Virtual Reality and Robotics in Inflammatory Myopathy Rehabilitation

National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland

Status: Enrolling

Conditions: Inflammatory Myopathy

Treatments: Other: Non-immersive virtual reality; Other: Standard physical therapy

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT06968819

nigrr_myopathy

Details and patient eligibility

About

The goal of this clinical trial is to learn if a virtual reality based robot assisted dual task intervention leads to better rehabilitation effects than standard physical therapy in patients with inflammatory myopathy. The main question it aims to answer is whether a non-immersive virtual reality based rehabilitation improves muscular strength and relieves psychological distress to a greater extent than standard physical therapy conducted by physiotherapists.

• Participants will be divided into intervention and control group.
• The control group will participate in a standard rehabilitation program consisting of exercise sessions with physiotherapists.
• The intervention group will train on the robotic devices (Zebris treadmill, Alfa stabilometric platform, Diego robotic set).
• Both group will train from 4 to 6 weeks, 5 times a week.
• 6 weeks after completing the rehabilitation program, patients will return for a follow-up assessement.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age ≥ 18 y.o,
• meeting the Bohan/Peter criteria for myositis or the ENMC criteria for immune-mediated necrotising myopathy and for inclusion body myositis,
• reduced muscular strength defined by ≤ 64/80 result in MMT-8 and/or ≤ 7/10 result in MMT in ≥ 1 proximal muscle group

Exclusion criteria

• severe cardiopulmonary diseases,
• concurrent malignancies,
• severe psychiatric disorders
• injuries and comorbidities preventing exercise participation

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Non-immersive virtual reality based rehabilitation

Experimental group

Treatment:

Other: Non-immersive virtual reality

Standard physical therapy

Active Comparator group

Treatment:

Other: Standard physical therapy