Robot-Assisted Stair Climbing Training
- Conditions
- Stroke
- Interventions
- Device: G-EO SystemOther: Conventional Physiotherapy
- Registration Number
- NCT03566901
- Lead Sponsor
- Universita di Verona
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 72
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Robot-Assisted Stair Climbing Training G-EO System 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. Conventional Physiotherapy Conventional Physiotherapy 50 min of overground walking training and stair climbing up/down and lower limb mobilization and stretching exercise.
- Primary Outcome Measures
Name Time Method The time required to climb Up and Down 9 stairs (seconds) 1 day (seconds)
- Secondary Outcome Measures
Name Time Method The Timed Up and Go test evaluates person's mobility. 1 day (seconds)
The Modified Ashworth Scale evaluates muscle spasticity. 1 day (score)
Borg Scale 1 day (score)
Stabilometric assessment 1 day (center of pressure parameters)
The Berg Balance Scale evaluates standing balance during functional activities. 1 day (score)
Barthel Index 1 day (score)
Dynamic Gait Index (DGI) 1 day (score)
European Stroke Scale 1 day (score)
Blood pressure 1 day mmg
The 10-Meter Walking Test evaluates gait speed. 1 day (seconds)
6-Minute Walking Test evaluates walking endurance. 1 day (meters)
Fatigue Severity Scale 1 day (score)
EMG gait 1 day (phases of muscles activation)
Functional Ambulation Category (FAC); 1 day (score)
Number of steps performed with the Robot and without. 1 day (number of steps)
heart beat 1 day (number per minute)
Trial Locations
- Locations (2)
University of Verona
🇮🇹Verona, Italy
UOC Neurorehabilitation
🇮🇹Verona, Italy