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

I

Istituto Clinico Humanitas

Status

Not yet enrolling

Conditions

Action Observation
Hand Injuries
Motor Imagery

Treatments

Behavioral: Action observation plus motor imagery
Behavioral: Control
Behavioral: Action observation plus motor imagery followed by sleep

Study type

Interventional

Funder types

Other

Identifiers

NCT06306885
CLF23/03

Details and patient eligibility

About

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.

Full 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).

Enrollment

51 estimated patients

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

51 participants in 3 patient groups

AOMI-sleep
Experimental group
Description:
Observation and imagination of video-clips with motor contents before sleeping
Treatment:
Behavioral: Action observation plus motor imagery followed by sleep
AOMI-control
Active Comparator group
Description:
Observation and imagination of video-clips with motor contents in the morning
Treatment:
Behavioral: Action observation plus motor imagery
Control
Sham Comparator group
Description:
Observation and imagination of landscapes video-clips
Treatment:
Behavioral: Control

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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