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

March 5, 2024 updated by: Istituto Clinico Humanitas

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

51

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AOMI-sleep
Observation and imagination of video-clips with motor contents before sleeping
Behavioral: Action observation plus motor imagery followed by sleep
Participants will be asked to observe video-clips showing motor contents immediately before sleeping
Active Comparator: AOMI-control
Observation and imagination of video-clips with motor contents in the morning
Behavioral: Action observation plus motor imagery
Participants will be asked to observe video-clips showing motor contents at least 12 hours before sleeping
Sham Comparator: Control
Observation and imagination of landscapes video-clips
Behavioral: Control
Participants will be asked to observe video-clips showing landscapes before sleeping

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Purdue Pegboard Test
Time Frame: Before and after 2 weeks of training and at 1 month follow-up
Manual dexterity test
Before and after 2 weeks of training and at 1 month follow-up

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Clinico Humanitas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

February 27, 2024

First Submitted That Met QC Criteria

March 5, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLF23/03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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