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

NCT ID: NCT06306885

Last Updated: 2024-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2025-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hand Injuries Action Observation Motor Imagery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AOMI-sleep

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

Group Type EXPERIMENTAL

Action observation plus motor imagery followed by sleep

Intervention Type BEHAVIORAL

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

AOMI-control

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

Group Type ACTIVE_COMPARATOR

Action observation plus motor imagery

Intervention Type BEHAVIORAL

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

Control

Observation and imagination of landscapes video-clips

Group Type SHAM_COMPARATOR

Control

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Action observation plus motor imagery followed by sleep

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

Intervention Type BEHAVIORAL

Action observation plus motor imagery

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

Intervention Type BEHAVIORAL

Control

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istituto Clinico Humanitas

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CLF23/03

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.