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

Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro

Status: Completed

Conditions: Wrist Injuries

Treatments: Other: General rehabilitation; Device: Specific wrist rehabilitation by WRISTBOT device; Other: Specific wrist rehabilitation performed by the physiotherapist

Study type: Interventional

Funder types: Other

Identifiers

NCT04739644

CRMINAIL03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Experimental: WRISTBOT Group

Experimental group

Description:

The patients in the "WRISTBOT Group" underwent to following interventions: 1. General Rehabilitation 2. Specific wrist rehabilitation by WRISTBOT device

Treatment:

Other: General rehabilitation

Device: Specific wrist rehabilitation by WRISTBOT device

Control group

Active Comparator group

Description:

The patients in the Control Group underwent to following interventions: 1. General Rehabilitation 2. Specific wrist rehabilitation performed by physiotherapist.

Treatment:

Other: General rehabilitation

Other: Specific wrist rehabilitation performed by the physiotherapist