Effects of Early Sleep After Action Observation and Motor Imagery After Metacarpal Fracture Surgery

Not Applicable

Not yet recruiting

• Conditions: Action Observation; Hand Injuries; Motor Imagery
• Interventions: Behavioral: Action observation plus motor imagery followed by sleep; Behavioral: Action observation plus motor imagery; Behavioral: Control

• Registration Number: NCT06306885
• Lead Sponsor: Istituto Clinico Humanitas

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).

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-27
• Study Start: 2024-03-01
• Study First Submitted QC: 2024-03-05
• Last Update Submitted: 2024-03-05
• Study First Posted: 2024-03-12
• Last Update Posted: 2024-03-12
• Primary Completion: 2024-09-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AOMI-sleep	Action observation plus motor imagery followed by sleep	Observation and imagination of video-clips with motor contents before sleeping
AOMI-control	Action observation plus motor imagery	Observation and imagination of video-clips with motor contents in the morning
Control	Control	Observation and imagination of landscapes video-clips

Primary Outcome Measures

Name	Time	Method
Changes in Purdue Pegboard Test	Before and after 2 weeks of training and at 1 month follow-up	Manual dexterity test

Secondary Outcome Measures

Name	Time	Method
Changes in Visual Analogue Scale	Before and after 2 weeks of training and at 1 month follow-up	Scale assessing perceived pain
Hand-grip strength	1-month follow-up	Test of maximal strength with a dynamometer
Changes in EQ5D	Before and after 2 weeks of training and at 1 month follow-up	Questionnaire assessing quality of life
Changes in kinematic indexes during Nine Hole Peg Test	Before and after 2 weeks of training and at 1 month follow-up	Manual dexterity test with kinematic indexes recording
Changes in Quick-DASH	Before and after 2 weeks of training and at 1 month follow-up	Questionnaire assessing upper limb disability
Changes in Total Active Motion	Before and after 2 weeks of training and at 1 month follow-up	Measurement of the range of motion of V and IV fingers