Stroke
Conditions
Keywords
Balance, Gait, Rehabilitation, Stroke, Robotics, Postural
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.
Interventions
DEVICEG-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.
OTHERConventional Physiotherapy
Overground walking training including real stair climbing up/down and lower limb mobilization and stretching exercises.
Sponsors
Marialuisa Gandolfi
Christian Geroin
Eleonora Dimitrova
Nicola Valè
Universita di Verona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
A multisite single blind randomized controlled trial involving the 3 clinical sites (Verona, Bolzano, Monza) will be performed, according to the CONSORT Statement (www.consort-statement.org). The PIs will be responsible for the randomization procedures. If eligible, patients will be randomly allocated (allocation ratio 1:1) to the experimental (EG) or conventional physiotherapy (CP) using computer-generated random numbers (www.randomization.com). In each site, one examiner blinded to group assignment will be responsible for assessments. Prior to the start of the study the EG and CP protocols will be designed. To ensure uniformity in the delivery of treatments, one therapist from each center will be taught to training protocols by the research collaborators. Participants will receive 50-min, individual treatment sessions as outpatients 2 days a week for 5 consecutive weeks, for a total of 10 sessions. For each Unit one physiotherapist will be assigned to the EG and one to the CP.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The time required to climb Up and Down 9 stairs (seconds) | 1 day | (seconds) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The 10-Meter Walking Test evaluates gait speed. | 1 day | (seconds) |
| The Berg Balance Scale evaluates standing balance during functional activities. | 1 day | (score) |
| The Timed Up and Go test evaluates person's mobility. | 1 day | (seconds) |
| The Modified Ashworth Scale evaluates muscle spasticity. | 1 day | (score) |
| Fatigue Severity Scale | 1 day | (score) |
| Number of steps performed with the Robot and without. | 1 day | (number of steps) |
| Borg Scale | 1 day | (score) |
| 6-Minute Walking Test evaluates walking endurance. | 1 day | (meters) |
| Dynamic Gait Index (DGI) | 1 day | (score) |
| Barthel Index | 1 day | (score) |
| European Stroke Scale | 1 day | (score) |
| EMG gait | 1 day | (phases of muscles activation) |
| Stabilometric assessment | 1 day | (center of pressure parameters) |
| Blood pressure | 1 day | mmg |
| heart beat | 1 day | (number per minute) |
| Functional Ambulation Category (FAC); | 1 day | (score) |
Countries
Italy
Contacts
Primary ContactNicola Smania, MD, Prof
Backup ContactMarialuisa Gandolfi, MD, PhD
Outcome results
None listed