Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| SYSNAV | INDUSTRY |
| Erasme University Hospital | OTHER |
| Queen Fabiola Children's University Hospital | OTHER |
| Centre Hospitalier Régional de la Citadelle |
Not provided
Not provided
Not provided
Acti-SMA is a multi-centric academic study. It aims to monitor the progress of patients with spinal muscular atrophy under treatment with Spinraza° or risdiplam. First, we want to quantify improvement of both ambulant and non-ambulant patients under treatment. A secondary objective would also be to identify suitable accelerometric measurements that are sensitive to change but also well correlated to other clinical scores.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SMA patients | Experimental | Patients with type 2 or 3 spinal muscular atrophy undergoing Spinraza° or risdiplam treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Actimyo | Device | Actimyo° is an innovative device intended to be used in a home-based environment. It is composed of two watch-like sensors, each containing a magneto-inertial sensors that record the linear acceleration, the angular velocity, the magnetic field of the movement in all directions.The two watches can be worn as wristwatch or placed near the ankle. |
| Measure | Description | Time Frame |
|---|---|---|
| 95th centile of stride velocity | 95th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life. (meter per second). | 39 months |
| 50th centile of stride velocity | 50th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second). | 39 months |
| 95th centile of stride length | 95th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter). | 39 months |
| 50th centile of stride length | 50th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter). | 39 months |
| Upper limb function evolution in patient with SMA undergoing treatment | Upper limb function assessed with a magneto-inertial sensor (Actimyo°) in real-life. | 39 months |
| Measure | Description | Time Frame |
|---|---|---|
| 6-minute walk test | The Six-Minute Walk Test is a functional walking test in which investigators assess the distance the patient can walk in six minutes (meter). | 39 months |
| Dynamometric measures |
Not provided
Inclusion Criteria:
Exclusion Criteria:
- Patients with excessive cognitive disorders, limiting the understanding of task or with apparent communication difficulties hindering data collection.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Margaux Poleur | CHR Citadelle-CHU liège | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Régional de la Citadelle | Liège | Liège | 4000 | Belgium | ||
| Erasme Hospital - Cliniques universitaires de Bruxelles |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009134 | Muscular Atrophy, Spinal |
| D016472 | Motor Neuron Disease |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
Not provided
Not provided
| OTHER |
all patients undergo clinical evaluation and wear Actimyo device in daily living to evaluate their improvement under treatment.
Not provided
Not provided
Not provided
Not provided
|
Assessment of upper limb strength with myogrip and myopinch (kg).
| 39 months |
| 10-metre walk test | The 10-metre walk test is a functional walking test in which investigators assess the time the patient take to walk 10 meters (second). | 39 months |
| rise from floor | The rise from floor is a functional test in which investigators assess the time the patient take to rise from the floor (second). | 39 months |
| 4-stair climb | The 4-stair climbr is a functional test in which investigators assess the time the patient take to climb a four-step staircase (second). | 39 months |
| revised upper limb module (RULM) | Revised Upper Limb Module (RULM) is an assessment specifically designed for upper limb function in Spinal Muscular Atrophy. | 39 months |
| Hamersmith funcitonnal motor scale (HFMS) | HFMS is a scale is specifically designed outcome measure for people affected by Spinal Muscular Atrophy. | 39 months |
| motor function measure (MFM) | Motor Function Measure is a global quantitative scale created to measure the functional motor abilities of a person affected by a neuromuscular disease. | 39 months |
| Brussels |
| 1000 |
| Belgium |
| National Clinical Hospital for Children Neurohabilitation "Dr Nicolae Robanescu" | Bucharest | Romania |
| D009468 | Neuromuscular Diseases |