Technological Devices and Home Automation System in Neurological Rehabilitation

NCT06270420 | Recruiting DMC

• 1 other identifier: 2022.04
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The use of home automation system may be useful in rehabilitation to collect data about the environment and the amount of therapy. Then, the data may be stored in a cloud and integrated with data collected during training provided by technological devices. The main goal of this longitudinal pilot study is to define the productivity of the rehabilitation room (i.e., HoSmartAI room) in the IRCCS San Camillo Hospital (Venice, Italy) service, where the investigators will install home automation sensors and treat patients with neurological disease using technological devices (e.g., robotic and virtual reality). The secondary goals are to define the patients' satisfaction, usability of the system and the clinical effect of treatments delivered with technological devices in the HoSmartAI room. The patient will be assessed to personalized the treatment based on their needs. The treatment will consist of 15 sessions (1h/day, 5day/week, 3 weeks). At the end of the study, the patients will be assessed to define any clinical improvements. Finally, the investigators will define the characteristics of the patients who will benefit from the rehabilitation provided in the HoSmartAI room.

Conditions

Neurological Disease; Motor Disorders

Keywords

Home Automation; Sensorized environment; Organizational model; Neurological rehabilitation; Technological Innovation; Motor Recovery

Outcome Measures

Primary Outcomes (5)

• Key performance indicator (KPI) of the room - Number of treatments

  Number of treatments that are provided inside the HoSmartAI room.

  Every month up to 1 year

• Key performance indicator (KPI) ot the room - Number of sessions

  Number of sessions that are provided inside the HoSmartAI room.

  Every month up to 1 year

• Room Key performance indicator (KPI) of the room - Number of minutes of therapy

  Number of minutes of therapy that are provided inside the HoSmartAI room.

  Every month up to 1 year

• Key performance indicator (KPI) of the room - Number of physiotherapists involved

  Number of physiotherapists involved inside the HoSmartAI room.

  Every month up to 1 year

• Key performance indicator (KPI) of the room - Number of adverse events

  Number of adverse events detected in the HoSmartAI room.

  Every month up to 1 year

Secondary Outcomes (12)

• Box and Blocks Test

  Change from Baseline Box and Blocks Test at 3 weeks

• Reaching Performance Scale

  Change from Baseline Reaching Performance Scale at 3 weeks

• Nine Hole Pegboard Test

  Change from Baseline Nine Hole Pegboard Test at 3 weeks

• Berg balance scale (BBS)

  Change from Baseline BBS at 3 weeks

• 10 Meter Walk Test (10MWT)

  Change from Baseline 10MWT at 3 weeks

Study Arms (1)

HosmartAI training

EXPERIMENTAL

HosmartAI training will consist of motor training provided by technological devices (i.e. OAK, VRRS, AMADEO, PABLO) in the HoSmartAI room.

Device: Technological Motor Rehabilitation

Interventions

Technological Motor Rehabilitation DEVICE

Patients will undergo to motor treatment in the HoSmartAI room using one of the technological devices (i.e. OAK, VRRS Evo by Khymeia Group, Padova, Italy; AMADEO, PABLO by Tyromotion GmbH, Gratz, Austria), for the upper limb and lower limb motor recovery, balance and manual dexterity recovery. The duration of the treatment will be 15 sessions, 1 hour each, with daily frequency, 5 days a week, for a total of 3 weeks.

HosmartAI training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (\> 18 yy)
• Diagnosis of neurological disease (e.g. ischemic and/or hemorrhagic stroke, Parkinson's, multiple sclerosis, brain trauma, peripheral neuropathy)

You may not qualify if:

• Fractures
• Major depressive disorder
• Severe visual and/or hearing impairments
• Dementia
• Non-pharmacologically controlled epilepsy
• Severe neglect
• Severe comprehension deficit

Sponsors & Collaborators

• IRCCS San Camillo, Venezia, Italy: lead

Study Sites (1)

IRCCS San Camillo Hospital

Venice-Lido, Venice, 30126, Italy

RECRUITING

Related Publications (6)

• Molteni F, Gasperini G, Cannaviello G, Guanziroli E. Exoskeleton and End-Effector Robots for Upper and Lower Limbs Rehabilitation: Narrative Review. PM R. 2018 Sep;10(9 Suppl 2):S174-S188. doi: 10.1016/j.pmrj.2018.06.005.

  PMID: 30269804 BACKGROUND

• Orihuela-Espina F, Roldan GF, Sanchez-Villavicencio I, Palafox L, Leder R, Sucar LE, Hernandez-Franco J. Robot training for hand motor recovery in subacute stroke patients: A randomized controlled trial. J Hand Ther. 2016 Jan-Mar;29(1):51-7; quiz 57. doi: 10.1016/j.jht.2015.11.006. Epub 2015 Nov 26.

  PMID: 26847320 BACKGROUND

• Latella D, Maggio MG, Maresca G, Andaloro A, Anchesi S, Pajno V, De Luca R, Di Lorenzo G, Manuli A, Calabro RS. Effects of domotics on cognitive, social and personal functioning in patients with Parkinson's disease: A pilot study. Assist Technol. 2022 Jul 4;34(4):423-428. doi: 10.1080/10400435.2020.1846095. Epub 2021 Apr 6.

  PMID: 33337294 BACKGROUND

• Maggio MG, Maresca G, Russo M, Stagnitti MC, Anchesi S, Casella C, Zichitella C, Manuli A, De Cola MC, De Luca R, Calabro RS. Effects of domotics on cognitive, social and personal functioning in patients with chronic stroke: A pilot study. Disabil Health J. 2020 Jan;13(1):100838. doi: 10.1016/j.dhjo.2019.100838. Epub 2019 Sep 4.

  PMID: 31501039 BACKGROUND

• Wolbring G, Lashewicz B. Home care technology through an ability expectation lens. J Med Internet Res. 2014 Jun 20;16(6):e155. doi: 10.2196/jmir.3135.

  PMID: 24956581 BACKGROUND

• Cleland J, Hutchinson C, Williams PAH, Manuel K, Laver K. A scoping review to explore the health, social and economic outcomes of home automation for people with disability. Disabil Rehabil Assist Technol. 2024 May;19(4):1446-1453. doi: 10.1080/17483107.2023.2196308. Epub 2023 Apr 3.

  PMID: 37012673 BACKGROUND

Related Links

• The link of the Pilot #3 refers to the HoSmartAI projects

MeSH Terms

Conditions

Nervous System Diseases; Motor Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Giorgia Pregnolato

  IRCCS San Camillo Hospital

  STUDY CHAIR

Central Study Contacts

Giorgia Pregnolato

CONTACT

+39 0412207; giorgia.pregnolato@hsancamillo.it

Valeria Campanini

CONTACT

+39 0412207; valeria.campanini@hsancamillo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Longitudinal Pilot study

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 21, 2024
• Study Start: February 5, 2023
• Primary Completion: March 31, 2024
• Study Completion: May 30, 2024
• Last Updated: February 21, 2024

Record last verified: 2024-02

Locations

IT (1)