Neuromuscular Diseases
Conditions
Brief summary
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.
Interventions
DEVICEStella BIO
Individually planned therapeutic procedures, using, among others, the concept of EMG biofeedback
Sponsors
EGZOTech
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Years to 25 Years
Healthy volunteers
No
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,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in functional assessment | baseline, after 12 weeks | 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). |
| Change in postural assessment by plurimeter (Rippstein) | baseline, after 12 weeks | Spine curvature assessment in sagittal plane |
| Change in range of motion in upper and lower limb by goniometer | baseline, after 12 weeks | Assessment of the changes in the range of motion in joints in the upper and lower limb measured by goniometer |
| Change in strength assessment | baseline, after 12 weeks | Assessment of muscle strength using electrical dynamometer MicroFET2 |
| Change in EMG assessment | baseline, after 12 weeks | EMG assessment using Stella BIO device |
| Hammersmith Functional Motor Scale Expanded | baseline, after 12 weeks | 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. |
| North Star Ambulatory Assessment | baseline, after 12 weeks | 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. |
| Change in postural assessment by scoliometer | baseline, after 12 weeks | 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. |
Countries
Poland
Contacts
Primary ContactKatarzyna Bienias, PhD
Outcome results
None listed