Telerehabilitation for Post-stroke Patients

NCT04413240 | Unknown

• 1 other identifier: Finalizzata RF-2016-02363044
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

In the last few years, there has been an increasing shift towards outpatients setting in the care of patients with stroke. Unfortunately, this led to a high percentage of discharged patients who did not receive an adequate amount of rehabilitation, because of some non-clinical factors, such as resource availability, geographical location, age, and personal wealth. To date, there is growing evidence about the role of telerehabilitation as an effective method to deliver rehabilitative treatments to homebound subjects with no moving of therapists or patients. However, the most appropriate organizational models regarding Health Technology Assessment in telerehabilitation procedures still object of debate. On these bases, the aim of this project is to investigate the feasibility and effectiveness of multi-domains telerehabilitation procedures in stroke patients in order to supply the National Health Service with some useful information about the use of telerehabilitation in clinical practice of stroke rehabilitation.

Conditions

Stroke Sequelae

Keywords

Healthcare organizations; Integrated care delivery systems; Cost-benefit analysis; Stroke; Pharmacoeconomics; Rehabilitation; Telerehabilitation; Healthcare organizations, programs, and delivery of services; Disease management and modeling

Outcome Measures

Primary Outcomes (3)

• Changes at the Fugl-Meyer Assessment score between the time frame

  The Fugl-Meyer Assessment allows quantifying the degree of post-stroke disability through the evaluation of the following 5 domains of interest. In the upper and lower limbs: the motor function; sensory function; the range of motion; joint pain. The last domain is balance control. The maximum possible score in the Fugl-Meyer scale is 226, which corresponds to full sensory-motor recovery.

  T0 (baseline) - T1 (4 weeks) - T2 (8 weeks)

• Changes at the Aachener Aphasia Test score between the time frame

  The Aachener Aphasia Test for the evaluation of aphasia is composed of 6 sections: spontaneous language, token test, repetition, written language (reading aloud, dictated by composition and dictated by handwriting), denomination (sentences, words, complex words) and oral and written comprehension. All items in the subtests repetition, written language, naming and comprehension are scored on a four-point scale, where 3 represents normal performance and 0 no response, preservation, automatism, or totally unrelated to the target.

  T0 (baseline) - T1 (4 weeks) - T2 (8 weeks)

• Changes at the Oxford Cognitive Screen score between the time frame

  The Oxford Cognitive Screen is a short and efficient cognitive screening tool that can be delivered at the bedside in acute stroke. OCS is easy to administer and score and importantly is inclusive for patients with aphasia and neglect. OCS returns a single, not divisible visual snapshot of a patient's cognitive profile, which at a glance demonstrates the specific cognitive domain impairments in Attention, Language, Praxis, Number and Memory.

  T0 (baseline) - T1 (4 weeks) - T2 (8 weeks)

Secondary Outcomes (7)

• Barthel Index (BI)

  T0 (baseline) - T1 (4 weeks) - T2 (8 weeks)

• Beck Depression Inventory scale (BDI-scale)

  T0 (baseline) - T1 (4 weeks) - T2 (8 weeks)

• Short-Form-36 (SF-36)

  T0 (baseline) - T1 (4 weeks) - T2 (8 weeks)

• Perceived Disease Impact Scale (PDIS)

  T0 (baseline) - T1 (4 weeks) - T2 (8 weeks)

• Caregiver Burden Inventory

  T0 (baseline) - T1 (4 weeks) - T2 (8 weeks)

Study Arms (2)

Telerehabilitation group

EXPERIMENTAL

Patients in this group will undergo 20 sessions (1 hour a day, 5 days a week for 4 consecutive weeks) of "multidomain" telerehabilitation (motor, speech and/or cognitive) with VRRS, K-Wand and Khymu connected to a workstation (Telecockpit).

Device: Telerehabilitation

Conventional rehabilitation group

ACTIVE COMPARATOR

The patients assigned to this group will undergo 20 sessions (1 hour a day, 5 days a week for 4 consecutive weeks) of "multidomain" rehabilitation (motor, speech and/or cognitive). It is not possible a priori to precisely define the instruments that will be used during rehabilitation management. The telerehabilitation or conventional treatment methods (type of therapeutic exercise, modality of cognitive stimulation and/or taking care of speech therapy) will be determined for each patient on the basis of the needs emerging from the physiatric examination performed at T0, defined according to the Individual Rehabilitation Project and applied according to each Rehabilitation Program (motor, cognitive and/or speech therapy) periodically updated.

Other: Conventional rehabilitation

Interventions

Telerehabilitation DEVICE

* VRRS is a medical device to perform cognitive telerehabilitation and home speech therapy in online or offline mode. * K-Wand is an additional device to VRRS for motor telerehabilitation of the upper limb and trunk. It works with a set of motion sensors through light recognition technology. * Khymu is a set of sensors added to the VRRS used to carry out motor telerehabilitation activities of the lower limb. The use in combination with the K-Wand is able to allow "full-body" motor telerehabilitation. Patients will have at their home a special workstation connected to the internet. The same equipment will also be present in the reference structure. Only the online telerehabilitation mode will be used, including an audio and video teleconference. The rehabilitator will be able to remotely control the patient's system. The patient, will see on his screen the exercises to be performed, their realization and the results achieved.

Telerehabilitation group

Conventional rehabilitation OTHER

It is not possible a priori to precisely define the instruments that will be used during rehabilitation management. The telerehabilitation or conventional treatment methods (type of therapeutic exercise, modality of cognitive stimulation and/or taking care of speech therapy) will be determined for each patient on the basis of the needs emerging from the physiatric examination performed at T0, defined according to the Individual Rehabilitation Project and applied according to each Rehabilitation Program (motor, cognitive and/or speech therapy) periodically updated.

Conventional rehabilitation group

Eligibility Criteria

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

You may qualify if:

• first diagnosis of ischemic brain stroke documented radiologically by brain CT or MRI;
• aphasia documented at the Aachener Aphasia Test (AAT) and/or presence of cognitive deficits documented at the neuropsychological assessment with the Oxford Cognitive Screen (OCS).
• availability of ADSL or higher internet connection at home
• ability of the subject and/or caregiver to understand and use the telerehabilitation system
• signature of informed consent

You may not qualify if:

• contemporary participation in other clinical studies;
• cognitive impairment defined as a Montreal Cognitive Assessment (MoCA) score \<26;
• bone deformities as a consequence of previous traumatic events in the 4 limbs;
• contractures fixed to the 4 limbs assessed as 4/4 on the modified Ashworth scale (MAS);
• other neurological and orthopaedic diseases interfering with the study.
• Particularly vulnerable populations. The following cannot be included in the study:
• patients with judicial interdiction
• patients with supportive administration
• institutionalized patients
• Criteria for the ongoing exit from the study
• Relapse of disease during the study period
• Withdrawal of informed consent to participate in the study
• Impossibility to carry out the rehabilitation treatment or the assessments required by the study protocol according to the defined schedule.

Sponsors & Collaborators

• Universita di Verona: lead
• IRCCS San Camillo, Venezia, Italy: collaborator
• Istituto Superiore di Sanità: collaborator

Study Sites (1)

Section of Clinical Neurology, Department Neurological, Neuropsychological, Morphological and Movement Sciences, University of Verona, Verona, Italy

Verona, 37124, Italy

RECRUITING

Related Publications (1)

• Piron L, Turolla A, Agostini M, Zucconi C, Cortese F, Zampolini M, Zannini M, Dam M, Ventura L, Battauz M, Tonin P. Exercises for paretic upper limb after stroke: a combined virtual-reality and telemedicine approach. J Rehabil Med. 2009 Nov;41(12):1016-102. doi: 10.2340/16501977-0459.

  PMID: 19841835 RESULT

MeSH Terms

Conditions

Stroke

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Nicola Smania, MD

  Universita di Verona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicola Smania, MD

CONTACT

045 8124573; nicola.smania@univr.it

Alessandro Picelli, PhD

CONTACT

045 8124573; alessandro.picelli@univr.it

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: Chief of the Neurorehabilitation Unit. Full Professor.

Model Details: A clinical study with medical device, multicenter, single-blind, randomized controlled trial.

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 2, 2020
• Study Start: July 1, 2020
• Primary Completion: May 1, 2023
• Study Completion: August 1, 2023
• Last Updated: May 23, 2022

Record last verified: 2022-05

Locations

IT (1)