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StrokeRASCTNCT03566901

Robot-Assisted Stair Climbing Training

A study testing G-EO System and Conventional Physiotherapy in people with Stroke, run by Universita di Verona at 2 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
G-EO System and Conventional Physiotherapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
2 sitesItaly
Study dates
1 Oct 2017to 1 Nov 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Nicola Smania, MD, Prof contact

0458124573 ext. +39

nicola.smania@univr.it

Marialuisa Gandolfi, MD, PhD contact

0458124573 ext. +39

Italy2 sites, 2 recruiting

  • University of Verona

    Verona, 37134

    Nicola Smania, MD, Prof, 0458124573 ext. +39, nicola.smania@univr.it

    Recruiting

  • UOC Neurorehabilitation

    Verona, 37134

    Nicola Smania, Professor, +390458124573, nicola.smania@univr.it

    Marialuisa Gandolfi, PhD

    Recruiting

Other trials in Italy

About this study

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

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.

Read the 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.

Conditions
Stroke
Being tested
G-EO System, Conventional Physiotherapy
Keywords
Balance, Gait, Rehabilitation, Stroke, Robotics, Postural
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • G-EO SystemDevice

    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.

  • Conventional PhysiotherapyOther

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

Study groups in NCT03566901
Study groupRoleWhat they receive
Robot-Assisted Stair Climbing TrainingExperimentalEach 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.
Receives: Device: G-EO System
Conventional PhysiotherapyActive comparator50 min of overground walking training and stair climbing up/down and lower limb mobilization and stretching exercise.
Receives: Other: Conventional Physiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    (seconds)

    Measured: 1 day

Secondary outcomes (16)

  1. 6-Minute Walking Test evaluates walking endurance.

    (meters)

    Measured: 1 day

  2. The 10-Meter Walking Test evaluates gait speed.

    (seconds)

    Measured: 1 day

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

    (score)

    Measured: 1 day

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

    (seconds)

    Measured: 1 day

  5. The Modified Ashworth Scale evaluates muscle spasticity.

    (score)

    Measured: 1 day

  6. Fatigue Severity Scale

    (score)

    Measured: 1 day

  7. Number of steps performed with the Robot and without.

    (number of steps)

    Measured: 1 day

  8. Borg Scale

    (score)

    Measured: 1 day

  9. Functional Ambulation Category (FAC);

    (score)

    Measured: 1 day

  10. Dynamic Gait Index (DGI)

    (score)

    Measured: 1 day

  11. Barthel Index

    (score)

    Measured: 1 day

  12. European Stroke Scale

    (score)

    Measured: 1 day

  13. EMG gait

    (phases of muscles activation)

    Measured: 1 day

  14. Stabilometric assessment

    (center of pressure parameters)

    Measured: 1 day

  15. Blood pressure

    mmg

    Measured: 1 day

  16. heart beat

    (number per minute)

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2018
  2. Study start1 Oct 2017
  3. Primary completion1 Nov 2018 (estimated)
  4. Study completion1 Nov 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Single blind
Who is masked
Outcomes assessor
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03566901
Sponsor's protocol ID
STAIRs Trial
Acronym
RASCT
Status last verified
Jun 2018
First submitted
12 Jun 2018
Last updated
25 Jun 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 28553117

  • 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.

    PubMed 31708735

Questions about this trial

What is this clinical trial studying?

A study testing G-EO System and Conventional Physiotherapy in people with Stroke, run by Universita di Verona at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nicola Smania, MD, Prof (0458124573 ext. +39, nicola.smania@univr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The time required to climb Up and Down 9 stairs (seconds) (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03566901, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2018.

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