Back to resultsRobot-Assisted Stair Climbing Training (RASCT)
Primary Purpose
Stroke
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
G-EO System
Conventional Physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Balance, Gait, Rehabilitation, Stroke, Robotics, Postural
Eligibility Criteria
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.
Sites / Locations
- University of VeronaRecruiting
- UOC NeurorehabilitationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Robot-Assisted Stair Climbing Training
Conventional Physiotherapy
Arm 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.
50 min of overground walking training and stair climbing up/down and lower limb mobilization and stretching exercise.
Outcomes
Primary Outcome Measures
The time required to climb Up and Down 9 stairs (seconds)
(seconds)
Secondary Outcome Measures
6-Minute Walking Test evaluates walking endurance.
(meters)
The 10-Meter Walking Test evaluates gait speed.
(seconds)
The Berg Balance Scale evaluates standing balance during functional activities.
(score)
The Timed Up and Go test evaluates person's mobility.
(seconds)
The Modified Ashworth Scale evaluates muscle spasticity.
(score)
Fatigue Severity Scale
(score)
Number of steps performed with the Robot and without.
(number of steps)
Borg Scale
(score)
Functional Ambulation Category (FAC);
(score)
Dynamic Gait Index (DGI)
(score)
Barthel Index
(score)
European Stroke Scale
(score)
EMG gait
(phases of muscles activation)
Stabilometric assessment
(center of pressure parameters)
Blood pressure
mmg
heart beat
(number per minute)
Full Information
NCT ID
NCT03566901
First Posted
June 12, 2018
Last Updated
June 21, 2018
Sponsor
Universita di Verona
Collaborators
Marialuisa Gandolfi, Christian Geroin, Eleonora Dimitrova, Nicola Valè
1. Study Identification
Unique Protocol Identification Number
NCT03566901
Brief Title
Robot-Assisted Stair Climbing Training
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
November 1, 2018 (Anticipated)
Study Completion Date
November 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universita di Verona
Collaborators
Marialuisa Gandolfi, Christian Geroin, Eleonora Dimitrova, Nicola Valè
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Balance, Gait, Rehabilitation, Stroke, Robotics, Postural
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Robot-Assisted Stair Climbing Training
Arm Type
Experimental
Arm 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.
Arm Title
Conventional Physiotherapy
Arm Type
Active Comparator
Arm Description
50 min of overground walking training and stair climbing up/down and lower limb mobilization and stretching exercise.
Intervention Type
Device
Intervention Name(s)
G-EO System
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Physiotherapy
Intervention Description
Overground walking training including real stair climbing up/down and lower limb mobilization and stretching exercises.
Primary Outcome Measure Information:
Title
The time required to climb Up and Down 9 stairs (seconds)
Description
(seconds)
Time Frame
1 day
Secondary Outcome Measure Information:
Title
6-Minute Walking Test evaluates walking endurance.
Description
(meters)
Time Frame
1 day
Title
The 10-Meter Walking Test evaluates gait speed.
Description
(seconds)
Time Frame
1 day
Title
The Berg Balance Scale evaluates standing balance during functional activities.
Description
(score)
Time Frame
1 day
Title
The Timed Up and Go test evaluates person's mobility.
Description
(seconds)
Time Frame
1 day
Title
The Modified Ashworth Scale evaluates muscle spasticity.
Description
(score)
Time Frame
1 day
Title
Fatigue Severity Scale
Description
(score)
Time Frame
1 day
Title
Number of steps performed with the Robot and without.
Description
(number of steps)
Time Frame
1 day
Title
Borg Scale
Description
(score)
Time Frame
1 day
Title
Functional Ambulation Category (FAC);
Description
(score)
Time Frame
1 day
Title
Dynamic Gait Index (DGI)
Description
(score)
Time Frame
1 day
Title
Barthel Index
Description
(score)
Time Frame
1 day
Title
European Stroke Scale
Description
(score)
Time Frame
1 day
Title
EMG gait
Description
(phases of muscles activation)
Time Frame
1 day
Title
Stabilometric assessment
Description
(center of pressure parameters)
Time Frame
1 day
Title
Blood pressure
Description
mmg
Time Frame
1 day
Title
heart beat
Description
(number per minute)
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicola Smania, MD, Prof
Phone
0458124573
Ext
+39
Email
nicola.smania@univr.it
First Name & Middle Initial & Last Name or Official Title & Degree
Marialuisa Gandolfi, MD, PhD
Phone
0458124573
Ext
+39
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicola Smania, MD, Prof
Organizational Affiliation
Universita di Verona
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Verona
City
Verona
ZIP/Postal Code
37134
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicola Smania, MD, Prof
Phone
0458124573
Ext
+39
Email
nicola.smania@univr.it
Facility Name
UOC Neurorehabilitation
City
Verona
ZIP/Postal Code
37134
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicola Smania, Professor
Phone
+390458124573
Email
nicola.smania@univr.it
First Name & Middle Initial & Last Name & Degree
Marialuisa Gandolfi, PhD
First Name & Middle Initial & Last Name & Degree
Nicola Valè, PT
First Name & Middle Initial & Last Name & Degree
Eleonora Dimitrova, PT
First Name & Middle Initial & Last Name & Degree
Christian Geroin, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28553117
Citation
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.
Results Reference
result
PubMed Identifier
31708735
Citation
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.
Results Reference
derived
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Robot-Assisted Stair Climbing Training
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