Old Age; DebilityNCT05393700
Effects of Early Sleep After Action Observation Therapy on Balance in Elderly
A study testing Action Observation Therapy in people with Old Age; Debility and Balance; Distorted, run by Istituto Clinico Humanitas.
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. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Old Age; Debility, Balance; Distorted
- What is being tested?
- Action Observation Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2022to 15 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Ability to walk for at least 100 meters with no assistance or aids
Who cannot join
- 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
About this study
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
- Being tested
- Action Observation Therapy
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action Observation TherapyBehavioural
Action Observation Therapy implies the observation of video-clips representing motor tasks alone or followed by imagination and/or imitation of observed tasks.
| Study group | Role | What they receive |
|---|---|---|
| AOT-sleep | Experimental | They will be asked to watch video-clips representing motor contents before sleeping. Receives: 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. Receives: Behavioral: Action Observation Therapy |
| Control | Sham comparator | They will be asked to watch video-clips representing landscapes before sleeping. Receives: Behavioral: Action Observation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Lower Quarter Y-Balance Test
The outcome measure is aimed at investigating changes in terms of static balance
Measured: 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
Measured: 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
Measured: 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
Measured: At baseline, 3 weeks of training and 1 month after the training end
Secondary outcomes (6)
Changes in center of pressure parameters
The outcome measure is aimed at investigating changes in terms of postural stability
Measured: 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
Measured: 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)
Measured: 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).
Measured: 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."
Measured: 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).
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start15 Jun 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion15 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Old Age; DebilityStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Tedeschi, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393700
- Sponsor's protocol ID
- CLF22/01
- Status last verified
- May 2022
- First submitted
- 20 May 2022
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Early Sleep After Action Observation Therapy on Balance in Elderly
- ClinicalTrials.gov ID
- NCT05393700
- Acronym / sponsor ID
- CLF22/01
- Conditions
- Old Age; Debility, Balance; Distorted
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 15 Jun 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 15 Jun 2023 (estimated)
- First posted
- 26 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AOT-sleep | Experimental | Behavioral: Action Observation TherapyThey will be asked to watch video-clips representing motor contents before sleeping. |
| AOT-control | Active comparator | Behavioral: Action Observation TherapyThey will be asked to watch video-clips representing motor contents at least 12 hours before sleeping. |
| Control | Sham comparator | Behavioral: Action Observation TherapyThey will be asked to watch video-clips representing landscapes before sleeping. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Ability to walk for at least 100 meters with no assistance or aids
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Action Observation TherapyAction Observation Therapy implies the observation of video-clips representing motor tasks alone or followed by imagination and/or imitation of observed tasks. | Behavioural | AOT-control, AOT-sleep, Control |
Primary outcome
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
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
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
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
6 secondary outcomes
Changes in center of pressure parameters
Time frame: 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
Pittsburg Quality Sleep Index
Time frame: 3 weeks
Kinesthetic and Visual Imagery Questionnaire
Time frame: At baseline
Morningness Eveningness Scale
Time frame: At baseline
Euro Quality of Life - 5 dimensions
Time frame: At baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Action Observation Therapy in people with Old Age; Debility and Balance; Distorted, run by Istituto Clinico Humanitas.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Lower Quarter Y-Balance Test (time frame: At baseline, 3 weeks and 1 month after the training end). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022.