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

Hand Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06306885
• Other study ID #: CLF23/03
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: May 1, 2025

Study information

• Verified date: February 2024
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 51
• Est. completion date: May 1, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Hand Injuries
• Motor Imagery

Intervention

Behavioral:
• Action observation plus motor imagery followed by sleep
Participants will be asked to observe video-clips showing motor contents immediately before sleeping
• Action observation plus motor imagery
Participants will be asked to observe video-clips showing motor contents at least 12 hours before sleeping
• Control
Participants will be asked to observe video-clips showing landscapes before sleeping

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Outcome

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