AmputationQUAPSYNCT05989113
Psychometric Qualities IPAQ-SF
An observational study of Amputation and Lower Extremity Amputation, run by FondationbHopale at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 15 to 69 years
- Conditions the study is for
- Amputation, Lower Extremity Amputation, Gait Analysis
- What is being tested?
- Administration of the IPAQ-SF questionnaire
- How many people
- 100 participants
- Where
- 3 sitesFrance
- Study dates
- 3 May 2023to Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 69 years
- All sexes
- Child, Adult, Older adult
Study population: Lower limb amputee patients with devices
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Elias Ghehioueche contact
France3 sites, 3 recruiting
- Recruiting
Institut Calvé
Berck
Marine Deseur, 03 62 88 27 80
- Recruiting
CHRU Lille - Hôpital Swynghedauw
Lille, 59037
Elias GHEHIOUECHE
- Recruiting
CRF les HAUTOIS- CRO
Oignies, 62590
Elias GHEHIOUECHE
About this study
Official title: Evaluation of the Psychometric Qualities of the International Physical Activity Questionnaire-Short Form (IPAQ-SF) in Patients With Lower Limb Amputations (QUAPSY)
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.
Read the detailed 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.
- Conditions
- Amputation, Lower Extremity Amputation, Gait Analysis, Questionnaires
- Being tested
- Administration of the IPAQ-SF questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of the IPAQ-SF questionnaireOther
Administration of the IPAQ-SF questionnaire at the patient's consultation and upon return home
| Study group | Role | What they receive |
|---|---|---|
| Lower limb amputee patients with devices | Not described Receives: Other: Administration of the IPAQ-SF questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Data collection during the routine consultation on the day of inclusion
Secondary outcomes (9)
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.
Measured: Data collection during the routine consultation on the day of inclusion
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
Measured: 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
Measured: Data collection during the routine consultation on the day of inclusion
Relationships between type of prosthesis and the IPAQ-SF score.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Data collection during the 6-minute routine consultation test on the day of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start3 May 2023
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FondationbHopale
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric Charlaté, Principal investigator, Fondation Hopale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989113
- Sponsor's protocol ID
- HOP23-RIPH3-09
- Acronym
- QUAPSY
- Status last verified
- Apr 2023
- First submitted
- 27 Apr 2023
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Psychometric Qualities of the International Physical Activity Questionnaire-Short Form (IPAQ-SF) in Patients With Lower Limb Amputations (QUAPSY)
- ClinicalTrials.gov ID
- NCT05989113
- Acronym / sponsor ID
- QUAPSY / HOP23-RIPH3-09
- Conditions
- Amputation, Lower Extremity Amputation, Gait Analysis, Questionnaires
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- FondationbHopaleUniversity, hospital or other
- Study start
- 3 May 2023 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lower limb amputee patients with devices | – | Other: Administration of the IPAQ-SF questionnaire |
Who may qualify
- Ages
- 15 to 69 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Lower limb amputee patients with devices
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of the IPAQ-SF questionnaireAdministration of the IPAQ-SF questionnaire at the patient's consultation and upon return home | Other | Lower limb amputee patients with devices |
Primary outcome
Correlation of the METs/week questionnaire results with the results of the 6-minute walk test
Time frame: Data collection during the routine consultation on the day of inclusion
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.
9 secondary outcomes
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.
Time frame: Data collection during the routine consultation on the day of inclusion
Relationships between the level of amputation and the IPAQ-SF score.
Time frame: Data collection during the routine consultation on the day of inclusion
Relationships between the patient's weight and the IPAQ-SF score.
Time frame: Data collection during the routine consultation on the day of inclusion
Relationships between type of prosthesis and the IPAQ-SF score.
Time frame: Data collection during the routine consultation on the day of inclusion
Relationships between the age of amputation and the IPAQ-SF score.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Data collection during the 6-minute routine consultation test on the day of inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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), 985-990Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Shema-Shiratzky (2019). Deterioration of specific aspects of gait during the instrumented 6-min walk test among people with multiple sclerosis. JouLink provided by the sponsor.
- Van Schooten (2016). Daily-Life Gait Quality as Predictor of Falls in Older People: A 1-Year Prospective Cohort Study.Link provided by the sponsor.
Related trials for Amputation
Active, not recruiting
Magnetic Bead Tracking System and eOPRA Implant System With Bionic Prosthesis for Transtibial Amputees
Amputation
Not yet recruitingPhase 4
Role of Perineural Catheter in Pain Control and Opioid Consumption After Major Amputation of Lower Limb
Lower Limb Surgery, Pain
Recruiting
Hemocoll, Avitene, or Bone Wax for Cancellous Bone Bleeding After Single-Ray Amputation
Hemostasis, Surgical Blood Loss
Enrolling by invitation
Early Rehabilitation After Transfemoral Amputation in Moderately Active Patients Using the Avior Knee
Transfemoral Amputees
Recruiting
Bio Leg: Advancing Mobility (BAM)
Amputation of Lower Limb Above Knee, Amputee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elias Ghehioueche contact
Frédéric Charlaté principal investigator
Fondation Hopale
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation and Lower Extremity Amputation, run by FondationbHopale at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marine Deseur (0362882780, marine.deseur@fondation-hopale.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of the METs/week questionnaire results with the results of the 6-minute walk test (time frame: Data collection during the routine consultation on the day of inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.