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

Sponsor
Istituto Clinico Humanitas (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05393700
Collaborator
(none)
45
3
12

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Action Observation Therapy
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Early Sleep After Action Observation Therapy on Balance in Elderly
Anticipated Study Start Date :
Jun 15, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Jun 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: AOT-sleep

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

Behavioral: Action Observation Therapy
Action Observation Therapy implies the observation of video-clips representing motor tasks alone or followed by imagination and/or imitation of observed tasks.

Active Comparator: AOT-control

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

Behavioral: Action Observation Therapy
Action Observation Therapy implies the observation of video-clips representing motor tasks alone or followed by imagination and/or imitation of observed tasks.

Sham Comparator: Control

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

Behavioral: Action Observation Therapy
Action Observation Therapy implies the observation of video-clips representing motor tasks alone or followed by imagination and/or imitation of observed tasks.

Outcome Measures

Primary Outcome Measures

  1. Changes in Lower Quarter Y-Balance Test [At baseline, 3 weeks and 1 month after the training end]

    The outcome measure is aimed at investigating changes in terms of static balance

  2. Changes in 10-Meter Walking Test [At baseline, 3 weeks of training and 1 month after the training end]

    The outcome measure is aimed at investigating changes in terms of gait speed

  3. Changes in Timed Up and Go Test [At baseline, 3 weeks of training and 1 month after the training end]

    The outcome measure is aimed at investigating changes in terms of mobility

  4. Changes in Four Step Square Test [At baseline, 3 weeks of training and 1 month after the training end]

    The outcome measure is aimed at investigating changes in terms of dynamic balance

Secondary Outcome Measures

  1. Changes in center of pressure parameters [At baseline, 3 weeks of training and 1 month after the training end]

    The outcome measure is aimed at investigating changes in terms of postural stability

  2. Changes in Fall Efficacy Scale [At baseline, 3 weeks of training and 1 month after the training end]

    The outcome measure is aimed at investigating changes in terms of fear of falling

  3. Pittsburg Quality Sleep Index [3 weeks]

    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)

  4. Kinesthetic and Visual Imagery Questionnaire [At baseline]

    The outcome measure is aimed at investigating the imagination ability of participants. The scale range from 0 (worse score) to 50 (better score).

  5. Morningness Eveningness Scale [At baseline]

    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."

  6. Euro Quality of Life - 5 dimensions [At baseline]

    The outcome measure is aimed at investigating the quality of life of participants. The scale ranges from 0 (worse outcome) to 1 (better outcome).

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Istituto Clinico Humanitas

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Michele Tedeschi, Principal Investigator, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier:
NCT05393700
Other Study ID Numbers:
  • CLF22/01
First Posted:
May 26, 2022
Last Update Posted:
May 26, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 26, 2022