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

NCT06306885 | Not Yet Recruiting

• 1 other identifier: CLF23/03
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hand Injuries; Action Observation; Motor Imagery

Outcome Measures

Primary Outcomes (1)

• Changes in Purdue Pegboard Test

  Manual dexterity test

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

Secondary Outcomes (6)

• Changes in kinematic indexes during Nine Hole Peg Test

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

• Changes in Visual Analogue Scale

  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 EQ5D

  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

Study Arms (3)

AOMI-sleep

EXPERIMENTAL

Observation and imagination of video-clips with motor contents before sleeping

Behavioral: Action observation plus motor imagery followed by sleep

AOMI-control

ACTIVE COMPARATOR

Observation and imagination of video-clips with motor contents in the morning

Behavioral: Action observation plus motor imagery

Control

SHAM COMPARATOR

Observation and imagination of landscapes video-clips

Behavioral: Control

Interventions

Action observation plus motor imagery followed by sleep BEHAVIORAL

Participants will be asked to observe video-clips showing motor contents immediately before sleeping

AOMI-sleep

Action observation plus motor imagery BEHAVIORAL

Participants will be asked to observe video-clips showing motor contents at least 12 hours before sleeping

AOMI-control

Control BEHAVIORAL

Participants will be asked to observe video-clips showing landscapes before sleeping

Control

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

MeSH Terms

Conditions

Hand Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 12, 2024
• Study Start: March 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: May 1, 2025
• Last Updated: March 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share