Feasibility, Validation and Application of Digital Tools for the Follow-up of Neuromuscular Patient Mobility in Daily Living
NCT ID: NCT05798325
Last Updated: 2023-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
40 participants
INTERVENTIONAL
2023-06-29
2024-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Integration and validation of the technology in trials, research and patients' lives is essential in overcoming this hurdle. For example, in dystrophinopathies separate outcome measures exist for ambulant and non-ambulant participants, but the relation between these outcome measures or a transitional outcome measure/end point is largely missing.
Following an exhaustive literature review, several tools have been selected to remotely follow various symptoms of neuromuscular patients including weakness, pain, fatigue, cognitive defects, motor impairments (including loss of dexterity, ataxia...), metabolic, respiratory and cardiac troubles, contractures, tremor, falls, hypo or hypersomnia... The toolbox includes common measures for all patients but may include additional measures specific to the patient's symptoms (hence in turn to the patients' disease).
The measurements are designed to not be invasive, intrusive or burdensome for the patient.
DT4RD is going to leverage state-of-the art technology, clinical rating scales and psychometric/data analysis to deliver fit for purpose remote clinical assessments of mobility to ensure maximum patient benefit, specifically:
* Compare face to face clinical data collected in hospital with Patient Generated Data recorded remotely
* Examine how sensors can enhance measurement potentially at home and during clinical visits
* Promote a clear focus on user centered design and the integration of technology
* Use reliability and validity analyses to equate any common measures (those with the same or a similar construct)
* Demonstrate a proof-of-concept model into which different measures can be interchangeable
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Continuous Measurement of the Activity for Clinical Evaluation at Home, for Non-ambulant Neuromuscular Patients
NCT01611597
Gait and Paraspinal sEMG in Degenerative Spinal Diseases
NCT07309926
Motor Parameters in Patients With Limb Girdle Muscular Dystrophy
NCT04772027
Controlled Study of Upper and Lower Limb Movements in Patients Patients with Pathologies That Have an Impact on Ambulation or Motor Function
NCT06439823
EMG Analysis in ABI: Motor Imagery and Action
NCT06230718
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Principal
2MWT
Two minutes walk tests.
MFM32
Motor Function Measurement (MFM) is a quantitative scale created to measure global motor functional abilities in a person with neuromuscular disease.
MyoGrip
The MyoGrip is a dynamometer for measuring grip strength.
QOL-gNMD
The "Quality of Life in genetic Neuromuscular Disease" questionnaire (QoL-gNMD) is a patient reported outcome measure (PROM) tool specifically designed for patients with a lowly progressive neuromuscular disease with genetically predominant muscular damage
Spirometry
Forced vital capacity (FVC), peak expiratory flow (PEF) and forced expiratory volume in 1 second (FEV1) will be measured in the hospital with the local hospital device (e.g. Vitalograph) under the supervision of the clinical evaluator, and at home with a portable device.
Acceleromerty
The Links sensor system is a measuring device and consists of the Links Pods and the Links Hub. The Links pods contain an accelerometer, gyroscope and magnetometer to measure position relative to a global reference frame.
10mWT
10 meters walking Test.
PUL
The Performance of the Upper Limb (PUL) is a functional scale specifically designed for assessing upper limb function in Duchenne muscular dystrophy.
NSAA
The North Star Ambulatory Assessment (NSAA) is a 17-item rating scale that is used to measure functional motor abilities in ambulant children with Duchenne Muscular Dystrophy.
NSAD
The NSAD was developed to measure motor performance in ambulant and non-ambulant subjects as part of the clinical outcome study of dysferlinopathy.
TANS
This scale is derived from the North Star Ambulatory Assessment and several items from the Egan Klassifikation Scale (EK2).
MyoPinch
The MyoPinch is a high-precision dynamometer that allows the evaluation of key pinch strength.
MyoQuad
The MyoQuad is a high-precision dynamometer that allows the evaluation of knee extension strength.
ACTIVLIM
Activity limitations, as measured by ACTIVLIM, is defined as the difficulties a patient may have in executing daily activities, whatever the strategies involved.
PREM
This questionnaire is made up of simple questions relating to the assessments and assessment tools that were used during the study.
SF-MPQ
The main component of the SF-MPQ consists of 15 descriptors (11 sensories; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.
FSS
The Fatigue Severity Scale is used to assess the severity of fatigue and its impact on daily living. The patient responds on a Likert-type scale ranging from 1 to 7.
IPAQ
This questionnaire assesses overall physical activity and the level of sedentary lifestyle during the last seven days.
Rang of motion
The EasyAngle® is a digital goniometer improving long established goniometric functionality with rotation, inclination, and scoliosis measurement capabilities.
Goniometry
The Links sensor system is a measuring device and consists of the Links Pods and the Links Hub. The Links pods contain an accelerometer, gyroscope and magnetometer to measure position relative to a global reference frame.
Video captured monitoring
Once every four weeks, while wearing the Yumen electronic goniometers (Links Sensor System), the patients will be asked to record on video three tasks related to:
1. Upper limbs: hands to head
2. Lower limbs: Sit to stand with or without the help of a person
3. Self-defined important task: A task of the patient's choice, from a list of tasks, representative of his/her motor difficulties or hindrance to autonomy.
Activity monitoring
Wearable devices (connected watch) will collect health-related data on a 24/7 basis remotely as patients go through their daily routines at home and work.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
2MWT
Two minutes walk tests.
MFM32
Motor Function Measurement (MFM) is a quantitative scale created to measure global motor functional abilities in a person with neuromuscular disease.
MyoGrip
The MyoGrip is a dynamometer for measuring grip strength.
QOL-gNMD
The "Quality of Life in genetic Neuromuscular Disease" questionnaire (QoL-gNMD) is a patient reported outcome measure (PROM) tool specifically designed for patients with a lowly progressive neuromuscular disease with genetically predominant muscular damage
Spirometry
Forced vital capacity (FVC), peak expiratory flow (PEF) and forced expiratory volume in 1 second (FEV1) will be measured in the hospital with the local hospital device (e.g. Vitalograph) under the supervision of the clinical evaluator, and at home with a portable device.
Acceleromerty
The Links sensor system is a measuring device and consists of the Links Pods and the Links Hub. The Links pods contain an accelerometer, gyroscope and magnetometer to measure position relative to a global reference frame.
10mWT
10 meters walking Test.
PUL
The Performance of the Upper Limb (PUL) is a functional scale specifically designed for assessing upper limb function in Duchenne muscular dystrophy.
NSAA
The North Star Ambulatory Assessment (NSAA) is a 17-item rating scale that is used to measure functional motor abilities in ambulant children with Duchenne Muscular Dystrophy.
NSAD
The NSAD was developed to measure motor performance in ambulant and non-ambulant subjects as part of the clinical outcome study of dysferlinopathy.
TANS
This scale is derived from the North Star Ambulatory Assessment and several items from the Egan Klassifikation Scale (EK2).
MyoPinch
The MyoPinch is a high-precision dynamometer that allows the evaluation of key pinch strength.
MyoQuad
The MyoQuad is a high-precision dynamometer that allows the evaluation of knee extension strength.
ACTIVLIM
Activity limitations, as measured by ACTIVLIM, is defined as the difficulties a patient may have in executing daily activities, whatever the strategies involved.
PREM
This questionnaire is made up of simple questions relating to the assessments and assessment tools that were used during the study.
SF-MPQ
The main component of the SF-MPQ consists of 15 descriptors (11 sensories; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.
FSS
The Fatigue Severity Scale is used to assess the severity of fatigue and its impact on daily living. The patient responds on a Likert-type scale ranging from 1 to 7.
IPAQ
This questionnaire assesses overall physical activity and the level of sedentary lifestyle during the last seven days.
Rang of motion
The EasyAngle® is a digital goniometer improving long established goniometric functionality with rotation, inclination, and scoliosis measurement capabilities.
Goniometry
The Links sensor system is a measuring device and consists of the Links Pods and the Links Hub. The Links pods contain an accelerometer, gyroscope and magnetometer to measure position relative to a global reference frame.
Video captured monitoring
Once every four weeks, while wearing the Yumen electronic goniometers (Links Sensor System), the patients will be asked to record on video three tasks related to:
1. Upper limbs: hands to head
2. Lower limbs: Sit to stand with or without the help of a person
3. Self-defined important task: A task of the patient's choice, from a list of tasks, representative of his/her motor difficulties or hindrance to autonomy.
Activity monitoring
Wearable devices (connected watch) will collect health-related data on a 24/7 basis remotely as patients go through their daily routines at home and work.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients with a genetically confirmed/molecular-proven neuromuscular or neurometabolic disease\*
* Patients experiencing walking difficulties in the home and at high risk of limiting participation and walking outside of the home.
* Written informed consent
* Able to comply with all protocol requirements, including video recording
* Affiliated to or beneficiary of a social security scheme (for France)
Exclusion Criteria
* Patient walking 10m in less than 10s
* Guardianship/trusteeship
* Pregnant or nursing women
* Patients having relevant concomitant pathologies that, in the appreciation of the investigator could interfere with protocol compliance
* Patients not being affiliated with local social security (for France)
12 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Aparito Ltd.
INDUSTRY
Institut de Myologie, France
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Association Institut de Myologie
Paris, , France
John Walton Muscular Dystrophy Research Centre
Newcastle upon Tyne, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DT4RD
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.