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Clinical Trials/NCT03025126
NCT03025126
Completed
Not Applicable

Human Empowerment Aging and Disability (HEAD): New Technologies for Neurorehabilitation

Fondazione Don Carlo Gnocchi Onlus3 sites in 1 country100 target enrollmentMarch 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rehabilitation
Sponsor
Fondazione Don Carlo Gnocchi Onlus
Enrollment
100
Locations
3
Primary Endpoint
Health-related quality of life assessed on the short-form 12-item Health Survey (SF-12) questionnaire
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2016
End Date
December 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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)

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: change from baseline after 4 months and after 7 months

Global cognitive state assessed on MONTREAL COGNITIVE ASSESSMENT (MOCA)

Time Frame: change from baseline after 4 months and after 7 months

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

Time Frame: change from baseline after 4 months and after 7 months

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

Time Frame: change from baseline after 4 months and after 7 months

Secondary Outcomes

  • Unilateral gross manual dexterity assessed on Box and Blocks Test (BBT)(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)
  • Attention and concentration assessed on Attention and Concentration test(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)
  • Static balance and fall risk assessed on Berg Balance Scale (BBS)(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)
  • Caregiver Need assessed on Caregiver Need Assessment (CNA) questionnaire(change from baseline after 4 months and after 7 months)
  • Memory abilities assessed on Rivermead Behavioural Memory Test - 3 (RBMT3)(change from baseline after 4 months and after 7 months)

Study Sites (3)

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