Robot-Assisted Stair Climbing Training

NCT03566901 | Unknown DMC

• 1 other identifier: STAIRs Trial
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke

Keywords

Balance, Gait, Rehabilitation, Stroke, Robotics, Postural

Outcome Measures

Primary Outcomes (1)

• The time required to climb Up and Down 9 stairs (seconds)

  (seconds)

  1 day

Secondary Outcomes (16)

• 6-Minute Walking Test evaluates walking endurance.

  1 day

• The 10-Meter Walking Test evaluates gait speed.

  1 day

• The Berg Balance Scale evaluates standing balance during functional activities.

  1 day

• The Timed Up and Go test evaluates person's mobility.

  1 day

• The Modified Ashworth Scale evaluates muscle spasticity.

  1 day

Study Arms (2)

Robot-Assisted Stair Climbing Training

EXPERIMENTAL

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.

Device: G-EO System

Conventional Physiotherapy

ACTIVE COMPARATOR

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

Other: Conventional Physiotherapy

Interventions

G-EO System DEVICE

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.

Robot-Assisted Stair Climbing Training

Conventional Physiotherapy OTHER

Overground walking training including real stair climbing up/down and lower limb mobilization and stretching exercises.

Conventional Physiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universita di Verona: lead
• Marialuisa Gandolfi: collaborator
• Christian Geroin: collaborator
• Eleonora Dimitrova: collaborator
• Nicola Valè: collaborator

Study Sites (2)

University of Verona

Verona, 37134, Italy

RECRUITING

UOC Neurorehabilitation

Verona, 37134, Italy

RECRUITING

Related Publications (2)

• 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.

  PMID: 28553117 RESULT

• 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.

  PMID: 31708735 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Nicola Smania, MD, Prof

  Universita di Verona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicola Smania, MD, Prof

CONTACT

0458124573; nicola.smania@univr.it

Marialuisa Gandolfi, MD, PhD

CONTACT

0458124573

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Rehabilitation Medicine

Model Details: 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.

Study Record Dates

• First Submitted: June 12, 2018
• First Posted: June 25, 2018
• Study Start: October 1, 2017
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: June 25, 2018

Record last verified: 2018-06

Locations

IT (2)