Wrist InjuriesNCT04739644

Robot-based Wrist Rehabilitation in Orthopaedics: Efficacy and Comparison With Traditional Methods

A study testing Specific wrist rehabilitation by WRISTBOT device, Specific wrist rehabilitation performed by the physiotherapist and General rehabilitation in people with Wrist Injuries, run by Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The present randomized clinical trial addresses the issue about the application of robot-based rehabilitation programs in orthopedic conditions. The aim of the study is to test the efficacy of a robot-based rehabilitative protocol to recover wrist functionality after traumatic injuries. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Wrist Injuries
What is being tested?: Specific wrist rehabilitation by WRISTBOT device, Specific wrist rehabilitation performed by the physiotherapist and General rehabilitation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: No sites listed yet
Study dates: 7 Jan 2015to 14 Jun 2018
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Functional and spatial limitations of the wrist joint, following an injury occurred at workplace
Post-immobilization phase
Temporal distance from the acute event not exceeding 6 months
Signed informed consent acquisition

Who cannot join

Non-compliance with study requirements
Pregnancy or breast feeding; Current or prior history of malignancy
Open skin at the level of the patient-device interface
Sensory deficit at the level of the patient-device interface
Acute inflammatory arthritis of the wrist
Contraindications to passive movements

About this study

Official title: Robot-based Wrist Rehabilitation After Orthopaedic Trauma: a Pilot Randomised Controlled Trial

Read the detailed description

Thirty patients with work related wrist injuries resulting in wrist joint dysfunction are enrolled in an open randomized controlled trial over a 24 months period. Each participant is randomly allocated to experimental or control group and receives a 3-week rehabilitation program including both assessment and rehabilitative sessions. While patients in the control group undergo a traditional rehabilitative protocol, the experimental group is treated replacing traditional exercises with robot-aided ones performed with WRISTBOT, a 3 Degrees of Freedom (DoFs) robotic exoskeleton. WRISTBOT allows for passive, active and assisted range-of-motion (ROM) exercises, isotonic and elastic tasks, proprioceptive and perturbation training. All subjects perform the same sessions of assessment, which include two evaluations through the robotic system and clinical measures at the beginning (Tb) and at the end (Te) of the rehabilitative training, and a follow-up through phone call, three months after the end of the treatment (Tf). The assessment sessions include a robot-based evaluation (measurement of ROM, exerted forces, dexterity, and wrist position sense acuity) and clinical measures (Patient Rated Wrist Evaluation, Jebsen-Taylor and Jamar Test). Subjects' level of satisfaction about treatment is asked at the end of the rehabilitative treatment (Te). The primary objective is to evaluate the results of a robot-based rehabilitative approach on wrist functionality after work-related trauma, comparing the effects of robotic therapy with those achieved through a conventional therapy.

Conditions: Wrist Injuries
Being tested: Specific wrist rehabilitation by WRISTBOT device, Specific wrist rehabilitation performed by the physiotherapist, General rehabilitation
Keywords: Adult, Humans, Middle aged, Robotics / instrumentation*, Wrist Injuries / physiopathology, Wrist Injuries / rehabilitation*
Medical subject headings: Wrist Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Specific wrist rehabilitation by WRISTBOT deviceDevice
The WRISTBOT is a fully backdrivable manipulandum that allows for movements along its 3 Degrees of Freedom (DoFs) in a human-like Range Of Motion (ROM) of the wrist: 62° flexion/extension (FE), -40°/+45° in ulnar/radial deviation (RUD), and 60° pronation/supination (PS). In addition, the robot permits motions along planes that involve combined multi-DoFs movements. Mechanically, the robot was developed to have low values of inertia, emulating the fluency of natural movements. Each DOF is measured by high resolution incremental encoders and actuated by one brushless motor or two in case of the RUD planes, providing both gravity compensation and continuous torque values necessary to manipulate the human wrist joints. Depending on the torques exerted, the device can be used in either active or assistive/passive modality. The system is integrated with a Virtual Reality environment (VR), useful to provide a visual feedback to the user while he/she is requested to complete the tasks.
Specific wrist rehabilitation performed by the physiotherapistOther
Passive, active and assisted mobilization
General rehabilitationOther
Exercise with elastic bands or weights, exercise of manipulation and dexterity, simulation of daily life activities supervised by the physiotherapist

Study groups in NCT04739644
Study group	Role	What they receive
Experimental: WRISTBOT Group	Experimental	The patients in the "WRISTBOT Group" underwent to following interventions: 1. General Rehabilitation 2. Specific wrist rehabilitation by WRISTBOT device Receives: Device: Specific wrist rehabilitation by WRISTBOT device; Other: General rehabilitation
Control group	Active comparator	The patients in the Control Group underwent to following interventions: 1. General Rehabilitation 2. Specific wrist rehabilitation performed by physiotherapist. Receives: Other: Specific wrist rehabilitation performed by the physiotherapist; Other: General rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline Jamar Test at 3th week
Using a hand dynamometer, subjects perform three trials to evaluate the mean static palmar force exerted in kg
Measured: Up to 3 weeks
Change from baseline Jebsen Taylor Hand Function Test (JTHFT) at 3th week
Consist of six items, its aim is to evaluate dexterity in terms of fine motor skills, weighted functional tasks and non-weighted functional tasks. Each item is scored according to the time taken to complete the task
Measured: Up to 3 weeks
Change from baseline Patient Rated Wrist/Hand Evaluation (PRWE) at 3th week
A questionnaire composed of a pain (PRWE-P) and a function (PRWE-F) subscale. Each subsection has a maximum score of 50 and a minimum of 0, where less score points out a better performance
Measured: Up to 3 weeks
Change from 3th week (Te) Patient Rated Wrist/Hand Evaluation (PRWE) at the follow-up assessment after 3 months (Tf)
A questionnaire composed of a pain (PRWE-P) and a function (PRWE-F) subscale. Each subsection has a maximum score of 50 and a minimum of 0, where less score points out a better performance
Measured: Up to 3 months from Te
Change from baseline Passive ROM (robotic assessment) at 3th week
Starting from the neutral position (0° along each DoF), the device moves the wrist of the subject along different directions until subject's maximum tolerance, notified by himself/herself pushing a button with the not injured hand. Target directions are 8 equally distributed in the Flexion-Extension/Radial-Ulnar Deviation (FE/RUD) space, and 2 along Pronation-Supination. Outcome measures consist in the maximum ROM in degrees achieved along each direction.
Measured: Up to 3 weeks
Change from baseline Active ROM (robotic assessment) at 3th week
From the initial neutral position, subjects move actively the device as far as they could, along the same directions of the Passive ROM assessment. Any assistive force is applied, but the weight of the device is compensated during active motions. The outcome measure is the maximum active ROM in degrees achieved along each direction.
Measured: Up to 3 weeks
Change from baseline Isometric Force (robotic assessment) at 3th week
While the device keeps subjects on the wrist neutral position, they are requested to perform a maximal contraction toward different directions. While subjects push towards each target direction, the device resisted to the imposed force, such that no motion is performed. The outcome measure is maximal peak force in Newton measured along each direction (same directions as in ROM assessment).
Measured: Up to 3 weeks
Change from baseline Target Tracking (robotic assessment) at 3th week
Subjects have to follow a target moving on a first order Lissajous trajectory, showed on the screen two-dimensional space. Subjects perform two laps, actively moving in two different directions of rotation (counter and clockwise) across the space described by combinations of FE/RUD motions. The size of the figure is determined by the 75% of the smallest assessed ROM in each direction. The resulting outcome measure is the mean figural error in degrees, i.e. the average angular distance between target and end-effector trajectory in each sampled point.
Measured: Up to 3 weeks
Change from baseline Joint Position Matching (robotic assessment) at 3th week
While the subject is blindfolded, the device moves his/her wrist in a defined direction, until the 75% of the subject's ROM along that direction. After 3 seconds, the wrist is passively brought back to the neutral position. Then, maintaining the blindfolded condition, the subject is asked to reproduce the joint configuration previously assumed passively. Target directions corresponded to the same directions along which the ROM has been assessed. Performance is measured in terms of matching error, i.e. the Euclidean distance between target and matched points. Matching error is measured in degrees.
Measured: Up to 3 weeks

Secondary outcomes (2)

Number of Recorded Side effects
Side effects using WRISTBOT device
Measured: Through study completion, up to 3 weeks
Patient Satisfaction
Subjects were asked to indicate their approval rating of the rehabilitation program through a Numerical Rating Scale (NRS) from 0 (least satisfied) to 10 (most satisfied)
Measured: After 3 weeks intervention (Te)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jan 201514 Jun 2018

First posted4 Feb 2021
Study start7 Jan 2015
Primary completion14 Jun 2018
Study completion14 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Wrist InjuriesStudies of the same condition, open and under way.
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
Model description: The study considers participants divided in two groups: the control group and the experimental group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04739644
Sponsor's protocol ID: CRMINAIL03
Status last verified: Jan 2021
First submitted: 27 Jan 2021
Last updated: 4 Feb 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Karagiannopoulos C, Sitler M, Michlovitz S, Tierney R. A descriptive study on wrist and hand sensori-motor impairment and function following distal radius fracture intervention. J Hand Ther. 2013 Jul-Sep;26(3):204-14; quiz 215. doi: 10.1016/j.jht.2013.03.004. Epub 2013 Apr 28.
PubMed 23628557
Bruder AM, Taylor NF, Dodd KJ, Shields N. Physiotherapy intervention practice patterns used in rehabilitation after distal radial fracture. Physiotherapy. 2013 Sep;99(3):233-40. doi: 10.1016/j.physio.2012.09.003. Epub 2012 Nov 30.
PubMed 23200599
Bruder A, Taylor NF, Dodd KJ, Shields N. Exercise reduces impairment and improves activity in people after some upper limb fractures: a systematic review. J Physiother. 2011;57(2):71-82. doi: 10.1016/S1836-9553(11)70017-0.
PubMed 21684488
Krischak GD, Krasteva A, Schneider F, Gulkin D, Gebhard F, Kramer M. Physiotherapy after volar plating of wrist fractures is effective using a home exercise program. Arch Phys Med Rehabil. 2009 Apr;90(4):537-44. doi: 10.1016/j.apmr.2008.09.575.
PubMed 19345766
Handoll HH, Madhok R, Howe TE. Rehabilitation for distal radial fractures in adults. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD003324. doi: 10.1002/14651858.CD003324.pub2.
PubMed 16856004
Glasgow C, Tooth LR, Fleming J. Mobilizing the stiff hand: combining theory and evidence to improve clinical outcomes. J Hand Ther. 2010 Oct-Dec;23(4):392-400; quiz 401. doi: 10.1016/j.jht.2010.05.005. Epub 2010 Sep 9.
PubMed 20828988
Schwartz DA. Static progressive orthoses for the upper extremity: a comprehensive literature review. Hand (N Y). 2012 Mar;7(1):10-7. doi: 10.1007/s11552-011-9380-2. Epub 2011 Dec 16.
PubMed 23450213
Masia L, Casadio M, Sandini G, Morasso P. Eye-hand coordination during dynamic visuomotor rotations. PLoS One. 2009 Sep 15;4(9):e7004. doi: 10.1371/journal.pone.0007004.
PubMed 19753120
Casadio M, Sanguineti V, Squeri V, Masia L, Morasso P. Inter-limb interference during bimanual adaptation to dynamic environments. Exp Brain Res. 2010 May;202(3):693-707. doi: 10.1007/s00221-010-2175-9. Epub 2010 Feb 20.
PubMed 20174919
Masia L, Squeri V, Saha D, Burdet E, Sandini G, Morasso P. Stabilizing unstable object by means of kinematic redundancy. Annu Int Conf IEEE Eng Med Biol Soc. 2010;2010:3698-702. doi: 10.1109/IEMBS.2010.5627438.
PubMed 21096858
Squeri V, Masia L, Casadio M, Morasso P, Vergaro E. Force-field compensation in a manual tracking task. PLoS One. 2010 Jun 17;5(6):e11189. doi: 10.1371/journal.pone.0011189.
PubMed 20567516
Jebsen RH, Taylor N, Trieschmann RB, Trotter MJ, Howard LA. An objective and standardized test of hand function. Arch Phys Med Rehabil. 1969 Jun;50(6):311-9. No abstract available.
PubMed 5788487
Fairplay T, Atzei A, Corradi M, Luchetti R, Cozzolino R, Schoenhuber R. Cross-cultural adaptation and validation of the Italian version of the patient-rated wrist/hand evaluation questionnaire. J Hand Surg Eur Vol. 2012 Nov;37(9):863-70. doi: 10.1177/1753193412445160. Epub 2012 Jun 19.
PubMed 22719008
Albanese GA, Taglione E, Gasparini C, Grandi S, Pettinelli F, Sardelli C, Catitti P, Sandini G, Masia L, Zenzeri J. Efficacy of wrist robot-aided orthopedic rehabilitation: a randomized controlled trial. J Neuroeng Rehabil. 2021 Aug 31;18(1):130. doi: 10.1186/s12984-021-00925-0.
PubMed 34465356

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Wrist Injuries trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Robot-based Wrist Rehabilitation After Orthopaedic Trauma: a Pilot Randomised Controlled Trial
ClinicalTrials.gov ID: NCT04739644
Acronym / sponsor ID: CRMINAIL03
Conditions: Wrist Injuries
Keywords: Adult, Humans, Middle aged, Robotics / instrumentation*, Wrist Injuries / physiopathology, Wrist Injuries / rehabilitation*
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Istituto Nazionale Assicurazione contro gli Infortuni sul LavoroUniversity, hospital or other
Collaborators: Istituto Italiano di Tecnologia
Study start: 7 Jan 2015 (actual)
Primary completion: 14 Jun 2018 (actual)
Study completion: 14 Jun 2018 (actual)
First posted: 4 Feb 2021 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: The study considers participants divided in two groups: the control group and the experimental group

Arm	Type	Receives
Experimental: WRISTBOT Group	Experimental	Device: Specific wrist rehabilitation by WRISTBOT device, Other: General rehabilitationThe patients in the "WRISTBOT Group" underwent to following interventions: 1. General Rehabilitation 2. Specific wrist rehabilitation by WRISTBOT device
Control group	Active comparator	Other: Specific wrist rehabilitation performed by the physiotherapist, Other: General rehabilitationThe patients in the Control Group underwent to following interventions: 1. General Rehabilitation 2. Specific wrist rehabilitation performed by physiotherapist.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Functional and spatial limitations of the wrist joint, following an injury occurred at workplace
Post-immobilization phase
Temporal distance from the acute event not exceeding 6 months
Signed informed consent acquisition

Key exclusion criteria (6 listed)

Non-compliance with study requirements
Pregnancy or breast feeding; Current or prior history of malignancy
Open skin at the level of the patient-device interface
Sensory deficit at the level of the patient-device interface
Acute inflammatory arthritis of the wrist

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
Specific wrist rehabilitation by WRISTBOT deviceThe WRISTBOT is a fully backdrivable manipulandum that allows for movements along its 3 Degrees of Freedom (DoFs) in a human-like Range Of Motion (ROM) of the wrist: 62° flexion/extension (FE), -40°/+45° in ulnar/radial deviation (RUD), and 60° pronation/supination (PS). In addition, the robot permits motions along planes that involve combined multi-DoFs movements. Mechanically, the robot was developed to have low values of inertia, emulating the fluency of natural movements. Each DOF is measured by high resolution incremental encoders and actuated by one brushless motor or two in case of the RUD planes, providing both gravity compensation and continuous torque values necessary to manipulate the human wrist joints. Depending on the torques exerted, the device can be used in either active or assistive/passive modality. The system is integrated with a Virtual Reality environment (VR), useful to provide a visual feedback to the user while he/she is requested to complete the tasks.	Device	Experimental: WRISTBOT Group
Specific wrist rehabilitation performed by the physiotherapistPassive, active and assisted mobilization	Other	Control group
General rehabilitationExercise with elastic bands or weights, exercise of manipulation and dexterity, simulation of daily life activities supervised by the physiotherapist	Other	Control group, Experimental: WRISTBOT Group

Primary outcome

Change from baseline Jamar Test at 3th week
Time frame: Up to 3 weeks
Using a hand dynamometer, subjects perform three trials to evaluate the mean static palmar force exerted in kg
Change from baseline Jebsen Taylor Hand Function Test (JTHFT) at 3th week
Time frame: Up to 3 weeks
Consist of six items, its aim is to evaluate dexterity in terms of fine motor skills, weighted functional tasks and non-weighted functional tasks. Each item is scored according to the time taken to complete the task
Change from baseline Patient Rated Wrist/Hand Evaluation (PRWE) at 3th week
Time frame: Up to 3 weeks
A questionnaire composed of a pain (PRWE-P) and a function (PRWE-F) subscale. Each subsection has a maximum score of 50 and a minimum of 0, where less score points out a better performance
Change from 3th week (Te) Patient Rated Wrist/Hand Evaluation (PRWE) at the follow-up assessment after 3 months (Tf)
Time frame: Up to 3 months from Te
A questionnaire composed of a pain (PRWE-P) and a function (PRWE-F) subscale. Each subsection has a maximum score of 50 and a minimum of 0, where less score points out a better performance
Change from baseline Passive ROM (robotic assessment) at 3th week
Time frame: Up to 3 weeks
Starting from the neutral position (0° along each DoF), the device moves the wrist of the subject along different directions until subject's maximum tolerance, notified by himself/herself pushing a button with the not injured hand. Target directions are 8 equally distributed in the Flexion-Extension/Radial-Ulnar Deviation (FE/RUD) space, and 2 along Pronation-Supination. Outcome measures consist in the maximum ROM in degrees achieved along each direction.
Change from baseline Active ROM (robotic assessment) at 3th week
Time frame: Up to 3 weeks
From the initial neutral position, subjects move actively the device as far as they could, along the same directions of the Passive ROM assessment. Any assistive force is applied, but the weight of the device is compensated during active motions. The outcome measure is the maximum active ROM in degrees achieved along each direction.
Change from baseline Isometric Force (robotic assessment) at 3th week
Time frame: Up to 3 weeks
While the device keeps subjects on the wrist neutral position, they are requested to perform a maximal contraction toward different directions. While subjects push towards each target direction, the device resisted to the imposed force, such that no motion is performed. The outcome measure is maximal peak force in Newton measured along each direction (same directions as in ROM assessment).
Change from baseline Target Tracking (robotic assessment) at 3th week
Time frame: Up to 3 weeks
Subjects have to follow a target moving on a first order Lissajous trajectory, showed on the screen two-dimensional space. Subjects perform two laps, actively moving in two different directions of rotation (counter and clockwise) across the space described by combinations of FE/RUD motions. The size of the figure is determined by the 75% of the smallest assessed ROM in each direction. The resulting outcome measure is the mean figural error in degrees, i.e. the average angular distance between target and end-effector trajectory in each sampled point.
Change from baseline Joint Position Matching (robotic assessment) at 3th week
Time frame: Up to 3 weeks
While the subject is blindfolded, the device moves his/her wrist in a defined direction, until the 75% of the subject's ROM along that direction. After 3 seconds, the wrist is passively brought back to the neutral position. Then, maintaining the blindfolded condition, the subject is asked to reproduce the joint configuration previously assumed passively. Target directions corresponded to the same directions along which the ROM has been assessed. Performance is measured in terms of matching error, i.e. the Euclidean distance between target and matched points. Matching error is measured in degrees.

2 secondary outcomes

Number of Recorded Side effects
Time frame: Through study completion, up to 3 weeks
Patient Satisfaction
Time frame: After 3 weeks intervention (Te)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
Background: PubMed 23628557Karagiannopoulos C, Sitler M, Michlovitz S, Tierney R. A descriptive study on wrist and hand sensori-motor impairment and function following distal radius fracture intervention. J Hand Ther. 2013 Jul-Sep;26(3):204-14; quiz 215. doi: 10.1016/j.jht.2013.03.004. Epub 2013 Apr 28.
Background: PubMed 23200599Bruder AM, Taylor NF, Dodd KJ, Shields N. Physiotherapy intervention practice patterns used in rehabilitation after distal radial fracture. Physiotherapy. 2013 Sep;99(3):233-40. doi: 10.1016/j.physio.2012.09.003. Epub 2012 Nov 30.
Background: PubMed 21684488Bruder A, Taylor NF, Dodd KJ, Shields N. Exercise reduces impairment and improves activity in people after some upper limb fractures: a systematic review. J Physiother. 2011;57(2):71-82. doi: 10.1016/S1836-9553(11)70017-0.
Background: PubMed 19345766Krischak GD, Krasteva A, Schneider F, Gulkin D, Gebhard F, Kramer M. Physiotherapy after volar plating of wrist fractures is effective using a home exercise program. Arch Phys Med Rehabil. 2009 Apr;90(4):537-44. doi: 10.1016/j.apmr.2008.09.575.
Background: PubMed 16856004Handoll HH, Madhok R, Howe TE. Rehabilitation for distal radial fractures in adults. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD003324. doi: 10.1002/14651858.CD003324.pub2.
Background: PubMed 20828988Glasgow C, Tooth LR, Fleming J. Mobilizing the stiff hand: combining theory and evidence to improve clinical outcomes. J Hand Ther. 2010 Oct-Dec;23(4):392-400; quiz 401. doi: 10.1016/j.jht.2010.05.005. Epub 2010 Sep 9.
Background: PubMed 23450213Schwartz DA. Static progressive orthoses for the upper extremity: a comprehensive literature review. Hand (N Y). 2012 Mar;7(1):10-7. doi: 10.1007/s11552-011-9380-2. Epub 2011 Dec 16.
Background: PubMed 19753120Masia L, Casadio M, Sandini G, Morasso P. Eye-hand coordination during dynamic visuomotor rotations. PLoS One. 2009 Sep 15;4(9):e7004. doi: 10.1371/journal.pone.0007004.
Background: PubMed 20174919Casadio M, Sanguineti V, Squeri V, Masia L, Morasso P. Inter-limb interference during bimanual adaptation to dynamic environments. Exp Brain Res. 2010 May;202(3):693-707. doi: 10.1007/s00221-010-2175-9. Epub 2010 Feb 20.
Background: PubMed 21096858Masia L, Squeri V, Saha D, Burdet E, Sandini G, Morasso P. Stabilizing unstable object by means of kinematic redundancy. Annu Int Conf IEEE Eng Med Biol Soc. 2010;2010:3698-702. doi: 10.1109/IEMBS.2010.5627438.
Background: PubMed 20567516Squeri V, Masia L, Casadio M, Morasso P, Vergaro E. Force-field compensation in a manual tracking task. PLoS One. 2010 Jun 17;5(6):e11189. doi: 10.1371/journal.pone.0011189.
Background: PubMed 5788487Jebsen RH, Taylor N, Trieschmann RB, Trotter MJ, Howard LA. An objective and standardized test of hand function. Arch Phys Med Rehabil. 1969 Jun;50(6):311-9. No abstract available.
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.

Paolo Catitti, MD principal investigator

Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 6 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: finished, as of the sponsor's last update on 4 Feb 2021. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change from baseline Jamar Test at 3th week (time frame: Up to 3 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04739644, which also lists 14 linked publications.

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 4 Feb 2021; AzTrials last refreshed its copy on 6 Nov 2026.