Inflammatory Myopathy
Conditions
Keywords
virtual reality, robot assisted rehabilitation, dual-task intervention, randomised controlled trial
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.
Interventions
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.
OTHERStandard physical therapy
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.
Sponsors
National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Muscle strength | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional exercise capacity and aerobic fitness | change from baseline at week 4-6 and week 10-12 | 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. |
| Health Assessment Questionnaire | change from baseline at week 4-6 and week 10-12 | 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 |
| Gait analysis | change from baseline at week 4-6 and week 10-12 | 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. |
| Stance analysis | change from baseline at week 4-6 and week 10-12 | Centre of pressure path length measured with the use of Zebris® treadmill system |
| Functional exercise capacity | change from baseline at week 4-6 and week 10-12 | 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. |
| Serum activity of creatine phosphokinase | change from baseline at week 4-6 and week 10-12 | Reference range: 39-308 U/L |
| Serum activity of lactate dehydrogenase | change from baseline at week 4-6 and week 10-12 | Reference rage: 135-225 U/L |
| Serum activity of C reactive protein | change from baseline at week 4-6 and week 10-12 | Reference range: \< 5 mg/L |
| Patient Global Activity | change from baseline at week 4-6 and week 10-12 | 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 |
| Self-reported quality of life | change from baseline at week 4-6 and week 10-12 | 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. |
| Depression, Anxiety, Stress | change from baseline at week 4-6 and week 10-12 | 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. |
| Fatigue | change from baseline at week 4-6 and week 10-12 | 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 |
| Pain coping strategies | change from baseline at week 4-6 and week 10-12 | 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. |
| Personality domains | baseline | 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. |
Countries
Poland
Contacts
PRINCIPAL_INVESTIGATORAleksandra Markowska
National Institute of Geriatrics, Rheumatology and Rehabilitation
PRINCIPAL_INVESTIGATORBeata Tarnacka, Professor
National Institute of Geriatrics, Rheumatology and Rehabilitation
PRINCIPAL_INVESTIGATORJustyna Frasuńska, PhD
National Institute of Geriatrics, Rheumatology and Rehabilitation
Outcome results
None listed