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Clinical Trials/NCT06306885
NCT06306885
Not yet recruiting
Not Applicable

Effects of Early Sleep After Action Observation and Motor Imagery in Patients Undergoing Immobilization After Surgery for Metacarpal and Phalangeal Fractures

Istituto Clinico Humanitas0 sites51 target enrollmentMarch 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hand Injuries
Sponsor
Istituto Clinico Humanitas
Enrollment
51
Primary Endpoint
Changes in Purdue Pegboard Test
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
March 1, 2024
End Date
May 1, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Istituto Clinico Humanitas
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Changes in Purdue Pegboard Test

Time Frame: Before and after 2 weeks of training and at 1 month follow-up

Manual dexterity test

Secondary Outcomes

  • Changes in Visual Analogue Scale(Before and after 2 weeks of training and at 1 month follow-up)
  • Hand-grip strength(1-month follow-up)
  • Changes in EQ5D(Before and after 2 weeks of training and at 1 month follow-up)
  • Changes in kinematic indexes during Nine Hole Peg Test(Before and after 2 weeks of training and at 1 month follow-up)
  • Changes in Quick-DASH(Before and after 2 weeks of training and at 1 month follow-up)
  • Changes in Total Active Motion(Before and after 2 weeks of training and at 1 month follow-up)

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