Hand InjuriesNCT06306885
Effects of Early Sleep After Action Observation and Motor Imagery After Metacarpal Fracture Surgery
A study testing Action observation plus motor imagery followed by sleep and Action observation plus motor imagery in people with Hand Injuries and Action Observation, run by Istituto Clinico Humanitas.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Hand Injuries, Action Observation, Motor Imagery
- What is being tested?
- Action observation plus motor imagery followed by sleep and Action observation plus motor imagery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- History of psychiatric disorders
- Sleep disorders (e.g. insomnia, OSAS, REN or Non-REM behavioural disorders)
- Medication affecting the physiological sleep pattern
About this study
Official title: 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.
Read the 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).
- Conditions
- Hand Injuries, Action Observation, Motor Imagery
- Being tested
- Action observation plus motor imagery followed by sleep, Action observation plus motor imagery, Control
- Medical subject headings
- Hand Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action observation plus motor imagery followed by sleepBehavioural
Participants will be asked to observe video-clips showing motor contents immediately before sleeping
Action observation plus motor imageryBehavioural
Participants will be asked to observe video-clips showing motor contents at least 12 hours before sleeping
ControlBehavioural
Participants will be asked to observe video-clips showing landscapes before sleeping
| Study group | Role | What they receive |
|---|---|---|
| AOMI-sleep | Experimental | Observation and imagination of video-clips with motor contents before sleeping Receives: 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 Receives: Behavioral: Action observation plus motor imagery |
| Control | Sham comparator | Observation and imagination of landscapes video-clips Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Purdue Pegboard Test
Manual dexterity test
Measured: 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
Manual dexterity test with kinematic indexes recording
Measured: Before and after 2 weeks of training and at 1 month follow-up
Changes in Visual Analogue Scale
Scale assessing perceived pain
Measured: Before and after 2 weeks of training and at 1 month follow-up
Changes in Quick-DASH
Questionnaire assessing upper limb disability
Measured: Before and after 2 weeks of training and at 1 month follow-up
Changes in EQ5D
Questionnaire assessing quality of life
Measured: Before and after 2 weeks of training and at 1 month follow-up
Changes in Total Active Motion
Measurement of the range of motion of V and IV fingers
Measured: Before and after 2 weeks of training and at 1 month follow-up
Hand-grip strength
Test of maximal strength with a dynamometer
Measured: 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand InjuriesStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06306885
- Sponsor's protocol ID
- CLF23/03
- Status last verified
- Feb 2024
- First submitted
- 27 Feb 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Early Sleep After Action Observation and Motor Imagery in Patients Undergoing Immobilization After Surgery for Metacarpal and Phalangeal Fractures
- ClinicalTrials.gov ID
- NCT06306885
- Acronym / sponsor ID
- CLF23/03
- Conditions
- Hand Injuries, Action Observation, Motor Imagery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AOMI-sleep | Experimental | Behavioral: Action observation plus motor imagery followed by sleepObservation and imagination of video-clips with motor contents before sleeping |
| AOMI-control | Active comparator | Behavioral: Action observation plus motor imageryObservation and imagination of video-clips with motor contents in the morning |
| Control | Sham comparator | Behavioral: ControlObservation and imagination of landscapes video-clips |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Action observation plus motor imagery followed by sleepParticipants will be asked to observe video-clips showing motor contents immediately before sleeping | Behavioural | AOMI-sleep |
| Action observation plus motor imageryParticipants will be asked to observe video-clips showing motor contents at least 12 hours before sleeping | Behavioural | AOMI-control |
| ControlParticipants will be asked to observe video-clips showing landscapes before sleeping | Behavioural | Control |
Primary outcome
Changes in Purdue Pegboard Test
Time frame: Before and after 2 weeks of training and at 1 month follow-up
Manual dexterity test
6 secondary outcomes
Changes in kinematic indexes during Nine Hole Peg Test
Time frame: 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
Changes in Quick-DASH
Time frame: 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
Changes in Total Active Motion
Time frame: Before and after 2 weeks of training and at 1 month follow-up
Hand-grip strength
Time frame: 1-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Action observation plus motor imagery followed by sleep and Action observation plus motor imagery in people with Hand Injuries and Action Observation, run by Istituto Clinico Humanitas.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Purdue Pegboard Test (time frame: Before and after 2 weeks of training and at 1 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.