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This is an observational, prospective multicentric study designed to develop medical knowledge.
The aim of the study is to validate the IPAQ-SF questionnaire in a population of lower limb amputee patients.
The questionnaire is administered twice to each patient, once during the consultation and again when they return home. Patients also undergo a 6-minute walk test.
This is an observational, prospective multicentric study designed to develop medical knowledge.
The IPAQ is an internationally validated questionnaire for measuring physical activity in healthy subjects.
The IPAQ-SF (short format of the IPAQ) assesses overall physical activity and sedentary time during the last seven days. The IPAQ-SF has been used in a population of lower limb amputees on several occasions, but no study of its psychometric qualities in application to this population has been performed to date.
The main objective of the study is therefore to gather a set of arguments allowing the IPAQ-SF to be used in the follow-up consultation of patients with lower limb amputations who are fitted with a device.
This would help health professionals to assess the physical activity of this population and to develop physical activity promotion interventions adapted to their needs.
This study is part of the standard management of patients with lower limb amputations and devices. In addition to the clinical data and the result of the 6-minute test from the classical management, the IPAQ-SF questionnaire will be completed twice by the patients included in this study:
For the only center equipped (center 01) with inertial sensors, the gait parameters during the 6-minute test will be collected in order to extract fatigue indices.
Upon completion of the IPAQ-SF questionnaire a second time, the patient's participation in the study ends.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lower limb amputee patients with devices |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Administration of the IPAQ-SF questionnaire | Other | Administration of the IPAQ-SF questionnaire at the patient's consultation and upon return home |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of the METs/week questionnaire results with the results of the 6-minute walk test | The results of the IPAQ-SF questionnaire will be expressed in METs/week (Metabolic Equivalent of Task). The distance covered by the patient at the end of the 6-minute test will be collected in meters. | Data collection during the routine consultation on the day of inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Relationships between the patients ability to perform his or her expected daily functions after rehabilitation (MFCL classification, out of 5 points) and the IPAQ-SF score. | The MFCL consists of five ordered categories or 'K-levels' that define increasing functional mobility. | Data collection during the routine consultation on the day of inclusion |
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Inclusion Criteria:
Exclusion Criteria:
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Lower limb amputee patients with devices
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marine Deseur | Contact | 0362882780 | marine.deseur@fondation-hopale.org | |
| Elias Ghehioueche | Contact | elias.ghehioueche@chu-lille.fr |
| Name | Affiliation | Role |
|---|---|---|
| Frédéric Charlaté | Fondation Hopale | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Calvé | Recruiting | Berck | France |
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| Label | URL |
|---|---|
| Deans S, Burns D, McGarry A, et al. Motivations and barriers to prosthesis users participation in physical activity, exercise and sport: a review of the literature. Prosthet Orthot Int. 2012;36:260-269. | View source |
| Wetterhahn, K. A., Hanson, C., \& Levy, C. E. (2002). Effect of participation in physical activity on body image of amputees. American journal of physical medicine \& rehabilitation, 81(3), 194-201. | View source |
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| Relationships between the level of amputation and the IPAQ-SF score. | 5 levels of amputation :
| Data collection during the routine consultation on the day of inclusion |
| Relationships between the patient's weight and the IPAQ-SF score. | Patient's weight in kilogram | Data collection during the routine consultation on the day of inclusion |
| Relationships between type of prosthesis and the IPAQ-SF score. | Data collection during the routine consultation on the day of inclusion |
| Relationships between the age of amputation and the IPAQ-SF score. | Age of amputation in years | Data collection during the routine consultation on the day of inclusion |
| Relationships between the physical activity level of lower limb amputee patients and the patient's walking speed measured by inertial units during the 6-minute test. | The 6-min walk test (TM6) measures the greatest distance covered in 6 min of walking around two studs separated by 30 meters. Patient's walking speed in meters per second during the 6-minute test. | Data collection during the 6-minute routine consultation test on the day of inclusion |
| Relationship between the physical activity level of patients with lower-limb amputations and the patient's average step length measured by inertial units during the 6-minute test. | The 6-min walk test (TM6) measures the greatest distance covered in 6 min of walking around two studs separated by 30 meters. Patient's average step length in centimeters during the 6-minute test. | Data collection during the 6-minute routine consultation test on the day of inclusion |
| Relationship between the physical activity level of patients with lower-limb amputations and the average width of the patient's step measured by inertial units during the 6-minute test. | The 6-min walk test (TM6) measures the greatest distance covered in 6 min of walking around two studs separated by 30 meters. Patient's average step width in centimeters during the 6-minute test. | Data collection during the 6-minute routine consultation test on the day of inclusion |
| Relationship between the physical activity level of patients with lower-limb amputations and the patient's walking cadence measured by inertial units during the 6-minute test. | The 6-min walk test (TM6) measures the greatest distance covered in 6 min of walking around two studs separated by 30 meters. Number of steps per minute during the 6-minute test. | Data collection during the 6-minute routine consultation test on the day of inclusion |
| CHRU Lille - Hôpital Swynghedauw | Recruiting | Lille | 59037 | France |
|
| CRF les HAUTOIS- CRO | Recruiting | Oignies | 62590 | France |
|
| Melo, V. H., Sousa, R. A. L., Improta-Caria, A. C., \& Nunes, M. A. P. (2021). Physical activity and quality of life in adults and elderly individuals with lower limb amputation. Revista da Associacao Medica Brasileira (1992), 67(7), 985-990 | View source |
| da Silva, R., Rizzo, J. G., Gutierres Filho, P. J., Ramos, V., \& Deans, S. (2011). Physical activity and quality of life of amputees in southern Brazil. Prosthetics and orthotics international, 35(4), 432-438. | View source |
| Shema-Shiratzky (2019). Deterioration of specific aspects of gait during the instrumented 6-min walk test among people with multiple sclerosis. Jou | View source |
| Van Schooten (2016). Daily-Life Gait Quality as Predictor of Falls in Older People: A 1-Year Prospective Cohort Study. | View source |