Clinical trial NCT03566901: Robot-Assisted Stair Climbing Training
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
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Balance, Gait, Rehabilitation, Stroke, Robotics, Postural
Lead sponsor: Universita di Verona
Sponsor class: OTHER
Collaborators: name: Marialuisa Gandolfi
name: Christian Geroin
name: Eleonora Dimitrova
name: Nicola Valè
First posted: 2018-06-25
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The time required to climb Up and Down 9 stairs (seconds)
timeFrame: 1 day
Secondary outcomes:
measure: 6-Minute Walking Test evaluates walking endurance.
timeFrame: 1 day
measure: The 10-Meter Walking Test evaluates gait speed.
timeFrame: 1 day
measure: The Berg Balance Scale evaluates standing balance during functional activities.
timeFrame: 1 day
measure: The Timed Up and Go test evaluates person's mobility.
timeFrame: 1 day
measure: The Modified Ashworth Scale evaluates muscle spasticity.
timeFrame: 1 day
measure: Fatigue Severity Scale
timeFrame: 1 day
measure: Number of steps performed with the Robot and without.
timeFrame: 1 day
measure: Borg Scale
timeFrame: 1 day
measure: Functional Ambulation Category (FAC);
timeFrame: 1 day
measure: Dynamic Gait Index (DGI)
timeFrame: 1 day
measure: Barthel Index
timeFrame: 1 day
measure: European Stroke Scale
timeFrame: 1 day
measure: EMG gait
timeFrame: 1 day
measure: Stabilometric assessment
timeFrame: 1 day
measure: Blood pressure
timeFrame: 1 day
measure: heart beat
timeFrame: 1 day
Other outcomes:
Locations:
city: Verona
country: Italy
facility: University of Verona
city: Verona
country: Italy
facility: UOC Neurorehabilitation
Study officials:
affiliation: Universita di Verona
name: Nicola Smania, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.