Parkinson DiseaseARCTRANNCT06032468
ARC Intellicare for Telerehabilitation
A study testing ARC Intellicare and Rehabilitation sheets in people with Parkinson Disease and Multiple Sclerosis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
In the last 5 years, the available literature evidence has indicated that, in terms of clinical efficacy, telerehabilitation can give comparable results compared to face-to-face rehabilitation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Parkinson Disease, Multiple Sclerosis, Stroke
- What is being tested?
- ARC Intellicare and Rehabilitation sheets
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 9 Jan 2023to 31 Dec 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with diagnosis of Parkinson's disease with Hoehn\&Yahr staging 1-3
- diagnosis of multiple sclerosis with extended disability scale score 3.5-6
- diagnosis of ischemic stroke in the past 12 months
Who cannot join
- history of falls
- dementia
- epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ARC Intellicare for Telerehabilitation in Neurological Patients
In the last 5 years, the available literature evidence has indicated that, in terms of clinical efficacy, telerehabilitation can give comparable results compared to face-to-face rehabilitation. Studies of post-stroke patients have revealed some benefits of telerehabilitation, such as the ability for patients to self-record pain, mood and activity. Telerehabilitation has comparable efficacy to face-to-face rehabilitation for the recovery of some abilities, such as motor function, Activities of Daily Living (ADL), and independence; it is less effective, however, for the recovery of balance control. Published reviews concerning, in particular, neurological/neurodegenerative diseases show that telerehabilitation systems are effective in maintaining and/or improving some motor aspects, such as balance and gait, and non-motor aspects, such as mood and quality of life; they also increase patient satisfaction, so in the long term they appear to be beneficial, convenient and satisfying for patients and operators.
ARC Intellicare is a device undergoing certification as a Class I Medical Device (DM), already clinically tested during two uncontrolled clinical feasibility studies: ARCANGEL study (post-stroke, ClinicalTrials.gov Identifier: NCT03787433) and RICOMINCIARE study (post-COVID19 and Parkinson's disease, ClinicalTrials.gov Identifier: NCT05074771).
- Conditions
- Parkinson Disease, Multiple Sclerosis, Stroke
- Being tested
- ARC Intellicare, Rehabilitation sheets
- Medical subject headings
- Parkinson Disease, Multiple Sclerosis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARC IntellicareDevice
wearable devices to guide rehabilitation exercise
Rehabilitation sheetsOther
rehabilitation exercise sheets to guide rehabilitation exercise
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation with ARC Intellicare Device | Experimental | rehabilitation exercise for 8 weeks using wearable devices Receives: Device: ARC Intellicare |
| Rehabilitation with exercise sheet | Active comparator | rehabilitation exercise for 8 weeks using rehabilitation exercise sheets Receives: Other: Rehabilitation sheets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy outcome: Six minutes walking test (6MWT)
number of meters walked in brisk 6 minutes walk
Measured: 8 weeks
Efficacy outcome: Borg scale
score 0-20 of perceived effort during a motor task (higher scores mean a better or worse outcome)
Measured: 8 weeks
safety outcome: adverse event frequency
number of adverse events reported
Measured: 8 weeks
Usability outcome: adherence to prescription
percent of rehabilitation sessions completed
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start9 Jan 2023
- Primary completion30 Sep 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Early feasibility study
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06032468
- Sponsor's protocol ID
- 5135
- Acronym
- ARCTRAN
- Status last verified
- May 2023
- First submitted
- 12 May 2023
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARC Intellicare for Telerehabilitation in Neurological Patients
- ClinicalTrials.gov ID
- NCT06032468
- Acronym / sponsor ID
- ARCTRAN / 5135
- Conditions
- Parkinson Disease, Multiple Sclerosis, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 13 Sep 2023 (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.
In the last 5 years, the available literature evidence has indicated that, in terms of clinical efficacy, telerehabilitation can give comparable results compared to face-to-face rehabilitation. Studies of post-stroke patients have revealed some benefits of telerehabilitation, such as the ability for patients to self-record pain, mood and activity. Telerehabilitation has comparable efficacy to face-to-face rehabilitation for the recovery of some abilities, such as motor function, Activities of Daily Living (ADL), and independence; it is less effective, however, for the recovery of balance control. Published reviews concerning, in particular, neurological/neurodegenerative diseases show that telerehabilitation systems are effective in maintaining and/or improving some motor aspects, such as balance and gait, and non-motor aspects, such as mood and quality of life; they also increase patient satisfaction, so in the long term they appear to be beneficial, convenient and satisfying for patients and operators.
ARC Intellicare is a device undergoing certification as a Class I Medical Device (DM), already clinically tested during two uncontrolled clinical feasibility studies: ARCANGEL study (post-stroke, ClinicalTrials.gov Identifier: NCT03787433) and RICOMINCIARE study (post-COVID19 and Parkinson's disease, ClinicalTrials.gov Identifier: NCT05074771).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Early feasibility study
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation with ARC Intellicare Device | Experimental | Device: ARC Intellicarerehabilitation exercise for 8 weeks using wearable devices |
| Rehabilitation with exercise sheet | Active comparator | Other: Rehabilitation sheetsrehabilitation exercise for 8 weeks using rehabilitation exercise sheets |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with diagnosis of Parkinson's disease with Hoehn\&Yahr staging 1-3
- diagnosis of multiple sclerosis with extended disability scale score 3.5-6
- diagnosis of ischemic stroke in the past 12 months
Key exclusion criteria (3 listed)
- history of falls
- dementia
- epilepsy
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 |
|---|---|---|
| ARC Intellicarewearable devices to guide rehabilitation exercise | Device | Rehabilitation with ARC Intellicare Device |
| Rehabilitation sheetsrehabilitation exercise sheets to guide rehabilitation exercise | Other | Rehabilitation with exercise sheet |
Primary outcome
Efficacy outcome: Six minutes walking test (6MWT)
Time frame: 8 weeks
number of meters walked in brisk 6 minutes walk
Efficacy outcome: Borg scale
Time frame: 8 weeks
score 0-20 of perceived effort during a motor task (higher scores mean a better or worse outcome)
safety outcome: adverse event frequency
Time frame: 8 weeks
number of adverse events reported
Usability outcome: adherence to prescription
Time frame: 8 weeks
percent of rehabilitation sessions completed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARC Intellicare and Rehabilitation sheets in people with Parkinson Disease and Multiple Sclerosis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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?
The sponsor lists 3 inclusion and 3 exclusion criteria. 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: finished, as of the sponsor's last update on 13 Mar 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy outcome: Six minutes walking test (6MWT) (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2024.