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

study id #: NCT05122273

condition: Neuromuscular Diseases

status: Not yet recruiting

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.

intervention: Stella BIO

results: https://clinicaltrials.gov/ct2/show/results/NCT05122273

last updated: February 04, 2022

start date: November 20, 2021

estimated completion: February 28, 2022

last updated: November 16, 2021

size / enrollment: 8

primary outcomes:

• 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
  

inclusion criteria:

exclusion criteria: 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,

sponsor: EGZOTech

contacts: Katarzyna Bienias, PhD, +48606276606, katarzyna.bienias@egzotech.com

trial center locations: Poland

• Assessment of the Effectiveness of Muscle Activating Training With the Use of EMG Biofeedback in Patients With Neuromuscular Diseases
  Agnieszka Stępień, PhD