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Telerehabilitation in Severe Acquired Brain Injury

Primary Purpose

Brain Injuries, Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
TR Treatment
Sponsored by
IRCCS Centro Neurolesi "Bonino-Pulejo"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Injuries focused on measuring Telerehabilitation, Motor outcomes, Cognitive dysfunction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • IRCCS Centro Neurolesi Bonino-Pulejo"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

TR Treatment

Conventional Treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

WHO Disability Assessment schedule
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).
Montreal Cognitive assessment
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.

Secondary Outcome Measures

Fugl- Meyer for Upper limb
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.

Full Information

First Posted
October 15, 2018
Last Updated
October 17, 2018
Sponsor
IRCCS Centro Neurolesi "Bonino-Pulejo"
Collaborators
IRCCS San Camillo, Venezia, Italy, University of Messina
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1. Study Identification

Unique Protocol Identification Number
NCT03709875
Brief Title
Telerehabilitation in Severe Acquired Brain Injury
Official Title
A Cost-effective Analysis of Telerehabilitation in Patients With Severe Acquired Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 26, 2018 (Anticipated)
Primary Completion Date
May 27, 2019 (Anticipated)
Study Completion Date
December 28, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Centro Neurolesi "Bonino-Pulejo"
Collaborators
IRCCS San Camillo, Venezia, Italy, University of Messina

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries, Stroke
Keywords
Telerehabilitation, Motor outcomes, Cognitive dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
multi-center, prospective, parallel design, single-blind trial
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TR Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional Treatment
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
TR Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
WHO Disability Assessment schedule
Description
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).
Time Frame
3 months
Title
Montreal Cognitive assessment
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Fugl- Meyer for Upper limb
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rocco S Calabrò, MD, PhD
Phone
+3909060128166
Email
salbro77@tiscali.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rocco S Calabrò, PhD
Organizational Affiliation
IRCCS Centro Neurolesi
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS Centro Neurolesi Bonino-Pulejo"
City
Messina
ZIP/Postal Code
98123
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Telerehabilitation in Severe Acquired Brain Injury

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