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

NCT05393700 | Unknown

• 1 other identifier: CLF22/01
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Old Age; Debility; Balance; Distorted

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Changes in center of pressure parameters

  At baseline, 3 weeks of training and 1 month after the training end

• Changes in Fall Efficacy Scale

  At baseline, 3 weeks of training and 1 month after the training end

• Pittsburg Quality Sleep Index

  3 weeks

• Kinesthetic and Visual Imagery Questionnaire

  At baseline

• Morningness Eveningness Scale

  At baseline

Study Arms (3)

AOT-sleep

EXPERIMENTAL

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

Behavioral: Action Observation Therapy

AOT-control

ACTIVE COMPARATOR

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

Behavioral: Action Observation Therapy

Control

SHAM COMPARATOR

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

Behavioral: Action Observation Therapy

Interventions

Action Observation Therapy BEHAVIORAL

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

AOT-control; AOT-sleep; Control

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: May 26, 2022
• Study Start: June 15, 2022
• Primary Completion: December 31, 2022
• Study Completion: June 15, 2023
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share