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The goal of this study is to develop and validate a haptic assistive method in order to support walking in patients with Parkinson's disease, delivered to the patient's hips through a wearable robotic pelvis orthosis.
None of the existing robotic devices used for gait rehabilitation in Parkinson's disease is wearable. Thanks to the wearable robotic pelvis orthosis we will use, the rehabilitation sessions can take place in an ecological environment.
The other advantage of the proposed assistance protocol is its adaptability: patients will feel their hips pattern to be "smoothed" by the robot, but they will keep the freedom of continuously steering their main movement variables (like stride frequency, duration, and length). A key measured metric will precisely rely on this variability between stride durations. Indeed, the degree of stride-to-stride variability was shown to reflect the patient's physiological state, and to be correlated with the stage of the disease.
Experimental trials will be conducted to assess both the assistive (i.e. the therapy effect during the therapy itself) and rehabilitative (i.e. effect after the therapy) natures of our protocol. The second main objective of this project will be the analysis of the effects of our protocol regarding the stride-to-stride variability of patients with Parkinson's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evaluation sessions | Active Comparator | Patients will be evaluated while walking without wearing the robotic device, once before the intervention phase, once right after, and once a month after. |
|
| Intervention phase | Experimental | Patients will walk with the robotic device, for 12 sessions of 10 min. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Pelvis Orthosis | Device | Walking with the robotic device providing the assistive protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Long-Range Autocorrelation (LRA) | Assesses the variability between stride durations | From day 0 up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Unified Parkinson's disease rating scales (UPDRS) | Assesses the disease stage and severity | From day 0 up to 8 weeks |
| Activities-Specific Balance Confidence Scale (ABC) | Self reported measure of balance confidence in performing various activities |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques universitaires Saint-Luc | Brussels | 1200 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37974229 | Derived | Otlet V, Vandamme C, Warlop T, Crevecoeur F, Ronsse R. Effects of overground gait training assisted by a wearable exoskeleton in patients with Parkinson's disease. J Neuroeng Rehabil. 2023 Nov 16;20(1):156. doi: 10.1186/s12984-023-01280-y. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Walking exercises | Other | Walking exercises without wearing the robotic device. |
|
| From day 0 up to 8 weeks |
| Balance Evaluation Systems Test (BESTest) | The balance of subjects is tested during 6 postural control contexts | From day 0 up to 8 weeks |
| Gait analysis | Average stride length and duration, gait symmetry, hips range of motion | From day 0 up to 8 weeks |
| Joint torques | In order to assess the mechanical efforts associated to walking | From day 0 up to 8 weeks |
| Physiological Cost Index | In order to assess the metabolic efforts associated to walking | From day 0 up to 8 weeks |
| System Usability Scale (SUS) | Self reported measure of the fatigue and stress felt by patients | After 4 weeks |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |