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Telerehabilitation With Digital Technologies for the Continuum of Care of Stroke Patients

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

About this trial

The goal of the pragmatic study is to evaluate the effectiveness of a home-based telerehabilitation protocol for patients with post-stroke disabilities, compared to a home-based educational program.

The main question it aims to answer is:

Is home-based neuromotor and cognitive rehabilitation using digital tools more effective than a traditional educational program for improving static and dynamic balance in patients with subacute and chronic stroke? Researchers will compare the outcome (Berg Balance Scale) measured at baseline with the outcome after treatment to test its effectiveness.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of first ischemic or hemorrhagic stroke verified by Computed Axial Tomography or MRI.

Age greater than 18 years.

Latency since the event: a) greater than 3 months and less than or equal to 6 months; b) greater than 6 months and less than 24 months.

Ability to perform the Timed Up and Go Test.

Disqualifiers

Unstable clinical conditions.

Behavioral/cognitive disorders that prevent adequate patient compliance with the study (severe cognitive impairment, Montreal Cognitive Assessment<17.5).

Severe visual impairment that cannot be corrected by lenses, preventing the patient from performing treatment with digital instruments.

Refusal to sign informed consent.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Integrated Treatment with Digital Tools

    Other intervention

    Patients will undergo a 6-week remote telerehabilitation program. The recommended frequency of treatment is a minimum of 3 sessions per week, but patients may adjust the schedule in agreement with their assigned therapist. If a patient is unable to complete at least 18 sessions due to clinical reasons, they will be considered as a dropout. Moreover, one session per week will be conducted synchronously, with the therapist remotely supervising the patient's activities in real time, while the remaining sessions will be asynchronous, allowing the patient to complete the exercises independently.

  • Home-Based Educational Program

    Other intervention

    Patients will be monitored over a six-week period through weekly phone calls to assess their progress and overall condition. Additionally, participants are required to maintain an activity diary to document their engagement with the prescribed activities.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Treatment with Digital ToolsExperimental treatment 1 intervention
Group B: Educational ProgramActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in the Berg Balance Scale (BBS)

The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.

Time frame
Baseline; within 7 days after the end of the 6-week observation/rehabilitation period

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 7 days after the end of the 6-week observation/rehabilitation period
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 7 days after the end of the 6-week observation/rehabilitation period
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 7 days after the end of the 6-week observation/rehabilitation period
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 7 days after the end of the 6-week observation/rehabilitation period

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
Baseline
2

Montreal Cognitive Assessment Scale

The Montreal Cognitive Assessment (MoCA) is a widely used screening assessment for detecting cognitive impairment. It ranges from 0 (worst) to 30 (best).

Time frame
Baseline
3

Timed Up and Go

The Timed Up and Go (TUG) test is a simple and widely used assessment to evaluate mobility, balance, walking ability, and fall risk.The test measures the time (in seconds) it takes for a person to: (i) Stand up from a standard chair (seat height \~46 cm); (ii) Walk 3 meters (10 feet) forward at a comfortable pace; (iii) Turn around at the 3-meter mark; (iv) Walk back to the chair; (v) Sit down again. The total time taken is recorded, with specific cut-off values indicating different levels of mobility impairment and fall risk.

Time frame
Baseline
4

Computer skills questionnaire

It is an ad-hoc questionnaire to assess computer skills. It collects information regarding personal competencies in the use of technology, with items rated on a 5-point scale (1 to 5) to evaluate both the level of knowledge and the frequency of technology use. The questionnaire also includes general information questions about computer skills, assessed using a dichotomous (yes/no) scale.

Time frame
Baseline

Sponsors and contacts

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Fondazione Don Carlo Gnocchi Onlus

Lead sponsor

Istituti Clinici Scientifici Maugeri SpA

Collaborator

IRCCS National Neurological Institute "C. Mondino" Foundation

Collaborator

Ospedale Policlinico San Martino

Collaborator

C.O.T. Cure Ortopediche Traumatologiche S.p.A.

Collaborator

Università di Pavia

Collaborator

Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna

Collaborator

Campus Bio-Medico University

Collaborator

Source ClinicalTrials.gov
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