Brain InjuriesNCT03709875
Telerehabilitation in Severe Acquired Brain Injury
A study testing TR Treatment in people with Brain Injuries and Stroke, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Brain Injuries, Stroke
- What is being tested?
- TR Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 26 Nov 2018to 28 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Brain Injuries, Stroke
- Being tested
- TR Treatment
- Keywords
- Telerehabilitation, Motor outcomes, Cognitive dysfunction
- Medical subject headings
- Brain Injuries, Stroke, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TR TreatmentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| TR Treatment | Experimental | 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. Receives: Device: TR Treatment |
| Conventional Treatment | Other | 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. Receives: Device: TR Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months
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.
Measured: 3 months
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start26 Nov 2018 (estimated)
- Primary completion27 May 2019 (estimated)
- Study completion28 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multi-center, prospective, parallel design, single-blind trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro Neurolesi Bonino Pulejo
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS San Camillo, Venezia, Italy, University of Messina
- Responsible party
- Principal investigator, Rocco Salvatore Calabrò, IRCCS Centro Neurolesi Bonino Pulejo
- Investigators
- Rocco S Calabrò, PhD, Principal investigator, IRCCS Centro Neurolesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03709875
- Sponsor's protocol ID
- 08/2018
- Status last verified
- Oct 2018
- First submitted
- 15 Oct 2018
- Last updated
- 18 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Calabro RS, Bonanno M, Torregrossa W, Cacciante L, Celesti A, Rifici C, Tonin P, De Luca R, Quartarone A. Benefits of Telerehabilitation for Patients With Severe Acquired Brain Injury: Promising Results From a Multicenter Randomized Controlled Trial Using Nonimmersive Virtual Reality. J Med Internet Res. 2023 Aug 21;25:e45458. doi: 10.2196/45458.
PubMed 37490017
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cost-effective Analysis of Telerehabilitation in Patients With Severe Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT03709875
- Acronym / sponsor ID
- 08/2018
- Conditions
- Brain Injuries, Stroke
- Keywords
- Telerehabilitation, Motor outcomes, Cognitive dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- IRCCS Centro Neurolesi Bonino PulejoUniversity, hospital or other
- Collaborators
- IRCCS San Camillo, Venezia, Italy, University of Messina
- Study start
- 26 Nov 2018 (estimated)
- Primary completion
- 27 May 2019 (estimated)
- Study completion
- 28 Dec 2020 (estimated)
- First posted
- 17 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- multi-center, prospective, parallel design, single-blind trial
| Arm | Type | Receives |
|---|---|---|
| TR Treatment | Experimental | Device: TR TreatmentTR 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. |
| Conventional Treatment | Other | Device: TR TreatmentIn 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TR TreatmentA 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. | Device | Conventional Treatment, TR Treatment |
Primary outcome
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).
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.
1 secondary outcome
Fugl- Meyer for Upper limb
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
- Derived from this study: PubMed 37490017Calabro RS, Bonanno M, Torregrossa W, Cacciante L, Celesti A, Rifici C, Tonin P, De Luca R, Quartarone A. Benefits of Telerehabilitation for Patients With Severe Acquired Brain Injury: Promising Results From a Multicenter Randomized Controlled Trial Using Nonimmersive Virtual Reality. J Med Internet Res. 2023 Aug 21;25:e45458. doi: 10.2196/45458.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rocco S Calabrò, PhD principal investigator
IRCCS Centro Neurolesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TR Treatment in people with Brain Injuries and Stroke, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rocco S Calabrò, MD, PhD (+3909060128166, salbro77@tiscali.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WHO Disability Assessment schedule (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03709875, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2018.