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

NCT05122273 | Unknown

• 1 other identifier: Orthos Trial
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuromuscular Diseases

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (1)

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

Interventions

Stella BIO DEVICE

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

Children and adults with confirmed neuromuscular disease

Eligibility Criteria

• Age: 3 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients with confirmed genetic Duchenne muscular dystrophy (DMD) or Becker muscular dystrophy (BMD), limb-girdle dystrophy, spinal muscular atrophy (SMA), myopathy or neuropathy

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• EGZOTech: lead

Study Sites (1)

Orthos

Warsaw, Poland

Location

MeSH Terms

Conditions

Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Central Study Contacts

Katarzyna Bienias, PhD

CONTACT

+48606276606; katarzyna.bienias@egzotech.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: November 16, 2021
• Study Start: November 20, 2021
• Primary Completion: February 1, 2022
• Study Completion: February 28, 2022
• Last Updated: November 16, 2021

Record last verified: 2021-11

Locations

PL (1)