Lower Limb TraumaNCT05225792
Rapid Rehabilitation to Treat Lower Extremity Trauma
A study testing Promis Physical Function Questionnaire, L Test and Narrowing Beam Walking Test in people with Lower Limb Trauma, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to find out if an advance balance perturbation training program can enhance the rehabilitation process by increasing weight-bearing strategies on the prosthetic or injured limb, and, help reduce stumbles and falls. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Limb Trauma
- What is being tested?
- Promis Physical Function Questionnaire, L Test and Narrowing Beam Walking Test
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2024to 30 Sep 2027
- 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
- Research participants will be eligible active duty service members and retired veterans.
- Having lower limb trauma (transtibial and transfemoral amputations, bilateral amputations, and limb salvage).
- Are enrolled in conventional rehabilitation at the participating military treatment centers.
- Subjects with dysvascular disease will be excluded because compromised lower limb somatosensation and circulation are independently linked with poor postural stability and a history of frequent falls.
- For subjects with amputations, the individual must be a community ambulator (i.e., K-Level 3 or 4).
- For subjects with limb salvage, they will need to have an IDEO and be entered into the Return-to-Run training program.
Who cannot join
- Subjects must not have excessive pain or other neuromuscular problems that preclude them from performing the test protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Christine Deml, 507-266-0984, deml.christine@mayo.edu
About this study
Official title: Improved Training Method for Advanced Rehabilitation of Warfighters With Lower Extremity Trauma
The purpose of this study is to find out if an advance balance perturbation training program can enhance the rehabilitation process by increasing weight-bearing strategies on the prosthetic or injured limb, and, help reduce stumbles and falls.
- Conditions
- Lower Limb Trauma
- Being tested
- Promis Physical Function Questionnaire, L Test, Narrowing Beam Walking Test, PEQ-A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promis Physical Function QuestionnaireBehavioural
Patient reported physical function outcomes
L TestBehavioural
Performance based measure assessing general physical function and balance ability.
Narrowing Beam Walking TestBehavioural
Subjects attempt to walk along 4 progressively narrower beam segments with their arms crossed over their chest.
PEQ-ABehavioural
Also called Prosthesis Evaluation Questionnaire - Addendum
Survey on confidence, stumbles and falls.
| Study group | Role | What they receive |
|---|---|---|
| Injured Service Members | Experimental | Not described Receives: Behavioral: Promis Physical Function Questionnaire; Behavioral: L Test; Behavioral: Narrowing Beam Walking Test; Behavioral: PEQ-A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prosthesis Evaluation Questionnaire-Addendum (PEQ-A)
Fall incidence change between baseline and 6 months
Measured: 0, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start8 Jan 2024
- Primary completion1 Apr 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb TraumaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenton R. Kaufman, PhD, PE, Mayo Clinic
- Investigators
- Kenton Kaufman, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225792
- Sponsor's protocol ID
- 21-010009
- Status last verified
- Mar 2026
- First submitted
- 8 Dec 2021
- Last updated
- 19 Mar 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 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Training Method for Advanced Rehabilitation of Warfighters With Lower Extremity Trauma
- ClinicalTrials.gov ID
- NCT05225792
- Acronym / sponsor ID
- 21-010009
- Conditions
- Lower Limb Trauma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 7 Feb 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.
The purpose of this study is to find out if an advance balance perturbation training program can enhance the rehabilitation process by increasing weight-bearing strategies on the prosthetic or injured limb, and, help reduce stumbles and falls.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Injured Service Members | Experimental | Behavioral: Promis Physical Function Questionnaire, Behavioral: L Test, Behavioral: Narrowing Beam Walking Test, Behavioral: PEQ-A |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Research participants will be eligible active duty service members and retired veterans.
- Having lower limb trauma (transtibial and transfemoral amputations, bilateral amputations, and limb salvage).
- Are enrolled in conventional rehabilitation at the participating military treatment centers.
- Subjects with dysvascular disease will be excluded because compromised lower limb somatosensation and circulation are independently linked with poor postural stability and a history of frequent falls.
- For subjects with amputations, the individual must be a community ambulator (i.e., K-Level 3 or 4).
Key exclusion criteria (1 listed)
- Subjects must not have excessive pain or other neuromuscular problems that preclude them from performing the test protocol.
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 |
|---|---|---|
| Promis Physical Function QuestionnairePatient reported physical function outcomes | Behavioural | Injured Service Members |
| L TestPerformance based measure assessing general physical function and balance ability. | Behavioural | Injured Service Members |
| Narrowing Beam Walking TestSubjects attempt to walk along 4 progressively narrower beam segments with their arms crossed over their chest. | Behavioural | Injured Service Members |
| PEQ-AAlso: Prosthesis Evaluation Questionnaire - AddendumSurvey on confidence, stumbles and falls. | Behavioural | Injured Service Members |
Primary outcome
Prosthesis Evaluation Questionnaire-Addendum (PEQ-A)
Time frame: 0, 6 months
Fall incidence change between baseline and 6 months
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 19 Mar 2026.
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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.
Kenton Kaufman, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Promis Physical Function Questionnaire, L Test and Narrowing Beam Walking Test in people with Lower Limb Trauma, run by Mayo Clinic at 1 site in United States.
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 1 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: looking for participants now, as of the sponsor's last update on 19 Mar 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 United States. 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 Christine Huyber, CCRP ((507) 266-0984, Huyber.Christine@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prosthesis Evaluation Questionnaire-Addendum (PEQ-A) (time frame: 0, 6 months). 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 19 Mar 2026.