NCT03025126

Brief Summary

Congenital or acquired neurological disorders could lead to consistent motor and cognitive disabilities. The continuity and persistency of a tailored home rehabilitation protocol after recovery is crucial to prevent disease aggravation or relapses. The integration of a web-based new technology in home rehabilitation programme can constitute a functional low cost resource by offering patients off-line (and on-line) monitoring and by proposing new motivating ways of rehabilitation through high tech tools such as serious games.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 19, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 19, 2018

Status Verified

January 1, 2018

Enrollment Period

1.4 years

First QC Date

January 12, 2017

Last Update Submit

February 16, 2018

Conditions

RehabilitationTechnologyTelerehabilitationNervous System Diseases

Outcome Measures

Primary Outcomes (4)

  • Health-related quality of life assessed on the short-form 12-item Health Survey (SF-12) questionnaire

    change from baseline after 4 months and after 7 months

  • Global cognitive state assessed on MONTREAL COGNITIVE ASSESSMENT (MOCA)

    change from baseline after 4 months and after 7 months

  • Endurance assessed on two-minute walking test (2MWT)

    change from baseline after 4 months and after 7 months

  • Positive and negative affective state assessed on Positive and Negative Affect Scale (PANAS)

    change from baseline after 4 months and after 7 months

Secondary Outcomes (8)

  • Static balance and fall risk assessed on Berg Balance Scale (BBS)

    change from baseline after 4 months and after 7 months

  • Finger dexterity assessed on 9-Hole Peg Test (9HPT)

    change from baseline after 4 months and after 7 months

  • Unilateral gross manual dexterity assessed on Box and Blocks Test (BBT)

    change from baseline after 4 months and after 7 months

  • Walking speed assessed on 10-Meter Walking Test (10MWT)

    change from baseline after 4 months and after 7 months

  • Strength in upper and lower extremities assessed on Motricity Index (MI)

    change from baseline after 4 months and after 7 months

  • +3 more secondary outcomes

Study Arms (2)

HEAD Rehabilitation

EXPERIMENTAL

rehabilitation with IT multimedial devices

Other: Multimedial Rehabilitation

Usual care program

ACTIVE COMPARATOR

usual care program

Other: Usual care program

Interventions

Multimedial RehabilitationOTHER
HEAD Rehabilitation
Usual care programOTHER

Usual care at home program according to healthcare professional's advice

Usual care program

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age range 18-85
  • Parkinson Disease (PD - mild to moderate) in stable treatment for at least 3 months
  • Multiple Sclerosis (MS) without relapses in the last 3 months (EDSS ≤ 6)
  • post stroke ( ≥ 6 months after the acute event)

You may not qualify if:

  • Mini Mental State Examination \< 20
  • limited range of motion
  • severe pain
  • severe deficit of visual acuity or auditory perception or communication and severe dysmetry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Ospedale Valduce

Lecco, LC, 23845, Italy

Location

Presidio Sanitario S Camillo

Torino, TO, 10131, Italy

Location

Fondazione Don Carlo Gnocchi ONLUS

Milan, 20148, Italy

Location

Related Publications (1)

  • Jonsdottir J, Baglio F, Gindri P, Isernia S, Castiglioni C, Gramigna C, Palumbo G, Pagliari C, Di Tella S, Perini G, Bowman T, Salza M, Molteni F. Virtual Reality for Motor and Cognitive Rehabilitation From Clinic to Home: A Pilot Feasibility and Efficacy Study for Persons With Chronic Stroke. Front Neurol. 2021 Apr 7;12:601131. doi: 10.3389/fneur.2021.601131. eCollection 2021.

    PMID: 33897579DERIVED

MeSH Terms

Conditions

Nervous System Diseases

Study Officials

  • Franco Molteni, MD

    Valduce Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2017

First Posted

January 19, 2017

Study Start

March 1, 2016

Primary Completion

August 1, 2017

Study Completion

December 1, 2017

Last Updated

February 19, 2018

Record last verified: 2018-01

Locations

IT(3)