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

Neuromuscular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05122273
• Other study ID #: Orthos Trial
• Status: Not yet recruiting
• Start date: November 20, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: November 2021
• Source: EGZOTech
• Contact: Katarzyna Bienias, PhD
• Phone: +48606276606
• Email: katarzyna.bienias[@]egzotech.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 8
• Est. completion date: February 28, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 25 Years

Eligibility

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,

Related Conditions & MeSH terms

• Neuromuscular Diseases

Intervention

Device:
• Stella BIO
Individually planned therapeutic procedures, using, among others, the concept of EMG biofeedback

Locations

Country	Name	City	State
Poland	Orthos	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
EGZOTech

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in postural assessment by plurimeter (Rippstein)	Spine curvature assessment in sagittal plane	baseline, after 12 weeks
Primary	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
Primary	Change in strength assessment	Assessment of muscle strength using electrical dynamometer MicroFET2	baseline, after 12 weeks
Primary	Change in EMG assessment	EMG assessment using Stella BIO device	baseline, after 12 weeks
Primary	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
Primary	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
Primary	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