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

Study Overview
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Brief Summary
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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.

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

Conditions
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Old Age; Debility, Balance; Distorted

Intervention / Treatment
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* Behavioral: Action Observation Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AOT-sleep<br>They will be asked to watch video-clips representing motor contents before sleeping. | Behavioral: Action Observation Therapy<br>* Action Observation Therapy implies the observation of video-clips representing motor tasks alone or followed by imagination and/or imitation of observed tasks.<br>|
| Active Comparator: AOT-control<br>They will be asked to watch video-clips representing motor contents at least 12 hours before sleeping. | Behavioral: Action Observation Therapy<br>* Action Observation Therapy implies the observation of video-clips representing motor tasks alone or followed by imagination and/or imitation of observed tasks.<br>|
| Sham Comparator: Control<br>They will be asked to watch video-clips representing landscapes before sleeping. | Behavioral: Action Observation Therapy<br>* Action Observation Therapy implies the observation of video-clips representing motor tasks alone or followed by imagination and/or imitation of observed tasks.<br>|

What is the study measuring?
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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 |