Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-immersive virtual reality based rehabilitation | Experimental |
| |
| Standard physical therapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Functional exercise capacity and aerobic fitness | Ergospirometry assesses maximal oxygen uptake (VOāmax), defined as the maximum amount of oxygen consumed per minute per kilogram of body weight (mL/kg/min). A higher VOāmax reflects greater aerobic fitness and functional exercise capacity. | change from baseline at week 4-6 and week 10-12 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Aleksandra Markowska | National Institute of Geriatrics, Rheumatology and Rehabilitation | Principal Investigator |
| Beata Tarnacka, Professor | National Institute of Geriatrics, Rheumatology and Rehabilitation | Principal Investigator |
| Justyna FrasuÅska, PhD | National Institute of Geriatrics, Rheumatology and Rehabilitation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Geriatrics, Rheumatology and Rehabilitation | Warsaw | Poland |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009220 | Myositis |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 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 |
| change from baseline at week 4-6 and week 10-12 |
| Gait analysis | Gait analysis is performed on a force-sensing ZebrisĀ® treadmill. Step length, stride length, cadence, velocity, step time, stride time, single limb support are measured. | change from baseline at week 4-6 and week 10-12 |
| Stance analysis | Centre of pressure path length measured with the use of ZebrisĀ® treadmill system | 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. | change from baseline at week 4-6 and week 10-12 |
| Serum activity of creatine phosphokinase | Reference range: 39-308 U/L | change from baseline at week 4-6 and week 10-12 |
| Serum activity of lactate dehydrogenase | Reference rage: 135-225 U/L | change from baseline at week 4-6 and week 10-12 |
| Serum activity of C reactive protein | Reference range: < 5 mg/L | 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 | 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. | 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. | 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 | 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. | 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. | baseline |