Unilateral Transfemoral Amputation in Prosthetic UsersLOAD TFNCT07875634
Impact of Anterior Load Carriage on Gait in Individuals With Transfemoral Amputation
A study testing Anterior Load Carriage During Walking in people with Unilateral Transfemoral Amputation in Prosthetic Users, run by Institut Robert Merle d'aubigné at 1 site in France.
Trial summary
This monocentric prospective crossover study aims to evaluate the impact of anterior load carriage on gait performance in individuals with unilateral transfemoral amputation using a prosthesis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unilateral Transfemoral Amputation in Prosthetic Users
- What is being tested?
- Anterior Load Carriage During Walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Unilateral transfemoral amputation.
- Regular use of a lower-limb prosthesis for at least 6 months.
- Functional level K2, K3, or K4.
- Ability to walk independently with the prosthesis, without an assistive device, and complete the study assessments.
- Stable clinical condition at the time of inclusion.
Who cannot join
- Unstable residual-limb pain, socket-related pain, or musculoskeletal pain affecting gait.
- Active skin lesion or wound on the residual limb.
- Neurological, vestibular, or orthopedic disorder significantly affecting gait or balance.
- Unstable cardiovascular, respiratory, or metabolic disease contraindicating walking exercise.
- Known pregnancy.
- Persons deprived of liberty by judicial or administrative decision.
- Persons under legal protection incompatible with participation in the research.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Institut Merle d'Aubigné
Valenton, Île-de-France Region, 94460
Anton KANIEWSKI, 01 45 10 80 97, a.kaniewski@irma-valenton.fr
Anton KANIEWSKI
About this study
Official title: Impact of Anterior Load Carriage on Gait in Individuals With Transfemoral Amputation Using a Prosthesis: A Monocentric Cross-Over Study
This monocentric prospective crossover study aims to evaluate the impact of anterior load carriage on gait performance in individuals with unilateral transfemoral amputation using a prosthesis. Participants will complete three randomized walking conditions during a single assessment session: no load, a light anterior load corresponding to 7.5% of body weight simulating child carrying, and a heavier anterior load corresponding to 15% of body weight simulating a utility load. Gait performance, biomechanical adaptations, physiological cost of walking, perceived exertion, and prosthetic comfort will be assessed using instrumented gait analysis and standardized clinical measures. The study seeks to improve understanding of how daily load-carrying tasks affect mobility and balance in prosthetic users and to provide evidence for rehabilitation strategies and prosthetic management.
- Being tested
- Anterior Load Carriage During Walking
- Keywords
- Transfemoral Amputation, Prosthesis, Anterior Load Carriage, Biomechanics, Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior Load Carriage During WalkingBehavioural
Participants perform walking trials with an anterior load corresponding to either 7.5% or 15% of body weight. The conditions are designed to simulate common daily activities such as carrying a young child or transporting a utility load.
| Study group | Role | What they receive |
|---|---|---|
| No Load | No intervention | Walking trials performed without an anterior load. This is the control condition. |
| Light Anterior Load | Experimental | Walking trials performed while carrying an anterior load corresponding to 7.5% of body weight, intended to simulate carrying a young child. Receives: Behavioral: Anterior Load Carriage During Walking |
| Heavy Anterior Load | Experimental | Walking trials performed while carrying an anterior load corresponding to 15% of body weight, intended to simulate carrying a utility load. Receives: Behavioral: Anterior Load Carriage During Walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-selected walking speed (m/s)
Change in self-selected walking speed measured during instrumented gait analysis across the three experimental conditions: no load, light anterior load, and heavy anterior load.
Measured: During the single study visit (Day 0), under each experimental condition
Secondary outcomes (13)
Physiological Cost Index (PCI)
Physiological cost of walking assessed using the Physiological Cost Index.
Measured: During the single study visit (Day 0), under each experimental condition
Perceived exertion
Perceived exertion assessed using the Borg scale.
Measured: During the single study visit (Day 0), under each experimental condition
Socket Comfort Score (SCS)
Prosthetic socket comfort assessed using the Socket Comfort Score.
Measured: During the single study visit (Day 0), under each experimental condition
Cadence
Cadence measured during instrumented gait analysis, expressed in steps per minute (steps/min), under each experimental condition.
Measured: During the single study visit (Day 0), under each experimental condition.
Step length
Step length measured during instrumented gait analysis, expressed in meters (m), under each experimental condition.
Measured: During the single study visit (Day 0), under each experimental condition.
Single support time
Duration of the single support phase measured during instrumented gait analysis, expressed as a percentage of the gait cycle (%), under each experimental condition.
Measured: During the single study visit (Day 0), under each experimental condition.
Double support time
Duration of the double support phase measured during instrumented gait analysis, expressed as a percentage of the gait cycle (%), under each experimental condition.
Measured: During the single study visit (Day 0), under each experimental condition.
Step width
Step width measured during instrumented gait analysis, expressed in centimeters (cm), under each experimental condition.
Measured: During the single study visit (Day 0), under each experimental condition.
Gait symmetry index
Gait symmetry index calculated from spatiotemporal gait parameters to quantify asymmetry between the prosthetic and intact limbs under each experimental condition.
Measured: During the single study visit (Day 0), under each experimental condition.
Trunk inclination angle
Anterior trunk inclination angle measured during instrumented gait analysis, expressed in degrees (°), under each experimental condition.
Measured: During the single study visit (Day 0), under each experimental condition.
Pelvic range of motion in the sagittal plane
Pelvic angular range of motion in the sagittal plane measured during instrumented gait analysis, expressed in degrees (°).
Measured: During the single study visit (Day 0), under each experimental condition.
Pelvic range of motion in the frontal plane
Pelvic angular range of motion in the frontal plane measured during instrumented gait analysis, expressed in degrees (°).
Measured: During the single study visit (Day 0), under each experimental condition.
Pelvic range of motion in the transverse plane
Pelvic angular range of motion in the transverse plane measured during instrumented gait analysis, expressed in degrees (°).
Measured: During the single study visit (Day 0), under each experimental condition.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Transfemoral Amputation in Prosthetic UsersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant serves as their own control and completes all three walking conditions during a single study visit. The order of the three conditions is randomized to reduce order, learning, and fatigue effects.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Robert Merle d'aubigné
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anton KANIEWSKI, Principal investigator, Institut Merle d'Aubigné
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875634
- Sponsor's protocol ID
- 2026-RIPH2-001
- Other IDs
- 2026-A01366-45
- Acronym
- LOAD TF
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 15 Oct 2026
- 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 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Anterior Load Carriage on Gait in Individuals With Transfemoral Amputation Using a Prosthesis: A Monocentric Cross-Over Study
- ClinicalTrials.gov ID
- NCT07875634
- Acronym / sponsor ID
- LOAD TF / 2026-RIPH2-001
- Keywords
- Transfemoral Amputation, Prosthesis, Anterior Load Carriage, Biomechanics, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Institut Robert Merle d'aubignéUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 15 Oct 2026 (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 monocentric prospective crossover study aims to evaluate the impact of anterior load carriage on gait performance in individuals with unilateral transfemoral amputation using a prosthesis. Participants will complete three randomized walking conditions during a single assessment session: no load, a light anterior load corresponding to 7.5% of body weight simulating child carrying, and a heavier anterior load corresponding to 15% of body weight simulating a utility load. Gait performance, biomechanical adaptations, physiological cost of walking, perceived exertion, and prosthetic comfort will be assessed using instrumented gait analysis and standardized clinical measures. The study seeks to improve understanding of how daily load-carrying tasks affect mobility and balance in prosthetic users and to provide evidence for rehabilitation strategies and prosthetic management.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Each participant serves as their own control and completes all three walking conditions during a single study visit. The order of the three conditions is randomized to reduce order, learning, and fatigue effects.
| Arm | Type | Receives |
|---|---|---|
| No Load | No intervention | –Walking trials performed without an anterior load. This is the control condition. |
| Light Anterior Load | Experimental | Behavioral: Anterior Load Carriage During WalkingWalking trials performed while carrying an anterior load corresponding to 7.5% of body weight, intended to simulate carrying a young child. |
| Heavy Anterior Load | Experimental | Behavioral: Anterior Load Carriage During WalkingWalking trials performed while carrying an anterior load corresponding to 15% of body weight, intended to simulate carrying a utility load. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18 years or older.
- Unilateral transfemoral amputation.
- Regular use of a lower-limb prosthesis for at least 6 months.
- Functional level K2, K3, or K4.
- Ability to walk independently with the prosthesis, without an assistive device, and complete the study assessments.
Key exclusion criteria (7 listed)
- Unstable residual-limb pain, socket-related pain, or musculoskeletal pain affecting gait.
- Active skin lesion or wound on the residual limb.
- Neurological, vestibular, or orthopedic disorder significantly affecting gait or balance.
- Unstable cardiovascular, respiratory, or metabolic disease contraindicating walking exercise.
- Known pregnancy.
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 |
|---|---|---|
| Anterior Load Carriage During WalkingParticipants perform walking trials with an anterior load corresponding to either 7.5% or 15% of body weight. The conditions are designed to simulate common daily activities such as carrying a young child or transporting a utility load. | Behavioural | Heavy Anterior Load, Light Anterior Load |
Primary outcome
Self-selected walking speed (m/s)
Time frame: During the single study visit (Day 0), under each experimental condition
Change in self-selected walking speed measured during instrumented gait analysis across the three experimental conditions: no load, light anterior load, and heavy anterior load.
13 secondary outcomes
Physiological Cost Index (PCI)
Time frame: During the single study visit (Day 0), under each experimental condition
Perceived exertion
Time frame: During the single study visit (Day 0), under each experimental condition
Socket Comfort Score (SCS)
Time frame: During the single study visit (Day 0), under each experimental condition
Cadence
Time frame: During the single study visit (Day 0), under each experimental condition.
Step length
Time frame: During the single study visit (Day 0), under each experimental condition.
Single support time
Time frame: During the single study visit (Day 0), under each experimental condition.
Double support time
Time frame: During the single study visit (Day 0), under each experimental condition.
Step width
Time frame: During the single study visit (Day 0), under each experimental condition.
Gait symmetry index
Time frame: During the single study visit (Day 0), under each experimental condition.
Trunk inclination angle
Time frame: During the single study visit (Day 0), under each experimental condition.
Pelvic range of motion in the sagittal plane
Time frame: During the single study visit (Day 0), under each experimental condition.
Pelvic range of motion in the frontal plane
Time frame: During the single study visit (Day 0), under each experimental condition.
Pelvic range of motion in the transverse plane
Time frame: During the single study visit (Day 0), under each experimental condition.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
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.
Anton KANIEWSKI principal investigator
Institut Merle d'Aubigné
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior Load Carriage During Walking in people with Unilateral Transfemoral Amputation in Prosthetic Users, run by Institut Robert Merle d'aubigné 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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 15 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anton KANIEWSKI (01 45 10 80 97, a.kaniewski@irma-valenton.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-selected walking speed (m/s) (time frame: During the single study visit (Day 0), under each experimental condition). 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 15 Oct 2026.