Robot-Assisted Stair Climbing Training

Stroke Clinical Trial

— RASCT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03566901
• Other study ID #: STAIRs Trial
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: November 1, 2018

Study information

• Verified date: June 2018
• Source: Universita di Verona
• Contact: Nicola Smania, MD, Prof
• Phone: 0458124573
• Email: nicola.smania[@]univr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: November 1, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
Italy	University of Verona	Verona
Italy	UOC Neurorehabilitation	Verona

Sponsors (5)

Lead Sponsor	Collaborator
Universita di Verona	Christian Geroin, Eleonora Dimitrova, Marialuisa Gandolfi, Nicola Valè

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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.S — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The time required to climb Up and Down 9 stairs (seconds)	(seconds)	1 day
Secondary	6-Minute Walking Test evaluates walking endurance.	(meters)	1 day
Secondary	The 10-Meter Walking Test evaluates gait speed.	(seconds)	1 day
Secondary	The Berg Balance Scale evaluates standing balance during functional activities.	(score)	1 day
Secondary	The Timed Up and Go test evaluates person's mobility.	(seconds)	1 day
Secondary	The Modified Ashworth Scale evaluates muscle spasticity.	(score)	1 day
Secondary	Fatigue Severity Scale	(score)	1 day
Secondary	Number of steps performed with the Robot and without.	(number of steps)	1 day
Secondary	Borg Scale	(score)	1 day
Secondary	Functional Ambulation Category (FAC);	(score)	1 day
Secondary	Dynamic Gait Index (DGI)	(score)	1 day
Secondary	Barthel Index	(score)	1 day
Secondary	European Stroke Scale	(score)	1 day
Secondary	EMG gait	(phases of muscles activation)	1 day
Secondary	Stabilometric assessment	(center of pressure parameters)	1 day
Secondary	Blood pressure	mmg	1 day
Secondary	heart beat	(number per minute)	1 day