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Clinical Trials/NCT05122273
NCT05122273
Unknown
Not Applicable

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

EGZOTech1 site in 1 country8 target enrollmentNovember 20, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neuromuscular Diseases
Sponsor
EGZOTech
Enrollment
8
Locations
1
Primary Endpoint
Change in range of motion in upper and lower limb by goniometer
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 20, 2021
End Date
February 28, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
EGZOTech
Responsible Party
Sponsor

Eligibility Criteria

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,

Outcomes

Primary Outcomes

Change in range of motion in upper and lower limb by goniometer

Time Frame: 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

Time Frame: baseline, after 12 weeks

Assessment of muscle strength using electrical dynamometer MicroFET2

Change in postural assessment by plurimeter (Rippstein)

Time Frame: baseline, after 12 weeks

Spine curvature assessment in sagittal plane

Change in functional assessment

Time Frame: 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 EMG assessment

Time Frame: baseline, after 12 weeks

EMG assessment using Stella BIO device

Hammersmith Functional Motor Scale Expanded

Time Frame: 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.

Change in postural assessment by scoliometer

Time Frame: 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.

North Star Ambulatory Assessment

Time Frame: 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.

Study Sites (1)

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