Psychometric Qualities IPAQ-SF

Amputation Clinical Trial

— QUAPSY  

Official title:

Evaluation of the Psychometric Qualities of the International Physical Activity Questionnaire-Short Form (IPAQ-SF) in Patients With Lower Limb Amputations (QUAPSY)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05989113
• Other study ID #: HOP23-RIPH3-09
• Status: Recruiting
• Start date: May 3, 2023
• Est. completion date: September 2023

Study information

• Verified date: April 2023
• Source: FondationbHopale
• Contact: Marine Deseur
• Phone: 0362882780
• Email: marine.deseur[@]fondation-hopale.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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:

• Once during the consultation,

• Once at home.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Gender: All
• Age group: 15 Years to 69 Years

Eligibility

Inclusion Criteria:

• Patients who have undergone a major lower limb amputation: transtibial, transfemoral, hip or knee disarticulation or trans-iliolumbar

• Fitting more than 1 year old

• Age 15-69 years (IPAQ-SF not validated outside these ages)

• All causes of amputation (vascular, traumatic, tumor, infectious...)

• Patient having given their informed consent

• Patient affiliated to a social security system

Exclusion Criteria:

• Subjects with bilateral amputations

• Inability to fully and adequately understand the questionnaire (i.e., cognitive impairment, patient does not speak French)

• Contraindication to the 6-minute walk test (chest pain, palpitations, mental confusion or lack of coordination and balance, dizziness or malaise, intolerable dyspnea, leg cramps or extreme leg muscle fatigue, any other clinically justified reason).

• Patients under legal protection (under guardianship, under curatorship, safeguard of justice)

• Pregnant or breast-feeding woman

Related Conditions & MeSH terms

• Amputation
• Gait Analysis
• Lower Extremity Amputation

Intervention

Other:
• Administration of the IPAQ-SF questionnaire
Administration of the IPAQ-SF questionnaire at the patient's consultation and upon return home

Locations

Country	Name	City	State
France	Institut Calvé	Berck
France	CHRU Lille - Hôpital Swynghedauw	Lille
France	CRF les HAUTOIS- CRO	Oignies

Sponsors (1)

Lead Sponsor	Collaborator
FondationbHopale

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Relationships between the level of amputation and the IPAQ-SF score.	5 levels of amputation : Hip disarticulation; Transfemoral amputation; Knee disarticulation; Transtibial amputation; Trans-iliolumbar amputation	Data collection during the routine consultation on the day of inclusion
Secondary	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
Secondary	Relationships between type of prosthesis and the IPAQ-SF score.		Data collection during the routine consultation on the day of inclusion
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   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.
•   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.
•   Del Din, S., Galna, B., Godfrey, A., Bekkers, E. M. J., Pelosin, E., Nieuwhof, F., Mirelman, A., Hausdorff, J. M., & Rochester, L. (2019). Analysis of Free-Living Gait in Older Adults With and Without Parkinson's Disease and With and Without a History of
•   Hordacre, B., Barr, C., & Crotty, M. (2014). Use of an activity monitor and GPS device to assess community activity and participation in transtibial amputees. Sensors (Basel, Switzerland), 14(4), 5845-5859
•   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
•   Shema-Shiratzky (2019). Deterioration of specific aspects of gait during the instrumented 6-min walk test among people with multiple sclerosis. Jou
•   Van Schooten (2016). Daily-Life Gait Quality as Predictor of Falls in Older People: A 1-Year Prospective Cohort Study.
•   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.