Neuromuscular DiseasesNCT05122273
Assessment of the Effectiveness of Muscle Activating Training With the Use of EMG Biofeedback in Patients With Neuromuscular Diseases
An observational study of Neuromuscular Diseases, run by EGZOTech at 1 site in Poland.
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… Read more about this study
- Who is it for?
- Ages 3 to 25 years
- Conditions the study is for
- Neuromuscular Diseases
- What is being tested?
- Stella BIO
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- 1 sitePoland
- Study dates
- 20 Nov 2021to 28 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- 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
Who cannot join
- 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,
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Stella BIO
- Medical subject headings
- Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stella BIODevice
Individually planned therapeutic procedures, using, among others, the concept of EMG biofeedback
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Stella BIO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: baseline, after 12 weeks
Change in postural assessment by plurimeter (Rippstein)
Spine curvature assessment in sagittal plane
Measured: 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
Measured: baseline, after 12 weeks
Change in strength assessment
Assessment of muscle strength using electrical dynamometer MicroFET2
Measured: baseline, after 12 weeks
Change in EMG assessment
EMG assessment using Stella BIO device
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start20 Nov 2021 (estimated)
- Primary completion1 Feb 2022 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EGZOTech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05122273
- Sponsor's protocol ID
- Orthos Trial
- Status last verified
- Nov 2021
- First submitted
- 1 Sep 2021
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effectiveness of Muscle Activating Training With the Use of EMG Biofeedback in Patients With Neuromuscular Diseases
- ClinicalTrials.gov ID
- NCT05122273
- Acronym / sponsor ID
- Orthos Trial
- Conditions
- Neuromuscular Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- EGZOTechIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2021 (estimated)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children and adults with confirmed neuromuscular disease | – | Device: Stella BIOChildren and adults with confirmed genetic Duchenne muscular dystrophy (DMD) or Becker muscular dystrophy (BMD), limb-girdle dystrophy, spinal muscular atrophy (SMA), myopathy or neuropathy. |
Who may qualify
- Ages
- 3 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stella BIOIndividually planned therapeutic procedures, using, among others, the concept of EMG biofeedback | Device | Children and adults with confirmed neuromuscular disease |
Primary outcome
Change in functional assessment
Time frame: 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 postural assessment by plurimeter (Rippstein)
Time frame: baseline, after 12 weeks
Spine curvature assessment in sagittal plane
Change in range of motion in upper and lower limb by goniometer
Time frame: 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
Time frame: baseline, after 12 weeks
Assessment of muscle strength using electrical dynamometer MicroFET2
Change in EMG assessment
Time frame: baseline, after 12 weeks
EMG assessment using Stella BIO device
Hammersmith Functional Motor Scale Expanded
Time frame: 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.
North Star Ambulatory Assessment
Time frame: 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.
Change in postural assessment by scoliometer
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
Related trials for Neuromuscular Diseases
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Active, not recruitingPhase 4
A Study Evaluating the Effectiveness and Safety of Risdiplam Administered as an Early Intervention in Pediatric Participants With Spinal Muscular Atrophy After Gene Therapy
Muscular Atrophy, Spinal
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Diseases, run by EGZOTech at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katarzyna Bienias, PhD (+48606276606, katarzyna.bienias@egzotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in functional assessment (time frame: baseline, after 12 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2021.