Clinical trial NCT06306885: Effects of Early Sleep After Action Observation and Motor Imagery After Metacarpal Fracture Surgery
Official title: Effects of Early Sleep After Action Observation and Motor Imagery in Patients Undergoing Immobilization After Surgery for Metacarpal and Phalangeal Fractures
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hand Injuries
Action Observation
Motor Imagery
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aimed to investigate the effects of early sleep after action observation and motor imagery (AOMI) training sessions on manual dexterity in patients with hand immobilization after surgical fixation for metacarpals and phalanges fractures.

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.

Detailed description: The study aimed to investigate the effects of early sleep after action observation and motor imagery (AOMI) training sessions on manual dexterity in patients with hand immobilization after surgical fixation for metacarpals and phalanges fractures.

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).

Eligibility criteria: Inclusion Criteria:

* Surgical fixation for IV or V MTC or P1 fracture at the level of the right hand
* Age 18-40 years old
* Right-hand dominance

Exclusion Criteria:

* Damage to additional hand structure requiring surgery (e.g. tendons, ligaments and nerves)
* 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

Primary outcomes:
measure: Changes in Purdue Pegboard Test
timeFrame: Before and after 2 weeks of training and at 1 month follow-up
Secondary outcomes:
measure: Changes in kinematic indexes during Nine Hole Peg Test
timeFrame: Before and after 2 weeks of training and at 1 month follow-up
measure: Changes in Visual Analogue Scale
timeFrame: Before and after 2 weeks of training and at 1 month follow-up
measure: Changes in Quick-DASH
timeFrame: Before and after 2 weeks of training and at 1 month follow-up
measure: Changes in EQ5D
timeFrame: Before and after 2 weeks of training and at 1 month follow-up
measure: Changes in Total Active Motion
timeFrame: Before and after 2 weeks of training and at 1 month follow-up
measure: Hand-grip strength
timeFrame: 1-month follow-up
Other outcomes:
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