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Rehabilitation With and Without Robot and Allied Digital Technologies in Stroke Patients

ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione Don Carlo Gnocchi ETS

About this trial

Rehabilitation after stroke often employs Robot and Allied Digital Technologies (RADTs), yet evidence on their effectiveness remains inconclusive due to study heterogeneity and limited sample sizes.

This multicentre randomized controlled pragmatic trial aims at comprehensively and accurately assessing the effectiveness of rehabilitation mediated by RADTs after a stroke, compared to traditional rehabilitation, also considering economic sustainability.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

First-ever diagnosis of ischemic or haemorrhagic stroke confirmed by Computed Tomography or Magnetic Resonance Imaging;

Age 18 years and over;

Time since the event equal to or less than 6 months;

Mild to severe impairment of the upper limb (motor section of the Fugl-Meyer Assessment of Upper Extremity ≤ 58) and/or mild to severe impairment of the lower limb (score on the Functional Ambulation Categories scale ≤ 4) and/or mild to severe impairment of balance (Berg Balance Scale ≤ 45);

Disqualifiers

Clinical instability;

Behavioral/cognitive disorders preventing adequate patient compliance with both traditional and robotic rehabilitation treatment (severe cognitive deficit, Montreal Cognitive Assessment <10);

Rigidity or hypertonia (Modified Ashworth Scale > 3) in the plegic/paretic limb;

Serious uncorrectable visual impairments preventing the patient from performing treatment with technological and/or robotic devices;

Trial design

Design model

Parallel

Treatments tested in this trial

  • robotic rehabilitation

    Other intervention

    Treatment will occur in a gym equipped with devices for all the domains, with two physiotherapists supervising groups of 4 to 6 patients, depending on their clinical severity. Patients will undergo a total of 25 sessions, each lasting 45 minutes, with the following frequency: * 5 times a week for 5 weeks, for inpatients; * 3 times a week for 8.3 weeks, for outpatients.

  • traditional rehabilitation

    Other intervention

    A physiotherapist-to-patient ratio of 1:1 is provided for the treatment in all participating centres. Patients will undergo a total of 25 sessions, each lasting 45 minutes, with the following frequency: * 5 times a week for 5 weeks, for inpatients; * 3 times a week for 8.3 weeks, for outpatients.

Treatment groups

596 Participants
are divided into 2 treatment groups
Group A: Integrated Treatment with Robotic & Technological Devices (RADTs)Experimental treatment 1 intervention
Group B: Traditional TreatmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in the modified Barthel Index

The modified Barthel Index for Activities of Daily Living is a validated ordinal scale which measures a person's ability to complete activities of daily living (ADL). Scores range from 0 (total dependence) to 100 (total independence).

Time frame
baseline; within 24 hours from the 25th rehabilitation session

Secondary outcomes

1

Fugl-Meyer Assessment for the upper extremities - motor function

The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. The upper extremity motor function domain includes items assessing movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, and hand. It ranges from 0 (hemiplegia) to 66 (normal motor performance).

Time frame
baseline; within 24 hours from the 25th rehabilitation session
2

Fugl-Meyer Assessment for the upper extremities - sensory function

The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. The upper extremity sensory function domain evaluates light touch on two surfaces of the arm, and position sense for upper limb joints. It ranges from 0 to 12 (normal sensory function).

Time frame
baseline; within 24 hours from the 25th rehabilitation session
3

Fugl-Meyer Assessment for the lower extremities - motor function

The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. The lower extremity motor function domain includes items assessing movement, coordination, and reflex action of the hip, knee, and ankle. It ranges from 0 (hemiplegia) to 34 (normal motor performance).

Time frame
baseline; within 24 hours from the 25th rehabilitation session
4

Fugl-Meyer Assessment for the lower extremities - sensory function

The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. The lower extremity sensory function domain evaluates light touch on two surfaces of the leg, and position sense for lower limb joints. It ranges from 0 to 12 (normal sensory function).

Time frame
baseline; within 24 hours from the 25th rehabilitation session

Other outcomes

1

premorbid Modified Rankin Scale

The pre-stroke Modified Rankin Score (mRS) is an estimated score used to assess the patient's pre-stroke level of function. It has a grade ranging from 0 (no symptoms) to 6 (dead).

Time frame
At baseline
2

Life Time Physical Activity Questionnaire

The Life Time Physical Activity Questionnaire (LTPAQ) is an interviewer-administered questionnaire used to estimate a respondent's physical activity done from childhood to the present.

Time frame
At baseline
3

Cognitive Reserve Index

The Cognitive Reserve Index questionnaire (CRIq) aims to collect and estimate the amount of cognitive reserve acquired during a person's lifetime. In a single index (CRI), the questionnaire conveys three main sources of cognitive reserve: education, working activity, and leisure time activities. The CRIq score fell into 1 of 5 ordered levels: low (less than 70); medium-low (70-84); medium (85-114); medium-high (115-130); and high (more than 130).

Time frame
At baseline
4

National Institutes of Health Stroke Scale (NIHSS)

It is validated tool for assessing stroke severity. NIHSS scores range from 0 to 42, with higher scores indicating more severe neurological deficit.

Time frame
At baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione Don Carlo Gnocchi ETS

Lead sponsor

Istituti Clinici Scientifici Maugeri SpA

Collaborator

IRCCS National Neurological Institute "C. Mondino" Foundation

Collaborator

Ospedale Policlinico San Martino

Collaborator

Università di Pavia

Collaborator

Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna

Collaborator

Source ClinicalTrials.gov
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