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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neuromuscular Diseases
• Intervention / Treatment: Device: Stella BIO

• Study Type: Observational
• Enrollment (Anticipated): 8

Contacts and Locations

• Study Contact: Name: Katarzyna Bienias, PhD; Phone Number: +48606276606; Email: katarzyna.bienias@egzotech.com

Study Locations

• Poland
  • Warsaw, Poland
    • Orthos
    • Contact: Agnieszka Stępień, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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,

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: EGZOTech

Study record dates

Study Major Dates

• Study Start (Anticipated): November 20, 2021
• Primary Completion (Anticipated): February 1, 2022
• Study Completion (Anticipated): February 28, 2022

Study Registration Dates

• First Submitted: September 1, 2021
• First Submitted That Met QC Criteria: November 14, 2021
• First Posted (Actual): November 16, 2021

Study Record Updates

• Last Update Posted (Actual): November 16, 2021
• Last Update Submitted That Met QC Criteria: November 14, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases
• Other Study ID Numbers: Orthos Trial

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No