Robot-Assisted Stair Climbing Training (RASCT)

University of Verona

Status: Unknown

Conditions: Stroke

Treatments: Device: G-EO System; Other: Conventional Physiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03566901

STAIRs Trial

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 2 patient groups

Robot-Assisted Stair Climbing Training

Experimental group

Description:

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.

Treatment:

Device: G-EO System

Conventional Physiotherapy

Active Comparator group

Description:

50 min of overground walking training and stair climbing up/down and lower limb mobilization and stretching exercise.

Treatment:

Other: Conventional Physiotherapy