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Completed

NCT Number: NCT03025126

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

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.

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Key information

Conditions

Rehabilitation Nervous System Diseases Technology Telerehabilitation

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale Valduce, Lecco, LC, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multimedial Rehabilitation

Other

Usual Care Program

Other

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

Primary outcomes

  1. 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

  2. Global cognitive state assessed on MONTREAL COGNITIVE ASSESSMENT (MOCA)

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

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

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

  4. 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

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

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

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

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

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

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

  4. Walking speed assessed on 10-Meter Walking Test (10MWT)

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

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

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

  6. Attention and concentration assessed on Attention and Concentration test

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

  7. Memory abilities assessed on Rivermead Behavioural Memory Test - 3 (RBMT3)

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

  8. Caregiver Need assessed on Caregiver Need Assessment (CNA) questionnaire

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

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Collaborators

  • Fondazione Opera S Camillo
  • Villa Beretta Rehabilitation Center

Registry information

Acronym: HEAD

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 19, 2017
Registry last updated
Feb 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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