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

Balance; Distorted Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05393700
• Other study ID #: CLF22/01
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2022
• Est. completion date: June 15, 2023

Study information

• Verified date: May 2022
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: June 15, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Balance; Distorted
• Frailty
• Old Age; Debility

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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