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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-A00678-35 | Other Identifier | ID RCB |
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personnel involved in clinical trial will not be available to conduct the research
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| Name | Class |
|---|---|
| University Grenoble Alps | OTHER |
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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The aim of this randomized controlled pilot trial is to assess the impact of different gait rehabilitation programs on the level of physical activity and gait in daily life in patients with Parkinson's disease (PD).
Two groups of 25 patients with PD will benefit from one of two gait training programs (treadmill vs. nordic walking), 3 times a week for 12 weeks. Activity level and number of steps will be remotely recorded over 7 days before, at the end, 3 and 6 months after the end of the program. Quality of life will be recorded at each time point.
The impact of the gait programs on the patients' level of daily activity will be examined, comparing the changes brought about by the two programs, taking into account the modulating influence of age and cognitive function.
Gait under conditions of daily life will be compared to gait parameters collected in the laboratory.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treadmill walking | Experimental | The training program will last 12 weeks and consist of treadmill walking. The duration of the walking bouts (and pauses), and the speed of the belt will be adjusted as needed following the patients' progress. Music will be added as suited to boost motivation and support regular cadence. All training sessions will be supervised. |
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| Nordic walking | Experimental | The training program will last 12 weeks and consist of Nordic walking, taught and supervised by an adapted physical activity teacher. The session will be carried out outside, weather permitting. When possible, training will gather 2 to 4 patients for group emulation. The duration of the walking bouts (and pauses) will be adjusted to follow the patients' progress. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical training | Behavioral | Supervised gait training program 3 times a week, 12 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in daily energy expenditure | Evolution over time of the daily energy expenditure together with number of steps, as recorded using an actimeter worn at the belt. | recording 7 days in a row, at 3 months, 6 months and 9 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of gait parameters | Evolution over time of spatio-temporal gait parameters recorded during a gait test in the laboratory. | 3 months, 6 months and 9 months. |
| Evolution of exercise functional capacity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Moro Elena, MD PhD | Grenoble Alpes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Grenoble Alpes | Grenoble | 38043 | France |
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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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| ID | Term |
|---|---|
| D064797 | Physical Conditioning, Human |
| ID | Term |
|---|---|
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
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The researchers involved in data collection and in data analysis will be blinded with regard to the patients' group allocation. Randomization will be performed by an operator not otherwise involved in the study, under the RED-Cap application.
Evolution over time of the patients' performance at the 6 minutes walk test
| 3 months, 6 months and 9 months. |
| Evolution over time of the Parkinson's Disease Questionnaire-39 scale score. | Evolution of quality of life as measured using the PDQ.39 scale. Summed item scores expressed as percent. Min 0 Max 100. | 3 months, 6 months and 9 months. |
| Evolution over time of the Parkinsons' Disease Fatigue Scale score. | Evolution of fatigue as measured using the PD Fatigue scale. Min 0. Max 80. Greater score means greater fatigue | 3 months, 6 months and 9 months. |
| Adherence to the training program | number of training sessions attended | 3 months |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D055687 |
| Musculoskeletal and Neural Physiological Phenomena |