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

Sponsor
EGZOTech (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05122273
Collaborator
(none)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Stella BIO

Study Design

Study Type:
Observational
Anticipated Enrollment :
8 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Assessment of the Effectiveness of Muscle Activating Training With the Use of EMG Biofeedback in Patients With Neuromuscular Diseases
Anticipated Study Start Date :
Nov 20, 2021
Anticipated Primary Completion Date :
Feb 1, 2022
Anticipated Study Completion Date :
Feb 28, 2022

Arms and Interventions

Arm Intervention/Treatment
Children and adults with confirmed neuromuscular disease

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
Individually planned therapeutic procedures, using, among others, the concept of EMG biofeedback

Outcome Measures

Primary Outcome Measures

  1. 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).

  2. Change in postural assessment by plurimeter (Rippstein) [baseline, after 12 weeks]

    Spine curvature assessment in sagittal plane

  3. 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

  4. Change in strength assessment [baseline, after 12 weeks]

    Assessment of muscle strength using electrical dynamometer MicroFET2

  5. Change in EMG assessment [baseline, after 12 weeks]

    EMG assessment using Stella BIO device

  6. 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.

  7. 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.

  8. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 25 Years
Sexes Eligible for Study:
All
Accepts 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,

Contacts and Locations

Locations

Site City State Country Postal Code
1 Orthos Warsaw Poland

Sponsors and Collaborators

  • EGZOTech

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
EGZOTech
ClinicalTrials.gov Identifier:
NCT05122273
Other Study ID Numbers:
  • Orthos Trial
First Posted:
Nov 16, 2021
Last Update Posted:
Nov 16, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 16, 2021