Assessment of the Effectiveness of Muscle Activating Training With the Use of EMG Biofeedback in Patients With Neuromuscular Diseases

Study Overview
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Brief Summary
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The aim of this study is to assess the impact of individually planned therapeutic procedures, using, among others, the concept of EMG biofeedback, to improve the general functional state, selected motor activities, stimulation and strength of specific muscle syndromes as well as postural parameters in children, adolescents and adults with neuromuscular diseases.

Official Title
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Assessment of the Effectiveness of Muscle Activating Training With the Use of EMG Biofeedback in Patients With Neuromuscular Diseases

Conditions
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Neuromuscular Diseases

Intervention / Treatment
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* Device: Stella BIO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: confirmed genetic Duchenne muscular dystrophy (DMD) or Becker muscular dystrophy (BMD), limb-girdle dystrophy, spinal muscular atrophy (SMA), myopathy or neuropathy continued/uninterrupted rehabilitation process for 3 months patient's condition allowing full understanding of commands Exclusion Criteria: patients using a respirator painful complaints after injuries and fractures in the last 6 months significant weakening of muscle strength, preventing movements and activation of selected muscle groups, visible in the EMG examination cognitive impairment-lack of or poor cooperation between the patient and the therapist,

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children and adults with confirmed neuromuscular disease<br>Children and adults with confirmed genetic Duchenne muscular dystrophy (DMD) or Becker muscular dystrophy (BMD), limb-girdle dystrophy, spinal muscular atrophy (SMA), myopathy or neuropathy. | Device: Stella BIO<br>* Individually planned therapeutic procedures, using, among others, the concept of EMG biofeedback<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in functional assessment | Motor Function Measure Scale Each MFM32 item is scored on a 4-point Likert scale from 0 (cannot initiate the task) to 3 (performs the task fully). Item scores are summed, and the raw score is transformed to an overall total score ranging from 0 (severe functional impairment) to 100 (no functional impairment). | baseline, after 12 weeks | 
| Change in postural assessment by plurimeter (Rippstein) | Spine curvature assessment in sagittal plane | baseline, after 12 weeks | 
| Change in range of motion in upper and lower limb by goniometer | Assessment of the changes in the range of motion in joints in the upper and lower limb measured by goniometer | baseline, after 12 weeks | 
| Change in strength assessment | Assessment of muscle strength using electrical dynamometer MicroFET2 | baseline, after 12 weeks | 
| Change in EMG assessment | EMG assessment using Stella BIO device | baseline, after 12 weeks | 
| Hammersmith Functional Motor Scale Expanded | It contains 33 items which are scored on a scale of 0, 1, 2 with a total achievable score of 66. Score 2 = performs without modification/adaptation/compensation Score 1 = performs with modification/adaptation/compensation Score 0 = unable to perform A total score can be achieved by summing the scores for all the individual items. The total score can range from 0, if all the activities are failed, to 66, if all the activities are achieved. | baseline, after 12 weeks | 
| North Star Ambulatory Assessment | 17-item rating scale that is used to measure functional motor abilities in ambulant children with Duchenne Muscular Dystrophy. The activities are graded as follows: 2 - Normal - no obvious modification of activity 1 - Modified method but achieves goal independent of physical assistance from another 0 - Unable to achieve independently This scale is ordinal with 34 as the maximum score indicating fully-independent function. | baseline, after 12 weeks | 
| Change in postural assessment by scoliometer | Assessment of the angle of the torso rotation in a sitting or standing position; Referral for scoliosis when rib slopeAngle of trunk rotation [ATR]is : 8 degrees for underweight patients, 7 degrees for normal-weight patients, 6 degrees for overweight patients, and 5 degrees for obese patients. | baseline, after 12 weeks |