An interventional study of Non-immersive virtual reality and Standard physical therapy in Inflammatory Myopathy, sponsored by National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland. Completed at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-01.
Sponsored by National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland · Not applicable, Interventional, and Other
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.
242 studies on the registry are indexed under Myositis; 103 are open to participants now.
This study's enrollment of 33 is close to the median of 30 across 159 interventional studies indexed under Myositis.
Browse Myositis studies →National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland is the lead sponsor of 9 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Other: Non-immersive virtual reality
Other: Standard physical therapy
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.
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.
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.
Time frame: 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.
Time frame: change from baseline at week 4-6 and week 10-12
Functional exercise capacity and aerobic fitness
Ergospirometry assesses maximal oxygen uptake (VO₂max), defined as the maximum amount of oxygen consumed per minute per kilogram of body weight (mL/kg/min). A higher VO₂max reflects greater aerobic fitness and functional exercise capacity.
Time frame: change from baseline at week 4-6 and week 10-12
Health Assessment Questionnaire
Self-assessment tool to measure the functional status. The score ranges from 0 to 3, where 0 indicates no difficulty in performing daily physical activities, and 3 indicates an inability to perform them
Time frame: change from baseline at week 4-6 and week 10-12
Gait analysis
Gait analysis is performed on a force-sensing Zebris® treadmill. Step length, stride length, cadence, velocity, step time, stride time, single limb support are measured.
Time frame: change from baseline at week 4-6 and week 10-12
Stance analysis
Centre of pressure path length measured with the use of Zebris® treadmill system
Time frame: change from baseline at week 4-6 and week 10-12
Functional exercise capacity
In a Six Minute Walk Test (6MWT) a total distance walked by a patient (in meters) is recorded. A greater distance covered indicates better physical performance and higher functional capacity.
Time frame: change from baseline at week 4-6 and week 10-12
Serum activity of creatine phosphokinase
Reference range: 39-308 U/L
Time frame: change from baseline at week 4-6 and week 10-12
Serum activity of lactate dehydrogenase
Reference rage: 135-225 U/L
Time frame: change from baseline at week 4-6 and week 10-12
Serum activity of C reactive protein
Reference range: \< 5 mg/L
Time frame: change from baseline at week 4-6 and week 10-12
Patient Global Activity
self-assessment tool to measure patient's overall disease activity using a 10 cm visual analogue scale where 0 cm indicates no evidence of disease activity and 10 cm indicates extremely active or severe disease activity
Time frame: change from baseline at week 4-6 and week 10-12
Self-reported quality of life
The WHOQOL-BREF questionnaire is used for self-assessment across four domains: physical health, psychological health, social relationships, and environment. Each item is scored from 1 (very unhappy) to 5 (very happy). Total score ranges from 0 to 100.
Time frame: change from baseline at week 4-6 and week 10-12
Depression, Anxiety, Stress
DASS-42 (depression, anxiety, stress scale). The score in each category (depression, anxiety, stress) ranges from 0 to 42. A higher score is an indicator of greater intensity of the assessed trait.
Time frame: change from baseline at week 4-6 and week 10-12
Fatigue
Modified Fatigue Impact Scale (MFIS): the score ranges from 0 to 84, where 0 indicates the lowest level of fatigue and 84 indicates the highest level of fatigue
Time frame: change from baseline at week 4-6 and week 10-12
Pain coping strategies
Pain coping strategies questionnaire (CSQ), the score in each strategy (distraction, re-evaluation of pain, catastrophizing, ignoring sensations, praying/hoping, declaring coping, increased behavioral activity) ranges from 0 to 6. The higher the score, the greater the importance attributed to the given coping strategy for pain.
Time frame: change from baseline at week 4-6 and week 10-12
Personality domains
Big Five Inventory questionnaire (BFI-2) is used to assess 5 personality domains: extraversion, agreeableness, conscientiousness, neuroticism and openness. Each statement is rated from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate a greater tendency toward that personality trait.
Time frame: baseline
Plan to share: No
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National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland