Lower Limb AmputationSTRAALNCT05420623
Walking Strategies in Usual Locomotion of Lower Limb Amputees
An observational study of Lower Limb Amputation, run by FondationbHopale at 1 site in France.
Trial summary
Amputation is a life-altering event with an immediate and obvious effect on daily life activities and quality of life. Asymmetrical movements of the lower limbs and compensatory strategies during walking are associated with an elevated risk for developing deleterious secondary health conditions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lower Limb Amputation
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 16 Dec 2021to 16 Dec 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Visits are carried out as part of routine care, either in the case of a follow-up consultation, or as part of a scheduled entry into a rehabilitation center. If the patient is included at the entrance of a scheduled rehabilitation stay, the data from his last follow-up consultation will be recovered retrospectively (follow-up AQM + functional tests). Recruitment of healthy volunteers : The study will be offered to the companions of people followed in rehabilitation at the Jacques Calvé center. Posters will be placed at the reception desk of the institution and in the consultation waiting rooms.
Who may be able to join
- Major amputation of the lower limb,
- Unilateral amputation,
- Aged 18 or over,
- Mobility level equal to or greater than 2 (according to Medicare Functional Classification Levels),
- Subject who has given his or her free and informed consent.
- Non-inclusion Criteria (Amputees patients):
Show all 20Show fewer
- Definitive apparatus less than one month old,
- Contraindications for walking,
- Presence of a major neurocognitive disorder reported in the medical record (as mentioned in the DMS-5): acquired, significant and progressive reduction in abilities in one or more cognitive domains, significant enough to no longer be able to perform activities of daily living alone (loss of autonomy)
- Cognitive disorders reported in the medical file,
- Subject under guardianship, curatorship or protective measure,
- Pregnant or lactating woman.
- Able to walk 50m alone.
- Non- Inclusion Criteria (Healthy volunteers):
- Contraindication to effort,
- Cognitive disorders known by the subject, causing difficulties in performing tasks related to activities of daily living
- Any history of neurological or orthopedic origin likely to limit the quality of walking,
- Notion of trauma on the musculoskeletal system less than 3 months (sprain type, muscle injury, etc.),
- Subject under guardianship, curatorship or protective measure,
- Pregnant or lactating woman.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site
Fondation HOPALE - Centre de rééducation Jacques CALVE
Berck, Hauts-de-France, 62608
About this study
Official title: Determination and Evolution of Usual Locomotion Strategies of Lower Limb Amputees by Gait Analysis
Amputation is a life-altering event with an immediate and obvious effect on daily life activities and quality of life. Asymmetrical movements of the lower limbs and compensatory strategies during walking are associated with an elevated risk for developing deleterious secondary health conditions. It is well established that therapeutic gait training methods are effective in reducing spatiotemporal gait deviations and improving functional mobility. However, the littérature does not clearly indicate the best time to perform a gait training or which gait parameters predict it.
The main aim of this study is to determinate the walking strategies of lower limb amputees in several locomotion tasks on daily life. Then, the investigators study the evolution of these walking strategies after a gait training and over time.
Read the detailed description
Quantified gait analyses are included in the practice for consultations to monitor orthopaedic devices, and are specific to the study for the rehabilitation stay (V2 and V3).
The subjects in the control group will be recruited from among the carers of patients undergoing rehabilitation and from among volunteers recruited by means of posters in the establishments of the HOPALE Foundation in Berck.
Once the eligibility criteria have been checked, a quantified gait analysis and functional tests will be carried out: the 6-minute walk test (T6M) and the Time Up and Go test (TUG). They will complete a single visit lasting approximately 1 hour and 30 minutes.
- Conditions
- Lower Limb Amputation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Amputees patients | Not described | |
| control group: non-amputees | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data from the quantified gait assessment: walking speed (m/s)
Full body motion capture was systematically analyzed for different walking conditions
- normal and fast walking on self selected walking speed, walking on cross-slope, go up and down a step, and turn.
Measured: Inclusion
Data from the quantified gait assessment: step length (m)
Full body motion capture was systematically analyzed for different walking conditions
- normal and fast walking on self selected walking speed, walking on cross-slope, go up and down a step, and turn.
Measured: Inclusion
Data from the quantified gait assessment: step time (s)
Full body motion capture was systematically analyzed for different walking conditions
- normal and fast walking on self selected walking speed, walking on cross-slope, go up and down a step, and turn.
Measured: Inclusion
Data from the quantified gait assessment: lower limbs joint angles (degrees)
Full body motion capture was systematically analyzed for different walking conditions
- normal and fast walking on self selected walking speed, walking on cross-slope, go up and down a step, and turn.
Measured: Inclusion
Data from the quantified gait assessment: joint moments (N.m/kg)
Full body motion capture was systematically analyzed for different walking conditions
- normal and fast walking on self selected walking speed, walking on cross-slope, go up and down a step, and turn.
Measured: Inclusion
Data from the quantified gait assessment: trunk and pelvis position (degrees)
Full body motion capture was systematically analyzed for different walking conditions
- normal and fast walking on self selected walking speed, walking on cross-slope, go up and down a step, and turn.
Measured: Inclusion
Data from the quantified gait assessment: ground reaction forces (N).
Full body motion capture was systematically analyzed for different walking conditions
- normal and fast walking on self selected walking speed, walking on cross-slope, go up and down a step, and turn.
Measured: Inclusion
Secondary outcomes (11)
The correlations between some data from clinical assessment and gait parameters are analyzed : pain scale (Numerical Rating Scale)
Measured: Inclusion
The correlations between some data from clinical assessment and gait parameters are analyzed : strenght testing of hip abductor/extensor/flexor and knee extensor/flexor (if applicable)
This measurement will be collected with handheld dynamometer (Newton)
Measured: Inclusion
The correlations between some data from clinical assessment and gait parameters are analyzed : amputation level and etiology, prosthesis characteristics, lower limbs range of motion with manual goniometer (degrees)
Measured: Inclusion
The correlations between some data from clinical assessment and gait parameters are analyzed : amputation level and etiology, prosthesis characteristics, functional walking tests (timed up and go test - in seconds).
Measured: Inclusion
The correlations between some data from clinical assessment and gait parameters are analyzed : amputation level and etiology, prosthesis characteristics, functional walking tests (six minute walk test - in meters).
Measured: Inclusion
These clinical assessment and these gait parameters on the conditions mentioned are analyzed before and after rehabilitation during consultations, and then at 6 months and at 12 months : pain scale (Numerical Rating Scale)
Measured: Inclusion, 6 months, 12 months
These clinical assessment and these gait parameters on the conditions mentioned are analyzed before and after rehabilitation, and at 6 and 12 months: strenght testing of hip abductor/extensor/flexor and knee extensor/flexor (if applicable)
This measurement will be collected with handheld dynamometer (Newton)
Measured: Inclusion, 6 months, 12 months
These clinical assessment and these gait parameters on the conditions mentioned are analyzed before and after rehabilitation during consultations, and then at 6 months and at 12 months : lower limbs range of motion with manual goniometer (degrees)
Measured: Inclusion, 6 months, 12 months
These clinical assessment and these gait parameters on the conditions mentioned are analyzed before and after rehabilitation during consultations, and then at 6 months and at 12 months : functional walking tests (timed up and go test, in seconds)
Measured: Inclusion, 6 months, 12 months
The correlations between some data from clinical assessment and gait parameters are analyzed : amputation level and etiology, prosthesis characteristics, functional walking tests (six-minute walk test, in meters).
Measured: Inclusion, 6 months, 12 months
If you need a walking aid, the investigators compares the force applied to the walking aid, using a force sensor (Newton), with biomechanical compensations.
Measured: Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start16 Dec 2021
- Primary completion16 Dec 2023
- Study completion16 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb 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-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- FondationbHopale
- Sponsor type
- University, hospital or other
- Collaborators
- Lille Catholic University
- Responsible party
- Sponsor
- Investigators
- Frederic CHARLATE, Principal investigator, Fondation Hopale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420623
- Sponsor's protocol ID
- HOP-RIPH2-21-01
- Acronym
- STRAAL
- Status last verified
- Aug 2023
- First submitted
- 13 Dec 2021
- Last updated
- 7 Jan 2025
- 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 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination and Evolution of Usual Locomotion Strategies of Lower Limb Amputees by Gait Analysis
- ClinicalTrials.gov ID
- NCT05420623
- Acronym / sponsor ID
- STRAAL / HOP-RIPH2-21-01
- Conditions
- Lower Limb Amputation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- FondationbHopaleUniversity, hospital or other
- Collaborators
- Lille Catholic University
- Study start
- 16 Dec 2021 (actual)
- Primary completion
- 16 Dec 2023 (actual)
- Study completion
- 16 Dec 2023 (actual)
- First posted
- 15 Jun 2022 (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.
Amputation is a life-altering event with an immediate and obvious effect on daily life activities and quality of life. Asymmetrical movements of the lower limbs and compensatory strategies during walking are associated with an elevated risk for developing deleterious secondary health conditions. It is well established that therapeutic gait training methods are effective in reducing spatiotemporal gait deviations and improving functional mobility. However, the littérature does not clearly indicate the best time to perform a gait training or which gait parameters predict it.
The main aim of this study is to determinate the walking strategies of lower limb amputees in several locomotion tasks on daily life. Then, the investigators study the evolution of these walking strategies after a gait training and over time.
Detailed description
Quantified gait analyses are included in the practice for consultations to monitor orthopaedic devices, and are specific to the study for the rehabilitation stay (V2 and V3).
The subjects in the control group will be recruited from among the carers of patients undergoing rehabilitation and from among volunteers recruited by means of posters in the establishments of the HOPALE Foundation in Berck.
Once the eligibility criteria have been checked, a quantified gait analysis and functional tests will be carried out: the 6-minute walk test (T6M) and the Time Up and Go test (TUG). They will complete a single visit lasting approximately 1 hour and 30 minutes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amputees patients | – | – |
| control group: non-amputees | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Visits are carried out as part of routine care, either in the case of a follow-up consultation, or as part of a scheduled entry into a rehabilitation center. If the patient is included at the entrance of a scheduled rehabilitation stay, the data from his last follow-up consultation will be recovered retrospectively (follow-up AQM + functional tests). Recruitment of healthy volunteers : The study will be offered to the companions of people followed in rehabilitation at the Jacques Calvé center. Posters will be placed at the reception desk of the institution and in the consultation waiting rooms.
Key inclusion criteria (20 listed)
- Major amputation of the lower limb,
- Unilateral amputation,
- Aged 18 or over,
- Mobility level equal to or greater than 2 (according to Medicare Functional Classification Levels),
- Subject who has given his or her free and informed consent.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Data from the quantified gait assessment: walking speed (m/s)
Time frame: Inclusion
Full body motion capture was systematically analyzed for different walking conditions * normal and fast walking on self selected walking speed, walking on cross-slope, go up and down a step, and turn.
Data from the quantified gait assessment: step length (m)
Time frame: Inclusion
Full body motion capture was systematically analyzed for different walking conditions * normal and fast walking on self selected walking speed, walking on cross-slope, go up and down a step, and turn.
Data from the quantified gait assessment: step time (s)
Time frame: Inclusion
Full body motion capture was systematically analyzed for different walking conditions * normal and fast walking on self selected walking speed, walking on cross-slope, go up and down a step, and turn.
Data from the quantified gait assessment: lower limbs joint angles (degrees)
Time frame: Inclusion
Full body motion capture was systematically analyzed for different walking conditions * normal and fast walking on self selected walking speed, walking on cross-slope, go up and down a step, and turn.
Data from the quantified gait assessment: joint moments (N.m/kg)
Time frame: Inclusion
Full body motion capture was systematically analyzed for different walking conditions * normal and fast walking on self selected walking speed, walking on cross-slope, go up and down a step, and turn.
Data from the quantified gait assessment: trunk and pelvis position (degrees)
Time frame: Inclusion
Full body motion capture was systematically analyzed for different walking conditions * normal and fast walking on self selected walking speed, walking on cross-slope, go up and down a step, and turn.
Data from the quantified gait assessment: ground reaction forces (N).
Time frame: Inclusion
Full body motion capture was systematically analyzed for different walking conditions * normal and fast walking on self selected walking speed, walking on cross-slope, go up and down a step, and turn.
11 secondary outcomes
The correlations between some data from clinical assessment and gait parameters are analyzed : pain scale (Numerical Rating Scale)
Time frame: Inclusion
The correlations between some data from clinical assessment and gait parameters are analyzed : strenght testing of hip abductor/extensor/flexor and knee extensor/flexor (if applicable)
Time frame: Inclusion
The correlations between some data from clinical assessment and gait parameters are analyzed : amputation level and etiology, prosthesis characteristics, lower limbs range of motion with manual goniometer (degrees)
Time frame: Inclusion
The correlations between some data from clinical assessment and gait parameters are analyzed : amputation level and etiology, prosthesis characteristics, functional walking tests (timed up and go test - in seconds).
Time frame: Inclusion
The correlations between some data from clinical assessment and gait parameters are analyzed : amputation level and etiology, prosthesis characteristics, functional walking tests (six minute walk test - in meters).
Time frame: Inclusion
These clinical assessment and these gait parameters on the conditions mentioned are analyzed before and after rehabilitation during consultations, and then at 6 months and at 12 months : pain scale (Numerical Rating Scale)
Time frame: Inclusion, 6 months, 12 months
These clinical assessment and these gait parameters on the conditions mentioned are analyzed before and after rehabilitation, and at 6 and 12 months: strenght testing of hip abductor/extensor/flexor and knee extensor/flexor (if applicable)
Time frame: Inclusion, 6 months, 12 months
These clinical assessment and these gait parameters on the conditions mentioned are analyzed before and after rehabilitation during consultations, and then at 6 months and at 12 months : lower limbs range of motion with manual goniometer (degrees)
Time frame: Inclusion, 6 months, 12 months
These clinical assessment and these gait parameters on the conditions mentioned are analyzed before and after rehabilitation during consultations, and then at 6 months and at 12 months : functional walking tests (timed up and go test, in seconds)
Time frame: Inclusion, 6 months, 12 months
The correlations between some data from clinical assessment and gait parameters are analyzed : amputation level and etiology, prosthesis characteristics, functional walking tests (six-minute walk test, in meters).
Time frame: Inclusion, 6 months, 12 months
If you need a walking aid, the investigators compares the force applied to the walking aid, using a force sensor (Newton), with biomechanical compensations.
Time frame: Inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
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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.
Frederic CHARLATE principal investigator
Fondation Hopale
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Limb Amputation, run by FondationbHopale at 1 site 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 20 inclusion and 0 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: finished, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data from the quantified gait assessment: walking speed (m/s) (time frame: Inclusion). The study lists 7 primary outcomes in all. 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 7 Jan 2025.