Clinical trial NCT06968819: Virtual Reality and Robotics in Inflammatory Myopathy Rehabilitation
Official title: The Effect of a Virtual Reality-Based Robot-Assisted Dual-Task Intervention on Motor Rehabilitation and Psychological Distress in Patients With Inflammatory Myopathy: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inflammatory Myopathy
Keywords: virtual reality
robot assisted rehabilitation
dual-task intervention
randomised controlled trial
Lead sponsor: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
Sponsor class: NETWORK
First posted: 2025-05-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Muscle strength
timeFrame: change from baseline at week 4-6 and week 10-12
measure: Muscle endurance
timeFrame: change from baseline at week 4-6 and week 10-12
Secondary outcomes:
measure: Functional exercise capacity and aerobic fitness
timeFrame: change from baseline at week 4-6 and week 10-12
measure: Health Assessment Questionnaire
timeFrame: change from baseline at week 4-6 and week 10-12
measure: Gait analysis
timeFrame: change from baseline at week 4-6 and week 10-12
measure: Stance analysis
timeFrame: change from baseline at week 4-6 and week 10-12
measure: Functional exercise capacity
timeFrame: change from baseline at week 4-6 and week 10-12
measure: Serum activity of creatine phosphokinase
timeFrame: change from baseline at week 4-6 and week 10-12
measure: Serum activity of lactate dehydrogenase
timeFrame: change from baseline at week 4-6 and week 10-12
measure: Serum activity of C reactive protein
timeFrame: change from baseline at week 4-6 and week 10-12
measure: Patient Global Activity
timeFrame: change from baseline at week 4-6 and week 10-12
measure: Self-reported quality of life
timeFrame: change from baseline at week 4-6 and week 10-12
measure: Depression, Anxiety, Stress
timeFrame: change from baseline at week 4-6 and week 10-12
measure: Fatigue
timeFrame: change from baseline at week 4-6 and week 10-12
measure: Pain coping strategies
timeFrame: change from baseline at week 4-6 and week 10-12
measure: Personality domains
timeFrame: baseline
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: National Institute of Geriatrics, Rheumatology and Rehabilitation
Study officials:
affiliation: National Institute of Geriatrics, Rheumatology and Rehabilitation
name: Aleksandra Markowska
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of Geriatrics, Rheumatology and Rehabilitation
name: Beata Tarnacka, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of Geriatrics, Rheumatology and Rehabilitation
name: Justyna Frasuńska, PhD
role: PRINCIPAL_INVESTIGATOR
References: