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

• Conditions: Neuromuscular Diseases
• Interventions: Device: Stella BIO

• Registration Number: NCT05122273
• Lead Sponsor: EGZOTech

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-01
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-14
• Last Update Submitted: 2021-11-14
• Study First Posted: 2021-11-16
• Last Update Posted: 2021-11-16
• Study Start: 2021-11-20
• Primary Completion: 2022-02-01
• Study Completion: 2022-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children and adults with confirmed neuromuscular disease	Stella BIO	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.

Primary Outcome Measures

Name	Time	Method
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
Change in strength assessment	baseline, after 12 weeks	Assessment of muscle strength using electrical dynamometer MicroFET2
Change in postural assessment by plurimeter (Rippstein)	baseline, after 12 weeks	Spine curvature assessment in sagittal plane
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).
Change in EMG assessment	baseline, after 12 weeks	EMG assessment using Stella BIO device
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.
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.
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.

Trial Locations

Locations (1)

Orthos; 🇵🇱 Warsaw, Poland