AmputationTOPLOADNCT05695911
Transfemoral Osseointegrated Prosthesis Limb-Load Symmetry Training
A study testing Limb Load Biofeedback Training Intervention in people with Amputation and Transfemoral Amputation, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This randomized controlled trial (n=25 enrolled, n=15 expected to complete) will 1) determine the feasibility of a 40-week limb-load biofeedback training intervention, 2) determine if there is an intervention signal of efficacy, and 3) identify functional movement priorities for people with transfemoral… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation, Transfemoral Amputation, Osseointegration
- What is being tested?
- Limb Load Biofeedback Training Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2023to 31 Jan 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
- Transfemoral unilateral amputation due to traumatic, congenital or cancer related causes
- ≥ 18 years old
- History of severe socket-related skin or residual limb problems
- Schedule for OI prosthesis implantation surgery
Who cannot join
- Vascular amputation etiology
- Substance abuse
- Unstable heart condition
- Acute systemic infection
- Cognitive impairment (Montreal Cognitive Assessment [MoCA] score <24)
- Active cancer treatment
Trial locations and contacts
1 site in 1 country.
About this study
This randomized controlled trial (n=25 enrolled, n=15 expected to complete) will 1) determine the feasibility of a 40-week limb-load biofeedback training intervention, 2) determine if there is an intervention signal of efficacy, and 3) identify functional movement priorities for people with transfemoral osseointegrated (OI) prostheses. A limb-load biofeedback training group (EXP (n=10)) will be compared to a standard of care attention-control group without limb-load biofeedback training (CTL (n=5)). Outcomes will be assessed at standard of care pre-habilitation end (Week 5), standard of care rehabilitation end (Week 24), and one year after OI Stage 2 surgery (Week 64).
Read the detailed description
This will be a randomized controlled trial with a limb-load biofeedback training (EXP) group and an attention control standard-of-care (CTL) group (2:1 allocation ratio). Outcomes will be assessed prior to surgery (Week 5), start of the limb-load biofeedback training (Week 24), and one year after surgery (Week 64). This Phase I clinical trial will be among the first randomized controlled rehabilitation trials for people with transfemoral OI prostheses. There is an immediate need to better understand the physical health benefits and factors that contribute to poor outcomes for this population. A critical step in developing rehabilitation guidelines is to identify optimal methods for people to regain active lifestyles, best use their prostheses, and avoid secondary comorbidities. This novel limb-load biofeedback training program will provide the empirical evidence necessary to inform post-OI rehabilitation regimens designed to optimize outcomes. Importantly, data from this trial will also guide intervention refinement as the investigators move toward a Phase II trial.
- Conditions
- Amputation, Transfemoral Amputation, Osseointegration
- Being tested
- Limb Load Biofeedback Training Intervention, Attention Control
- Keywords
- amputation, osseointegration, rehabilitation, biofeedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Limb Load Biofeedback Training InterventionBehavioural
Loadsol data will be used to inform the EXP telehealth sessions, as the interventionist guides the participant to self-monitor their movement, problem solve movement patterns that promote asymmetrical limb loading, and create weekly action plans for improving limb load symmetry. Weekly goals will be made in the context of functional task progression over the 40-week intervention.
Attention ControlOther
The 12 sessions of EXP group limb-load biofeedback training sessions will be replaced by education-only session in the CTL group. The CTL group sessions will include a review of the standard of care home-exercises, a summary of healthcare visits and falls, and interventionist-delivered education on safety topics (e.g., fall prevention, wound care, assistive device use, home safety).
| Study group | Role | What they receive |
|---|---|---|
| Limb Load Biofeedback Training Intervention | Experimental | The limb-load biofeedback training focuses on altering habitual movement patterns to promote proper prosthetic limb loading with an emphasis on between-limb loading symmetry. Participants randomized to the EXP group will receive 12 biofeedback training sessions (1 in-person, 11 telehealth) tapered over 40 weeks. Receives: Behavioral: Limb Load Biofeedback Training Intervention |
| Attention Control Intervention | Placebo comparator | The CTL group intervention will include the same standard of care rehabilitation sessions as the EXP group and receive the same computer tablets for telehealth sessions as the EXP group. The CTL group will also have attention control educational sessions at the same frequency, timing, and duration as the EXP group limb-load biofeedback sessions (12 total sessions) with the first session being an in-person session at the Week 24. There will be no biofeedback training intervention in the CTL group. As such, there will be no behavioral intervention or wearable sensors provided to the CTL group. The 12 sessions of EXP group limb-load biofeedback training sessions will be replaced by education-only session in the CTL group. Receives: Other: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Feasibility
Intervention feasibility is measured by retention rate, the percentage of people that complete the study. A score can range between 0 and 100 percent with 100 percent meaning all randomized participants completed the study.
Measured: Week 64
Intervention Participant Acceptability
Acceptability of an intervention is the perception among stakeholders (e.g., patients and clinicians) that the intervention is agreeable or satisfactory. To measure participant acceptability, the investigators will use the Acceptability of Intervention Measure, a 30 four-item survey of stakeholder perception of intervention acceptability that asks participants to provide their approval as well as intervention appeal, likability, and agreeability. The scores range from 1 (completely disagree) to 5 (completely agree). The investigators expect the Acceptability of Intervention Measure score (average of the four items on a 1-5 scale) for the EXP group to be at least 4 (agree).
Measured: Week 64
Intervention Fidelity
This will be evaluated based on whether EXP group interventionists deliver the intervention as planned and quantified in three ways: adherence, delivery quality, and patient engagement. The investigators will use the overall results of these three fidelity components to create a total score. Fidelity scores are reported as a percentage from 0 to 100 with 100 representing full fidelity. The investigators will consider >85% fidelity (average across all three components) to intervention delivery as a positive result.
Measured: Week 64
Change in Cumulative Loading
Free-living physical activity will be objectively monitored over a 10-day period using an activPAL micro accelerometer-based sensor (PAL Technologies, Glasgow, UK). Interlimb cumulative loading will be measured as a product of daily step count and ground reaction force impulse. Cumulative loading = (Daily Steps/2)*ground reaction force impulse.
Measured: Week 5, Week 64
Change in Multi-Domain Biomechanics during Tasks of Increasing Biomechanical Demand
Bilateral hip movement patterns (joint angles), muscle forces, and joint reaction forces will be calculated during functional tasks of increasing biomechanical demand (walking, sitting, stepping, turning) using a combination of motion capture and subject-specific musculoskeletal models. Whole-body motion capture will be collected from 70 reflective markers (Fs=120 Hz) (Vicon, Centennial, CO) with ground reaction forces simultaneously collected from six embedded force platforms (Fs=2,160 Hz) (Bertec, Columbus, OH). A subject-specific musculoskeletal model will be created using OpenSim software.
Measured: Week 5, Week 64
Secondary outcomes (7)
Change in World Health Organization-Disability Assessment Schedule 2.0
Self reported questionnaire measuring disability in adults age 18 years and older. Final scores range from 0 (no disability) to 100 (full disability).
Measured: Week 5, Week 24 and Week 64
Change in Activities Specific Balance Confidence Scale
Self reported measure of balance confidence. Final scores range from 0% (no confidence in balance) to 100% (complete confidence in balance).
Measured: Week 5, Week 24 and Week 64
Change in Prosthetic Limb Users Survey of Mobility
A 12 item self report questionnaire measuring participants mobility when using a prosthesis. Final scores range from 12 to 60 points with higher scores indicating greater mobility.
Measured: Week 5, Week 24 and Week 64
Change in Patient Specific Function Scale
Self reported questionnaire measuring the ability of the participant to do 3 self identified activities. Scores of each of the 3 activities range from 0 (unable to perform) to 10 (able to perform without difficulty). Total scores range from 0 to 30 points, with higher scores indicating higher function.
Measured: Week 5, Week 24 and Week 64
Change in Self Selected Gait Speed
Test to quantify walking ability as it is associated with health outcomes, fall risk, and mobility levels and is also a frequent indicator of intervention effectiveness. The time it takes each participant to walk 5-meters (after 3-meter acceleration zone, followed by 3-meter deceleration zone). The self selected gait speed will be averaged over three trials.
Measured: Week 5 and Week 64
Change in 30 Second Sit - Stand Test
Test to assess lower-extremity strength and endurance. The number of times the participant can rise from sitting in 30 seconds.
Measured: Week 5, Week 64
Change in Colorado Osseointegrated Limb Donning and Timed Up and Go Test
A specific test to measure physical function and balance. The time it takes a participant to don their prosthesis, rise from sitting, walk 10 feet and turn, walk back to the chair and return to seated position.
Measured: Week 5, Week 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start30 Jan 2023
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (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.
- More trials run by University of Colorado, DenverThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized by ratio of 1:2 in the CTL to EXP group.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Cory Christiansen, PT PHD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05695911
- Sponsor's protocol ID
- 22-2116
- Other IDs
- CDMRPOP220013
- Acronym
- TOPLOAD
- Status last verified
- Oct 2026
- First submitted
- 5 Jan 2023
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will publish the trial results data on the ClinicalTrials.gov website, on which the clinical trial will be registered. Sharing of data will include the potential of sharing raw data generated from all clinical assessments under a data-sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfemoral Osseointegrated Prosthesis Limb-Load Symmetry Training
- ClinicalTrials.gov ID
- NCT05695911
- Acronym / sponsor ID
- TOPLOAD / 22-2116
- Conditions
- Amputation, Transfemoral Amputation, Osseointegration
- Keywords
- amputation, osseointegration, rehabilitation, biofeedback
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 25 Jan 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 randomized controlled trial (n=25 enrolled, n=15 expected to complete) will 1) determine the feasibility of a 40-week limb-load biofeedback training intervention, 2) determine if there is an intervention signal of efficacy, and 3) identify functional movement priorities for people with transfemoral osseointegrated (OI) prostheses. A limb-load biofeedback training group (EXP (n=10)) will be compared to a standard of care attention-control group without limb-load biofeedback training (CTL (n=5)). Outcomes will be assessed at standard of care pre-habilitation end (Week 5), standard of care rehabilitation end (Week 24), and one year after OI Stage 2 surgery (Week 64).
Detailed description
This will be a randomized controlled trial with a limb-load biofeedback training (EXP) group and an attention control standard-of-care (CTL) group (2:1 allocation ratio). Outcomes will be assessed prior to surgery (Week 5), start of the limb-load biofeedback training (Week 24), and one year after surgery (Week 64). This Phase I clinical trial will be among the first randomized controlled rehabilitation trials for people with transfemoral OI prostheses. There is an immediate need to better understand the physical health benefits and factors that contribute to poor outcomes for this population. A critical step in developing rehabilitation guidelines is to identify optimal methods for people to regain active lifestyles, best use their prostheses, and avoid secondary comorbidities. This novel limb-load biofeedback training program will provide the empirical evidence necessary to inform post-OI rehabilitation regimens designed to optimize outcomes. Importantly, data from this trial will also guide intervention refinement as the investigators move toward a Phase II trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized by ratio of 1:2 in the CTL to EXP group.
| Arm | Type | Receives |
|---|---|---|
| Limb Load Biofeedback Training Intervention | Experimental | Behavioral: Limb Load Biofeedback Training InterventionThe limb-load biofeedback training focuses on altering habitual movement patterns to promote proper prosthetic limb loading with an emphasis on between-limb loading symmetry. Participants randomized to the EXP group will receive 12 biofeedback training sessions (1 in-person, 11 telehealth) tapered over 40 weeks. |
| Attention Control Intervention | Placebo comparator | Other: Attention ControlThe CTL group intervention will include the same standard of care rehabilitation sessions as the EXP group and receive the same computer tablets for telehealth sessions as the EXP group. The CTL group will also have attention control educational sessions at the same frequency, timing, and duration as the EXP group limb-load biofeedback sessions (12 total sessions) with the first session being an in-person session at the Week 24. There will be no biofeedback training intervention in the CTL group. As such, there will be no behavioral intervention or wearable sensors provided to the CTL group. The 12 sessions of EXP group limb-load biofeedback training sessions will be replaced by education-only session in the CTL group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Transfemoral unilateral amputation due to traumatic, congenital or cancer related causes
- ≥ 18 years old
- History of severe socket-related skin or residual limb problems
- Schedule for OI prosthesis implantation surgery
Key exclusion criteria (6 listed)
- Vascular amputation etiology
- Substance abuse
- Unstable heart condition
- Acute systemic infection
- Cognitive impairment (Montreal Cognitive Assessment [MoCA] score <24)
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 |
|---|---|---|
| Limb Load Biofeedback Training InterventionLoadsol data will be used to inform the EXP telehealth sessions, as the interventionist guides the participant to self-monitor their movement, problem solve movement patterns that promote asymmetrical limb loading, and create weekly action plans for improving limb load symmetry. Weekly goals will be made in the context of functional task progression over the 40-week intervention. | Behavioural | Limb Load Biofeedback Training Intervention |
| Attention ControlThe 12 sessions of EXP group limb-load biofeedback training sessions will be replaced by education-only session in the CTL group. The CTL group sessions will include a review of the standard of care home-exercises, a summary of healthcare visits and falls, and interventionist-delivered education on safety topics (e.g., fall prevention, wound care, assistive device use, home safety). | Other | Attention Control Intervention |
Primary outcome
Intervention Feasibility
Time frame: Week 64
Intervention feasibility is measured by retention rate, the percentage of people that complete the study. A score can range between 0 and 100 percent with 100 percent meaning all randomized participants completed the study.
Intervention Participant Acceptability
Time frame: Week 64
Acceptability of an intervention is the perception among stakeholders (e.g., patients and clinicians) that the intervention is agreeable or satisfactory. To measure participant acceptability, the investigators will use the Acceptability of Intervention Measure, a 30 four-item survey of stakeholder perception of intervention acceptability that asks participants to provide their approval as well as intervention appeal, likability, and agreeability. The scores range from 1 (completely disagree) to 5 (completely agree). The investigators expect the Acceptability of Intervention Measure score (average of the four items on a 1-5 scale) for the EXP group to be at least 4 (agree).
Intervention Fidelity
Time frame: Week 64
This will be evaluated based on whether EXP group interventionists deliver the intervention as planned and quantified in three ways: adherence, delivery quality, and patient engagement. The investigators will use the overall results of these three fidelity components to create a total score. Fidelity scores are reported as a percentage from 0 to 100 with 100 representing full fidelity. The investigators will consider >85% fidelity (average across all three components) to intervention delivery as a positive result.
Change in Cumulative Loading
Time frame: Week 5, Week 64
Free-living physical activity will be objectively monitored over a 10-day period using an activPAL micro accelerometer-based sensor (PAL Technologies, Glasgow, UK). Interlimb cumulative loading will be measured as a product of daily step count and ground reaction force impulse. Cumulative loading = (Daily Steps/2)*ground reaction force impulse.
Change in Multi-Domain Biomechanics during Tasks of Increasing Biomechanical Demand
Time frame: Week 5, Week 64
Bilateral hip movement patterns (joint angles), muscle forces, and joint reaction forces will be calculated during functional tasks of increasing biomechanical demand (walking, sitting, stepping, turning) using a combination of motion capture and subject-specific musculoskeletal models. Whole-body motion capture will be collected from 70 reflective markers (Fs=120 Hz) (Vicon, Centennial, CO) with ground reaction forces simultaneously collected from six embedded force platforms (Fs=2,160 Hz) (Bertec, Columbus, OH). A subject-specific musculoskeletal model will be created using OpenSim software.
7 secondary outcomes
Change in World Health Organization-Disability Assessment Schedule 2.0
Time frame: Week 5, Week 24 and Week 64
Change in Activities Specific Balance Confidence Scale
Time frame: Week 5, Week 24 and Week 64
Change in Prosthetic Limb Users Survey of Mobility
Time frame: Week 5, Week 24 and Week 64
Change in Patient Specific Function Scale
Time frame: Week 5, Week 24 and Week 64
Change in Self Selected Gait Speed
Time frame: Week 5 and Week 64
Change in 30 Second Sit - Stand Test
Time frame: Week 5, Week 64
Change in Colorado Osseointegrated Limb Donning and Timed Up and Go Test
Time frame: Week 5, Week 64
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 21 Oct 2026.
- Individual participant dataSharing planned: Yes. The investigators will publish the trial results data on the ClinicalTrials.gov website, on which the clinical trial will be registered. Sharing of data will include the potential of sharing raw data generated from all clinical assessments under a data-sharing agreement.
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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.
Cory Christiansen, PT PHD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Limb Load Biofeedback Training Intervention in people with Amputation and Transfemoral Amputation, run by University of Colorado, Denver 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 4 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 21 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 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. Some participants in this study may receive a placebo. 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?
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?
Intervention Feasibility (time frame: Week 64). The study lists 5 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 21 Oct 2026.