Inflammatory MyopathyNCT06968819
Virtual Reality and Robotics in Inflammatory Myopathy Rehabilitation
A study testing Non-immersive virtual reality and Standard physical therapy in people with Inflammatory Myopathy, run by National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Myopathy
- What is being tested?
- Non-immersive virtual reality and Standard physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 sitePoland
- Study dates
- 11 Feb 2025to 27 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- severe cardiopulmonary diseases,
- concurrent malignancies,
- severe psychiatric disorders
- injuries and comorbidities preventing exercise participation
Trial locations and contacts
1 site in 1 country.
Poland1 site
National Institute of Geriatrics, Rheumatology and Rehabilitation
Warsaw
About this study
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
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
- Being tested
- Non-immersive virtual reality, Standard physical therapy
- Keywords
- virtual reality, robot assisted rehabilitation, dual-task intervention, randomised controlled trial
- Medical subject headings
- Myositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-immersive virtual realityOther
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.
Standard physical therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Non-immersive virtual reality based rehabilitation | Experimental | Not described Receives: Other: Non-immersive virtual reality |
| Standard physical therapy | Active comparator | Not described Receives: Other: Standard physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: change from baseline at week 4-6 and week 10-12
Secondary outcomes (14)
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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: change from baseline at week 4-6 and week 10-12
Serum activity of creatine phosphokinase
Reference range: 39-308 U/L
Measured: change from baseline at week 4-6 and week 10-12
Serum activity of lactate dehydrogenase
Reference rage: 135-225 U/L
Measured: change from baseline at week 4-6 and week 10-12
Serum activity of C reactive protein
Reference range: < 5 mg/L
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start11 Feb 2025
- Primary completion27 Mar 2026
- Study completion27 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory MyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Aleksandra Markowska, Principal investigator, National Institute of Geriatrics, Rheumatology and RehabilitationBeata Tarnacka, Professor, Principal investigator, National Institute of Geriatrics, Rheumatology and RehabilitationJustyna Frasuńska, PhD, Principal investigator, National Institute of Geriatrics, Rheumatology and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968819
- Sponsor's protocol ID
- nigrr_myopathy
- Status last verified
- May 2025
- First submitted
- 18 Apr 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06968819
- Acronym / sponsor ID
- nigrr_myopathy
- Conditions
- Inflammatory Myopathy
- Keywords
- virtual reality, robot assisted rehabilitation, dual-task intervention, randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- National Institute of Geriatrics, Rheumatology and Rehabilitation, PolandResearch network
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 27 Mar 2026 (actual)
- Study completion
- 27 Mar 2026 (actual)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-immersive virtual reality based rehabilitation | Experimental | Other: Non-immersive virtual reality |
| Standard physical therapy | Active comparator | Other: Standard physical therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- severe cardiopulmonary diseases,
- concurrent malignancies,
- severe psychiatric disorders
- injuries and comorbidities preventing exercise participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-immersive virtual realityNon-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. | Other | Non-immersive virtual reality based rehabilitation |
| Standard physical therapyParticipants 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. | Other | Standard physical therapy |
Primary outcome
Muscle strength
Time frame: change from baseline at week 4-6 and week 10-12
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.
Muscle endurance
Time frame: change from baseline at week 4-6 and week 10-12
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.
14 secondary outcomes
Functional exercise capacity and aerobic fitness
Time frame: change from baseline at week 4-6 and week 10-12
Health Assessment Questionnaire
Time frame: change from baseline at week 4-6 and week 10-12
Gait analysis
Time frame: change from baseline at week 4-6 and week 10-12
Stance analysis
Time frame: change from baseline at week 4-6 and week 10-12
Functional exercise capacity
Time frame: change from baseline at week 4-6 and week 10-12
Serum activity of creatine phosphokinase
Time frame: change from baseline at week 4-6 and week 10-12
Serum activity of lactate dehydrogenase
Time frame: change from baseline at week 4-6 and week 10-12
Serum activity of C reactive protein
Time frame: change from baseline at week 4-6 and week 10-12
Patient Global Activity
Time frame: change from baseline at week 4-6 and week 10-12
Self-reported quality of life
Time frame: change from baseline at week 4-6 and week 10-12
Depression, Anxiety, Stress
Time frame: change from baseline at week 4-6 and week 10-12
Fatigue
Time frame: change from baseline at week 4-6 and week 10-12
Pain coping strategies
Time frame: change from baseline at week 4-6 and week 10-12
Personality domains
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Inflammatory Myopathy
RecruitingPhase 2
FAST for DM - Fatty Acid Supplementation Trial (FAST) for Dermatomyositis (DM)
Dermatomyositis (DM), Juvenile Dermatomyositis (JDM)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Active, not recruitingPhase 2/3
A Study of Andecaliximab in Participants With Fibrodysplasia Ossificans Progressiva (FOP)
Fibrodysplasia Ossificans Progressiva
Active, not recruitingPhase 2
A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis
Dermatomyositis, Myositis
RecruitingObservational study
Natural History of Inflammatory Muscle Diseases
Inflammation In Skeletal Muscle
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aleksandra Markowska principal investigator
National Institute of Geriatrics, Rheumatology and Rehabilitation
Beata Tarnacka, Professor principal investigator
National Institute of Geriatrics, Rheumatology and Rehabilitation
Justyna Frasuńska, PhD principal investigator
National Institute of Geriatrics, Rheumatology and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-immersive virtual reality and Standard physical therapy in people with Inflammatory Myopathy, run by National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle strength (time frame: change from baseline at week 4-6 and week 10-12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.