Robot-based Wrist Rehabilitation in Orthopaedics: Efficacy and Comparison With Traditional Methods
Primary Purpose
Wrist Injuries
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Specific wrist rehabilitation by WRISTBOT device
Specific wrist rehabilitation performed by the physiotherapist
General rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Wrist Injuries focused on measuring Adult, Humans, Middle aged, Robotics / instrumentation*, Wrist Injuries / physiopathology, Wrist Injuries / rehabilitation*
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental: WRISTBOT Group
Control group
Arm Description
The patients in the "WRISTBOT Group" underwent to following interventions: 1. General Rehabilitation 2. Specific wrist rehabilitation by WRISTBOT device
The patients in the Control Group underwent to following interventions: 1. General Rehabilitation 2. Specific wrist rehabilitation performed by physiotherapist.
Outcomes
Primary Outcome Measures
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
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
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
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
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.
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.
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).
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.
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.
Secondary Outcome Measures
Number of Recorded Side effects
Side effects using WRISTBOT device
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)
Full Information
NCT ID
NCT04739644
First Posted
January 27, 2021
Last Updated
February 1, 2021
Sponsor
Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
Collaborators
Istituto Italiano di Tecnologia
1. Study Identification
Unique Protocol Identification Number
NCT04739644
Brief Title
Robot-based Wrist Rehabilitation in Orthopaedics: Efficacy and Comparison With Traditional Methods
Official Title
Robot-based Wrist Rehabilitation After Orthopaedic Trauma: a Pilot Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 7, 2015 (Actual)
Primary Completion Date
June 14, 2018 (Actual)
Study Completion Date
June 14, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
Collaborators
Istituto Italiano di Tecnologia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wrist Injuries
Keywords
Adult, Humans, Middle aged, Robotics / instrumentation*, Wrist Injuries / physiopathology, Wrist Injuries / rehabilitation*
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study considers participants divided in two groups: the control group and the experimental group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental: WRISTBOT Group
Arm Type
Experimental
Arm Description
The patients in the "WRISTBOT Group" underwent to following interventions: 1. General Rehabilitation 2. Specific wrist rehabilitation by WRISTBOT device
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The patients in the Control Group underwent to following interventions: 1. General Rehabilitation 2. Specific wrist rehabilitation performed by physiotherapist.
Intervention Type
Device
Intervention Name(s)
Specific wrist rehabilitation by WRISTBOT device
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Specific wrist rehabilitation performed by the physiotherapist
Intervention Description
Passive, active and assisted mobilization
Intervention Type
Other
Intervention Name(s)
General rehabilitation
Intervention Description
Exercise with elastic bands or weights, exercise of manipulation and dexterity, simulation of daily life activities supervised by the physiotherapist
Primary Outcome Measure Information:
Title
Change from baseline Jamar Test at 3th week
Description
Using a hand dynamometer, subjects perform three trials to evaluate the mean static palmar force exerted in kg
Time Frame
Up to 3 weeks
Title
Change from baseline Jebsen Taylor Hand Function Test (JTHFT) at 3th week
Description
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
Time Frame
Up to 3 weeks
Title
Change from baseline Patient Rated Wrist/Hand Evaluation (PRWE) at 3th week
Description
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
Time Frame
Up to 3 weeks
Title
Change from 3th week (Te) Patient Rated Wrist/Hand Evaluation (PRWE) at the follow-up assessment after 3 months (Tf)
Description
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
Time Frame
Up to 3 months from Te
Title
Change from baseline Passive ROM (robotic assessment) at 3th week
Description
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.
Time Frame
Up to 3 weeks
Title
Change from baseline Active ROM (robotic assessment) at 3th week
Description
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.
Time Frame
Up to 3 weeks
Title
Change from baseline Isometric Force (robotic assessment) at 3th week
Description
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).
Time Frame
Up to 3 weeks
Title
Change from baseline Target Tracking (robotic assessment) at 3th week
Description
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.
Time Frame
Up to 3 weeks
Title
Change from baseline Joint Position Matching (robotic assessment) at 3th week
Description
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.
Time Frame
Up to 3 weeks
Secondary Outcome Measure Information:
Title
Number of Recorded Side effects
Description
Side effects using WRISTBOT device
Time Frame
Through study completion, up to 3 weeks
Title
Patient Satisfaction
Description
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)
Time Frame
After 3 weeks intervention (Te)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Catitti, MD
Organizational Affiliation
Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23628557
Citation
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.
Results Reference
background
PubMed Identifier
23200599
Citation
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.
Results Reference
background
PubMed Identifier
21684488
Citation
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.
Results Reference
background
PubMed Identifier
19345766
Citation
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.
Results Reference
background
PubMed Identifier
16856004
Citation
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.
Results Reference
background
PubMed Identifier
20828988
Citation
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.
Results Reference
background
PubMed Identifier
23450213
Citation
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.
Results Reference
background
PubMed Identifier
19753120
Citation
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.
Results Reference
background
PubMed Identifier
20174919
Citation
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.
Results Reference
background
PubMed Identifier
21096858
Citation
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.
Results Reference
background
PubMed Identifier
20567516
Citation
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.
Results Reference
background
PubMed Identifier
5788487
Citation
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.
Results Reference
background
PubMed Identifier
22719008
Citation
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.
Results Reference
background
PubMed Identifier
34465356
Citation
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.
Results Reference
derived
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Robot-based Wrist Rehabilitation in Orthopaedics: Efficacy and Comparison With Traditional Methods
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