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Effects of Early Sleep After Action Observation Therapy on Balance in Elderly

Primary Purpose

Old Age; Debility, Balance; Distorted

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Action Observation Therapy
Sponsored by
Istituto Clinico Humanitas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Old Age; Debility

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Ability to walk for at least 100 meters with no assistance or aids

Exclusion Criteria:

  • Musculoskeletal disorders able to affect balance
  • Traumas and/or injuries and/or surgery at the level of the lower limbs, spine in the previous year
  • Sleep disorders
  • Drugs able to affect sleep
  • Dementia or cognitive decline (MCI)
  • Psychiatric or neurological disorders

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Sham Comparator

    Arm Label

    AOT-sleep

    AOT-control

    Control

    Arm Description

    They will be asked to watch video-clips representing motor contents before sleeping.

    They will be asked to watch video-clips representing motor contents at least 12 hours before sleeping.

    They will be asked to watch video-clips representing landscapes before sleeping.

    Outcomes

    Primary Outcome Measures

    Changes in Lower Quarter Y-Balance Test
    The outcome measure is aimed at investigating changes in terms of static balance
    Changes in 10-Meter Walking Test
    The outcome measure is aimed at investigating changes in terms of gait speed
    Changes in Timed Up and Go Test
    The outcome measure is aimed at investigating changes in terms of mobility
    Changes in Four Step Square Test
    The outcome measure is aimed at investigating changes in terms of dynamic balance

    Secondary Outcome Measures

    Changes in center of pressure parameters
    The outcome measure is aimed at investigating changes in terms of postural stability
    Changes in Fall Efficacy Scale
    The outcome measure is aimed at investigating changes in terms of fear of falling
    Pittsburg Quality Sleep Index
    The outcome measure is aimed at investigating the sleep quality in the training period. The scale ranges from 0 (better outcome) to 21 points (worse outcome)
    Kinesthetic and Visual Imagery Questionnaire
    The outcome measure is aimed at investigating the imagination ability of participants. The scale range from 0 (worse score) to 50 (better score).
    Morningness Eveningness Scale
    The outcome measure is aimed at investigating the chronotype of participants. The score ranges from 16 to 86 points. A score lower than 41 points indicates "evening types.", scores of 59 and above indicate "morning types", while scores between 42-58 indicate "intermediate types."
    Euro Quality of Life - 5 dimensions
    The outcome measure is aimed at investigating the quality of life of participants. The scale ranges from 0 (worse outcome) to 1 (better outcome).

    Full Information

    First Posted
    May 20, 2022
    Last Updated
    May 25, 2022
    Sponsor
    Istituto Clinico Humanitas
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05393700
    Brief Title
    Effects of Early Sleep After Action Observation Therapy on Balance in Elderly
    Official Title
    Effects of Early Sleep After Action Observation Therapy on Balance in Elderly
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 15, 2022 (Anticipated)
    Primary Completion Date
    December 31, 2022 (Anticipated)
    Study Completion Date
    June 15, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istituto Clinico Humanitas

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study aims at investigating the effects of an early sleep window after Action Observation Therapy (AOT) on balance in elderly. Forty-five healthy-like elderly will be enrolled and randomized into 3 groups (AOT-sleep, AOT-control and Control) performing a 3-week AOT. AOT-sleep and AOT-control will be asked to watch video-clips showing motor contents before sleeping or at least 12 hours before sleeping, respectively, whereas Control will be asked to watch landascape video-clips before sleeping. Participants will be assessed before and after training and at 1 month follow-up for balance outcomes.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Old Age; Debility, Balance; Distorted

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    45 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    AOT-sleep
    Arm Type
    Experimental
    Arm Description
    They will be asked to watch video-clips representing motor contents before sleeping.
    Arm Title
    AOT-control
    Arm Type
    Active Comparator
    Arm Description
    They will be asked to watch video-clips representing motor contents at least 12 hours before sleeping.
    Arm Title
    Control
    Arm Type
    Sham Comparator
    Arm Description
    They will be asked to watch video-clips representing landscapes before sleeping.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Action Observation Therapy
    Intervention Description
    Action Observation Therapy implies the observation of video-clips representing motor tasks alone or followed by imagination and/or imitation of observed tasks.
    Primary Outcome Measure Information:
    Title
    Changes in Lower Quarter Y-Balance Test
    Description
    The outcome measure is aimed at investigating changes in terms of static balance
    Time Frame
    At baseline, 3 weeks and 1 month after the training end
    Title
    Changes in 10-Meter Walking Test
    Description
    The outcome measure is aimed at investigating changes in terms of gait speed
    Time Frame
    At baseline, 3 weeks of training and 1 month after the training end
    Title
    Changes in Timed Up and Go Test
    Description
    The outcome measure is aimed at investigating changes in terms of mobility
    Time Frame
    At baseline, 3 weeks of training and 1 month after the training end
    Title
    Changes in Four Step Square Test
    Description
    The outcome measure is aimed at investigating changes in terms of dynamic balance
    Time Frame
    At baseline, 3 weeks of training and 1 month after the training end
    Secondary Outcome Measure Information:
    Title
    Changes in center of pressure parameters
    Description
    The outcome measure is aimed at investigating changes in terms of postural stability
    Time Frame
    At baseline, 3 weeks of training and 1 month after the training end
    Title
    Changes in Fall Efficacy Scale
    Description
    The outcome measure is aimed at investigating changes in terms of fear of falling
    Time Frame
    At baseline, 3 weeks of training and 1 month after the training end
    Title
    Pittsburg Quality Sleep Index
    Description
    The outcome measure is aimed at investigating the sleep quality in the training period. The scale ranges from 0 (better outcome) to 21 points (worse outcome)
    Time Frame
    3 weeks
    Title
    Kinesthetic and Visual Imagery Questionnaire
    Description
    The outcome measure is aimed at investigating the imagination ability of participants. The scale range from 0 (worse score) to 50 (better score).
    Time Frame
    At baseline
    Title
    Morningness Eveningness Scale
    Description
    The outcome measure is aimed at investigating the chronotype of participants. The score ranges from 16 to 86 points. A score lower than 41 points indicates "evening types.", scores of 59 and above indicate "morning types", while scores between 42-58 indicate "intermediate types."
    Time Frame
    At baseline
    Title
    Euro Quality of Life - 5 dimensions
    Description
    The outcome measure is aimed at investigating the quality of life of participants. The scale ranges from 0 (worse outcome) to 1 (better outcome).
    Time Frame
    At baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Ability to walk for at least 100 meters with no assistance or aids Exclusion Criteria: Musculoskeletal disorders able to affect balance Traumas and/or injuries and/or surgery at the level of the lower limbs, spine in the previous year Sleep disorders Drugs able to affect sleep Dementia or cognitive decline (MCI) Psychiatric or neurological disorders

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effects of Early Sleep After Action Observation Therapy on Balance in Elderly

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