NCT04739644

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Wrist Injuries

Interventions

Type	Name	Description
DEVICE	Specific wrist rehabilitation by WRISTBOT device	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.
OTHER	Specific wrist rehabilitation performed by the physiotherapist	Passive, active and assisted mobilization
OTHER	General rehabilitation	Exercise with elastic bands or weights, exercise of manipulation and dexterity, simulation of daily life activities supervised by the physiotherapist

Timeline

• Start date: 2015-01-07
• Primary completion: 2018-06-14
• Completion: 2018-06-14
• First posted: 2021-02-04
• Last updated: 2021-02-04