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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Old Age; Debility; Balance; Distorted
• Intervention / Treatment: Behavioral: Action Observation Therapy

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Lower Quarter Y-Balance Test	The outcome measure is aimed at investigating changes in terms of static balance	At baseline, 3 weeks and 1 month after the training end
Changes in 10-Meter Walking Test	The outcome measure is aimed at investigating changes in terms of gait speed	At baseline, 3 weeks of training and 1 month after the training end
Changes in Timed Up and Go Test	The outcome measure is aimed at investigating changes in terms of mobility	At baseline, 3 weeks of training and 1 month after the training end
Changes in Four Step Square Test	The outcome measure is aimed at investigating changes in terms of dynamic balance	At baseline, 3 weeks of training and 1 month after the training end

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in center of pressure parameters	The outcome measure is aimed at investigating changes in terms of postural stability	At baseline, 3 weeks of training and 1 month after the training end
Changes in Fall Efficacy Scale	The outcome measure is aimed at investigating changes in terms of fear of falling	At baseline, 3 weeks of training and 1 month after the training end
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)	3 weeks
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).	At baseline
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."	At baseline
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).	At baseline

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 15, 2022
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): June 15, 2023

Study Registration Dates

• First Submitted: May 20, 2022
• First Submitted That Met QC Criteria: May 25, 2022
• First Posted (ACTUAL): May 26, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 25, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: CLF22/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No