Clinical trial NCT04739644: 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
Overall status: COMPLETED
Phase: NA
Conditions: Wrist Injuries
Keywords: Adult
Humans
Middle aged
Robotics / instrumentation*
Wrist Injuries / physiopathology
Wrist Injuries / rehabilitation*
Lead sponsor: Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
Sponsor class: OTHER
Collaborators: name: Istituto Italiano di Tecnologia
First posted: 2021-02-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study considers participants divided in two groups: the control group and the experimental group
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline Jamar Test at 3th week
timeFrame: Up to 3 weeks
measure: Change from baseline Jebsen Taylor Hand Function Test (JTHFT) at 3th week
timeFrame: Up to 3 weeks
measure: Change from baseline Patient Rated Wrist/Hand Evaluation (PRWE) at 3th week
timeFrame: Up to 3 weeks
measure: Change from 3th week (Te) Patient Rated Wrist/Hand Evaluation (PRWE) at the follow-up assessment after 3 months (Tf)
timeFrame: Up to 3 months from Te
measure: Change from baseline Passive ROM (robotic assessment) at 3th week
timeFrame: Up to 3 weeks
measure: Change from baseline Active ROM (robotic assessment) at 3th week
timeFrame: Up to 3 weeks
measure: Change from baseline Isometric Force (robotic assessment) at 3th week
timeFrame: Up to 3 weeks
measure: Change from baseline Target Tracking (robotic assessment) at 3th week
timeFrame: Up to 3 weeks
measure: Change from baseline Joint Position Matching (robotic assessment) at 3th week
timeFrame: Up to 3 weeks
Secondary outcomes:
measure: Number of Recorded Side effects
timeFrame: Through study completion, up to 3 weeks
measure: Patient Satisfaction
timeFrame: After 3 weeks intervention (Te)
Other outcomes:
Locations:
Study officials:
affiliation: Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
name: Paolo Catitti, MD
role: PRINCIPAL_INVESTIGATOR
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