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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05393700
Enrollment
45
Registered
2022-05-26
Start date
2022-06-15
Completion date
2023-06-15
Last updated
2022-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Balance; Distorted, Old Age; Debility

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.

Interventions

BEHAVIORALAction 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.

Sponsors

Istituto Clinico Humanitas
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to 85 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Changes in 10-Meter Walking TestAt baseline, 3 weeks of training and 1 month after the training endThe outcome measure is aimed at investigating changes in terms of gait speed
Changes in Timed Up and Go TestAt baseline, 3 weeks of training and 1 month after the training endThe outcome measure is aimed at investigating changes in terms of mobility
Changes in Four Step Square TestAt baseline, 3 weeks of training and 1 month after the training endThe outcome measure is aimed at investigating changes in terms of dynamic balance
Changes in Lower Quarter Y-Balance TestAt baseline, 3 weeks and 1 month after the training endThe outcome measure is aimed at investigating changes in terms of static balance

Secondary

MeasureTime frameDescription
Changes in center of pressure parametersAt baseline, 3 weeks of training and 1 month after the training endThe outcome measure is aimed at investigating changes in terms of postural stability
Changes in Fall Efficacy ScaleAt baseline, 3 weeks of training and 1 month after the training endThe outcome measure is aimed at investigating changes in terms of fear of falling
Pittsburg Quality Sleep Index3 weeksThe 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)
Kinesthetic and Visual Imagery QuestionnaireAt baselineThe outcome measure is aimed at investigating the imagination ability of participants. The scale range from 0 (worse score) to 50 (better score).
Morningness Eveningness ScaleAt baselineThe 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.
Euro Quality of Life - 5 dimensionsAt baselineThe outcome measure is aimed at investigating the quality of life of participants. The scale ranges from 0 (worse outcome) to 1 (better outcome).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026