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

May 25, 2022 updated by: Michele Tedeschi, Istituto Clinico Humanitas
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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in Lower Quarter Y-Balance Test
Time Frame: At baseline, 3 weeks and 1 month after the training end
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
Time Frame: At baseline, 3 weeks of training and 1 month after the training end
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
Time Frame: At baseline, 3 weeks of training and 1 month after the training end
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
Time Frame: At baseline, 3 weeks of training and 1 month after the training end
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in center of pressure parameters
Time Frame: At baseline, 3 weeks of training and 1 month after the training end
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
Time Frame: At baseline, 3 weeks of training and 1 month after the training end
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
Time Frame: 3 weeks
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
Time Frame: At baseline
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
Time Frame: At baseline
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
Time Frame: At baseline
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istituto Clinico Humanitas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 26, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 26, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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