Virtual Reality and Robotics in Inflammatory Myopathy Rehabilitation

NCT06968819 | Completed

• 1 other identifier: nigrr_myopathy
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inflammatory Myopathy

Keywords

virtual reality; robot assisted rehabilitation; dual-task intervention; randomised controlled trial

Outcome Measures

Primary Outcomes (2)

• Muscle strength

  The Manual Muscle Testing (MMT-8) evaluates the strength of eight designated muscle groups: Deltoid, Biceps, Wrist extensors, Quadriceps, Ankle dorsiflexors, Neck flexors, Gluteus medius, and Gluteus maximus. Each muscle group is rated on a scale from 0 to 10 points, with the total score ranging from 0 to 150.

  change from baseline at week 4-6 and week 10-12

• Muscle endurance

  The Functional Index-3 (FI-3) involves the assessment of the number of repetitions of shoulder flexion, neck flexion, and hip flexion. Maximum number of repetitions for shoulder flexion and hip flexion is 60 each. Maximum number of repetitions for neck flexion is 30. The total score (summation of the individual tasks divided by 3) ranges from 0 to 50.

  change from baseline at week 4-6 and week 10-12

Secondary Outcomes (14)

• Functional exercise capacity and aerobic fitness

  change from baseline at week 4-6 and week 10-12

• Health Assessment Questionnaire

  change from baseline at week 4-6 and week 10-12

• Gait analysis

  change from baseline at week 4-6 and week 10-12

• Stance analysis

  change from baseline at week 4-6 and week 10-12

• Functional exercise capacity

  change from baseline at week 4-6 and week 10-12

Study Arms (2)

Non-immersive virtual reality based rehabilitation

EXPERIMENTAL

Other: Non-immersive virtual reality

Standard physical therapy

ACTIVE COMPARATOR

Other: Standard physical therapy

Interventions

Non-immersive virtual reality OTHER

Non-immersive virtual reality-based robot-assisted intervention includes balance and coordination training, muscle strengthening exercises as well as cognitive stimulation activities on an interactive treadmill, stabilometric platform and robot-assisted upper limb rehabilitation device. In addition, the experimental group takes part in group sessions featuring active and isometric exercises or motor coordination training.

Non-immersive virtual reality based rehabilitation

Standard physical therapy OTHER

Participants receive standard physical therapy, which includes individual sessions focused on muscle strengthening, balance training, stretching, suspension therapy, and treadmill exercises. In addition, they take part in group sessions featuring active, isometric exercises or motor coordination training.

Standard physical therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 y.o,
• reduced muscular strength defined by ≤ 64/80 result in MMT-8 and/or ≤ 7/10 result in MMT in ≥ 1 proximal muscle group

You may not qualify if:

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

Sponsors & Collaborators

• National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland: lead

Study Sites (1)

National Institute of Geriatrics, Rheumatology and Rehabilitation

Warsaw, Poland

Location

MeSH Terms

Conditions

Myositis

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Aleksandra Markowska

  National Institute of Geriatrics, Rheumatology and Rehabilitation

  PRINCIPAL INVESTIGATOR

• Beata Tarnacka, Professor

  National Institute of Geriatrics, Rheumatology and Rehabilitation

  PRINCIPAL INVESTIGATOR

• Justyna Frasuńska, PhD

  National Institute of Geriatrics, Rheumatology and Rehabilitation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: May 13, 2025
• Study Start: February 11, 2025
• Primary Completion: March 27, 2026
• Study Completion: March 27, 2026
• Last Updated: April 1, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)