- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03709875
Telerehabilitation in Severe Acquired Brain Injury
October 17, 2018 updated by: Rocco Salvatore Calabrò, IRCCS Centro Neurolesi "Bonino-Pulejo"
A Cost-effective Analysis of Telerehabilitation in Patients With Severe Acquired Brain Injury
We will investigate the use of TR, based on advanced Information and Communication Technology (ICT) solutions, taking into account that the supervision of rehabilitation at home will be enriched with the counselling and vital parameters monitoring.
The aim of the study is to evaluate that TR is at least non-inferior in comparison with the same amount of usual territorial rehabilitative physical treatments (UTRT), taking into account patients' functional recovery, psychological well-being, caregiver burden, and healthcare costs.
The enrolled patients will be balanced for pathology and randomized in two groups, performing TR (G1) or standard rehabilitation training (G2), respectively, according to a pc-generated random assignment.TR will be delivered by means of an advanced video-conferencing system, whereas the patient will be provided with low-cost monitoring devices, able to collect data about his/her health status and QoL.
In both the groups each treatment (either cognitive or motor, or both as per patient functional status) will last about one hour a day, five days/week, for 12 weeks.
Two structured telephone interviews will be administered to the patients (when possible) and/or their caregivers, and to all the healthcare professionals involved in the patient management, one week after the beginning and at the end of the TR.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Messina, Italy, 98123
- IRCCS Centro Neurolesi Bonino-Pulejo"
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:age range 18 to 65 years; diagnosis of SABI; availability at home internet connection.
Exclusion Criteria: severe cognitive and behavioral impairments, cardio-respiratory instability or other medical illness potentially interfering with the treatment, severe limb spasticity, high-risk of spontaneous fracture, substance abuse.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TR Treatment
TR will be delivered by means of an advanced video-conferencing system, and patients will be provided with low-cost monitoring devices, able to collect data about the health status and QoL.
All treatments from remote are based on scheduled videoconferences between the patient's home and the Clinical Units, and therapists can control and modify the exercises.
A virtual reality based system, consisting of two PC-based workstations, located at the patient's home and at the rehabilitation center, will be used.
For the motor treatments the patient has to move the real end effector, following the trajectory of the corresponding virtual task displayed on his computer screen.
The speech and cognitive exercises will be delivered from the two Research Institutes to the patient's home.
|
A virtual reality based system, consisting of two PC-based workstations, located at the patient's home and at the rehabilitation center, will be used.
For the motor treatments the patient has to move the real end effector, following the trajectory of the corresponding virtual task displayed on his computer screen.
The speech (mainly lexical based) and cognitive (attention focused) exercises will be delivered from the two Research Institutes to the patient's home.
During the treatment at home, the patients will use wearable monitoring devices to monitor their status (speed, heart rate, respiratory rate, training load and single-lead ECG in real-time) and to provide real-time feedback during exercises.
|
Other: Conventional Treatment
In this group patients will be treated with conventional physiotherapy and speech training, adjusted in reason of the clinical needs, as usually.
Treatments for motor limbs activity will be focused on functional active-assistive and active exercises.
Conventional "paper and pencil" training will be used to improve cognitive function.
|
A virtual reality based system, consisting of two PC-based workstations, located at the patient's home and at the rehabilitation center, will be used.
For the motor treatments the patient has to move the real end effector, following the trajectory of the corresponding virtual task displayed on his computer screen.
The speech (mainly lexical based) and cognitive (attention focused) exercises will be delivered from the two Research Institutes to the patient's home.
During the treatment at home, the patients will use wearable monitoring devices to monitor their status (speed, heart rate, respiratory rate, training load and single-lead ECG in real-time) and to provide real-time feedback during exercises.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
WHO Disability Assessment schedule
Time Frame: 3 months
|
This generic assessment instrument for health and disability may be considered a tool to produce standardized disability levels and profiles.
It is applicable across cultures, in all adult populations, and is directly linked at the level of the concepts to the International Classification of Functioning, Disability and Health (ICF).
|
3 months
|
Montreal Cognitive assessment
Time Frame: 3 months
|
he Montreal Cognitive Assessment (MoCA) is a widely used screening assessment for detecting cognitive impairment.he
MoCA test is a one-page 30-point test administered in approximately 10 minutes.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fugl- Meyer for Upper limb
Time Frame: 3 months
|
The Fugl-Meyer Upper Extremity (FMUE) Scale1 is a widely used and highly recommended stroke-specific, performance-based measure of impairment.
It is designed to assess reflex activity, movement control and muscle strength in the upper extremity of people with post-stroke hemiplegia.
It has been extensively used as an outcome measure in rehabilitation trials and to record post-stroke recovery.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Rocco S Calabrò, PhD, IRCCS Centro Neurolesi
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
November 26, 2018
Primary Completion (Anticipated)
May 27, 2019
Study Completion (Anticipated)
December 28, 2020
Study Registration Dates
First Submitted
October 15, 2018
First Submitted That Met QC Criteria
October 15, 2018
First Posted (Actual)
October 17, 2018
Study Record Updates
Last Update Posted (Actual)
October 18, 2018
Last Update Submitted That Met QC Criteria
October 17, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08/2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stroke
-
Moleac Pte Ltd.RecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, CryptogenicSingapore, Philippines
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
Vanderbilt University Medical CenterPatient-Centered Outcomes Research Institute; University of Alabama at BirminghamActive, not recruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Engagement, Patient | Stroke HemorrhagicUnited States
-
University of Illinois at ChicagoRecruitingStroke, Ischemic | Stroke Hemorrhagic | Stroke, CerebrovascularUnited States
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
-
University of MinnesotaAmerican Occupational Therapy FoundationActive, not recruitingStroke | Stroke Sequelae | Stroke Hemorrhagic | Stroke IschemicUnited States
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Michael Smith Foundation for...RecruitingStroke | Stroke, Ischemic | Stroke Hemorrhagic | Chronic StrokeCanada
-
University of CincinnatiMedical University of South Carolina; University of California, Los Angeles; University...RecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke HemorrhagicUnited States
-
Turkish Stroke Research and Clinical Trials NetworkElectroCore INC; Turkish Neurological SocietyCompletedStroke | Stroke, Ischemic | Stroke, Acute | Stroke, HemorrhagicTurkey
Clinical Trials on TR Treatment
-
Region ZealandZealand University Hospital; Copenhagen Trial Unit, Center for Clinical Intervention... and other collaboratorsCompletedADHD | Attention Deficit Hyperactivity DisorderDenmark
-
University of California, San DiegoNational Eating Disorders AssociationEnrolling by invitation
-
Czech Technical University in PragueUniversity Hospital, MotolRecruitingNeonatal Respiratory Distress | Very Low Birth Weight InfantCzechia
-
University of ThessalyCompletedBody Composition | Physical Fitness | Energy Expenditure | Resting Metabolic RateGreece
-
University of ThessalyCompletedBody Composition | Physical Fitness | Energy Expenditure | Resting Metabolic RateGreece
-
Medical University of South CarolinaCompleted
-
University Medical Center GroningenCompletedCardiac CatheterisationNetherlands
-
VA Office of Research and DevelopmentRecruitingSuicide | Interpersonal RelationsUnited States
-
Terumo Medical CorporationMedical University of South CarolinaCompleted
-
Hacettepe UniversityUnknown