Effects of Early Sleep After Action Observation and Motor Imagery After Metacarpal Fracture Surgery
NCT ID: NCT06306885
Last Updated: 2024-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
51 participants
INTERVENTIONAL
2024-03-01
2025-05-01
Brief Summary
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Fifty-one patients with hand immobilization for surgical fixation of IV or V metacarpals or first phalanges fractures will be randomized into AOMI-sleep (n=17), AOMI-control (n=17), and Control (n=17) group. AOMI-sleep and AOMI-control groups will perform an AOMI-training before sleeping or in the morning respectively, while Control group will be asked to observe landscape video-clips. Participants will be assessed for manual dexterity, hand range of motion, hand disability and quality of life at baseline before and after the training and at 1 month after the training end.
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Detailed Description
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Fifty-one patients with right hand immobilization for surgical fixation of IV or V metacarpals or first phalanges fractures will be randomized into an AOMI-sleep (n=17), AOMI-control (n=17), and Control (n=17) group. AOMI-sleep and AOMI-control groups will perform a 2-week AOMI-training including transitive manual dexterity tasks between 8:00 and 10:00 p.m. or between 8:00 and 10:00 a.m. respectively, while Control group participants will be asked to observe landscape video-clips between 8:00 and 10:00 p.m. Participants will be assessed for manual dexterity (Purdue Pegboard Test and kinematic indexes during Nine Hole Peg Test), hand range of motion (Total Active Motion) hand disability (Quick-DASH) and quality of life (EQ5D) at baseline (1 week after surgery), training end (3 weeks after surgery) and 1 month after the training end (7 weeks after surgery).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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AOMI-sleep
Observation and imagination of video-clips with motor contents before sleeping
Action observation plus motor imagery followed by sleep
Participants will be asked to observe video-clips showing motor contents immediately before sleeping
AOMI-control
Observation and imagination of video-clips with motor contents in the morning
Action observation plus motor imagery
Participants will be asked to observe video-clips showing motor contents at least 12 hours before sleeping
Control
Observation and imagination of landscapes video-clips
Control
Participants will be asked to observe video-clips showing landscapes before sleeping
Interventions
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Action observation plus motor imagery followed by sleep
Participants will be asked to observe video-clips showing motor contents immediately before sleeping
Action observation plus motor imagery
Participants will be asked to observe video-clips showing motor contents at least 12 hours before sleeping
Control
Participants will be asked to observe video-clips showing landscapes before sleeping
Eligibility Criteria
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Inclusion Criteria
* Age 18-40 years old
* Right-hand dominance
Exclusion Criteria
* Occurrence of left upper limb injuries
* Post-surgical complications (e.g. CPRS)
* Immobilization \<12 or \>30 days
* Diagnosis of neurological/musculoskeletal conditions
* Sports or activities requiring advanced manual skills or sleep deprivation
* History of psychiatric disorders
* Sleep disorders (e.g. insomnia, OSAS, REN or Non-REM behavioural disorders)
* Medication affecting the physiological sleep pattern
18 Years
40 Years
ALL
No
Sponsors
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Istituto Clinico Humanitas
OTHER
Responsible Party
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Other Identifiers
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CLF23/03
Identifier Type: -
Identifier Source: org_study_id
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