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| Name | Class |
|---|---|
| University Hospital, Lille | OTHER |
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The goal of this clinical trial is to compare home based rehalitation program with real time biofeeback versus conventional physiotherapy on the gait velocity in Parkinson disease. The main question[s] it aims to answer are:
• How do the interventions afftect the gait velocity of the participants at week 12 ? Participants will be randomized to either follow prescribtional physiotherapy or FeetMe rehabilitation programs during the first 12 weeks.
At the end of 12 weeks, participants will choose in which arm they want to pursue for 12 aditionnal weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FeetMe Rehabilitation arm | Experimental |
| |
| Conventional physiotherapy arm | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FeetMe rehabilitation | Device | Home based rehabilitation program with real time biofeedback using a connected device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gait velocity | Change from baseline to Week 12 (Visit 3) in gait velocity (cm/s) assessed during the 6 Minutes Walk-Test (6MWT). | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Stance time variability | Change from baseline to Week 12 (Visit 3) in Stance Time Variability assessed during the 6MWT. | Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caroline Moreau, MD, PhD | Contact | 0320446752 | caroline.moreau@chru-lille.fr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 9, 2023 | Aug 3, 2023 |
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| Physiotherapy | Other | Conventional physiotherapy as prescribed by the neurologists |
|
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 27, 2023 | Aug 16, 2023 | ICF_001.pdf |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020233 | Gait Disorders, Neurologic |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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