Signed informed consent form

Exclusion Criteria:

• Severe cognitive or communicative disorders that hamper collaboration;
• Unstable cardiovascular system conditions (i.e. labile compensated cardiac insufficiency, angina pectoris), deep vein thrombosis, severe neurological or orthopedic diseases which massively affect lower limb mobility; severe joint misalignment;
• Treatment of lower limb spasticity (i.e. botulinum toxin) in the 3 months prior to the start of the study and/or during its execution.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robot-Assisted Stair Climbing Training; Each session will consist of the G-EO System training and stretching exercises. Total net treatment time/session: 50 minutes. Physiotherapists will alter constraints to grade tasks according to patient ability. The training complexity will be increased, as the patient will improve in performance (i.e. increasing gait speed, reducing body weight support, increasing the number of repetition). Heart rate during training sessions will be monitored using a Polar V800. Heart rate will not exceed the threshold of 120 bpm.	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.
Active Comparator: Conventional Physiotherapy; 50 min of overground walking training and stair climbing up/down and lower limb mobilization and stretching exercise.	Other: Conventional Physiotherapy; Overground walking training including real stair climbing up/down and lower limb mobilization and stretching exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time required to climb Up and Down 9 stairs (seconds)	(seconds)	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-Minute Walking Test evaluates walking endurance.	(meters)	1 day
The 10-Meter Walking Test evaluates gait speed.	(seconds)	1 day
The Berg Balance Scale evaluates standing balance during functional activities.	(score)	1 day
The Timed Up and Go test evaluates person's mobility.	(seconds)	1 day
The Modified Ashworth Scale evaluates muscle spasticity.	(score)	1 day
Fatigue Severity Scale	(score)	1 day
Number of steps performed with the Robot and without.	(number of steps)	1 day
Borg Scale	(score)	1 day
Functional Ambulation Category (FAC);	(score)	1 day
Dynamic Gait Index (DGI)	(score)	1 day
Barthel Index	(score)	1 day
European Stroke Scale	(score)	1 day
EMG gait	(phases of muscles activation)	1 day
Stabilometric assessment	(center of pressure parameters)	1 day
Blood pressure	mmg	1 day
heart beat	(number per minute)	1 day

Collaborators and Investigators

• Sponsor: Universita di Verona
• Collaborators: Marialuisa Gandolfi; Christian Geroin; Eleonora Dimitrova; Nicola Valè
• Investigators: Principal Investigator: Nicola Smania, MD, Prof, Universita di Verona

Publications and helpful links

General Publications

• Morone G, Paolucci S, Cherubini A, De Angelis D, Venturiero V, Coiro P, Iosa M. Robot-assisted gait training for stroke patients: current state of the art and perspectives of robotics. Neuropsychiatr Dis Treat. 2017 May 15;13:1303-1311. doi: 10.2147/NDT.S114102. eCollection 2017.
• Gandolfi M, Vale N, Dimitrova E, Zanolin ME, Mattiuz N, Battistuzzi E, Beccari M, Geroin C, Picelli A, Waldner A, Smania N. Robot-Assisted Stair Climbing Training on Postural Control and Sensory Integration Processes in Chronic Post-stroke Patients: A Randomized Controlled Clinical Trial. Front Neurosci. 2019 Oct 24;13:1143. doi: 10.3389/fnins.2019.01143. eCollection 2019.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Anticipated): November 1, 2018
• Study Completion (Anticipated): November 1, 2018

Study Registration Dates

• First Submitted: June 12, 2018
• First Submitted That Met QC Criteria: June 21, 2018
• First Posted (Actual): June 25, 2018

Study Record Updates

• Last Update Posted (Actual): June 25, 2018
• Last Update Submitted That Met QC Criteria: June 21, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Balance, Gait, Rehabilitation, Stroke, Robotics, Postural
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: STAIRs Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No