Limb Load Biofeedback Training for Osseointegration

(TOPLOAD Trial)

Overseen By Brecca Gaffney, PHD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Vascular amputation, Substance abuse, Unstable heart, others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 13

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new training method called limb-load biofeedback to assist individuals using a specific type of leg prosthesis. The goal is to determine if this method enhances movement and balance with prosthetic legs. Participants will receive either the new biofeedback training or standard care without it. Those who have had an above-knee amputation, plan to get an osseointegrated prosthesis, and have experienced serious issues with their current prosthetic socket might be suitable for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative solutions for improving mobility and quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that limb-load biofeedback training is safe for people with transfemoral osseointegrated prostheses?

Research has shown that Limb Load Biofeedback Training is generally safe. This training helps prevent excessive weight on the limbs during activities, which is crucial for those with transfemoral osseointegrated prostheses. No reports of serious side effects have emerged from this type of training. It focuses on altering movement patterns to ensure correct and even use of the prosthetic limb. Patients have responded well, indicating it is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Limb Load Biofeedback Training for osseointegration because it introduces a new method to enhance prosthetic limb use. Unlike traditional rehabilitation, which often focuses on general strength and mobility, this biofeedback training targets movement patterns to improve how prosthetic limbs bear weight, aiming for better symmetry between limbs. Utilizing a combination of in-person and telehealth sessions, this approach not only personalizes therapy but also makes it more accessible, potentially leading to more effective and faster recovery for amputees.

What evidence suggests that limb load biofeedback training is effective for osseointegration?

Research shows that limb load biofeedback training, which participants in this trial may receive, helps individuals with osseointegrated prostheses manage the weight on their artificial limb more effectively. This training alters movement patterns to ensure the prosthetic limb carries weight correctly, improving balance between the legs. Early results suggest this method enhances prosthetic limb use. Studies using pressure insoles indicate it distributes weight evenly between both legs, leading to better mobility and comfort for those with above-knee prostheses. ^{1 3 4 5 6}

Who Is on the Research Team?

Cory Christiansen, PhD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a single below-knee amputation from trauma, birth defects, or cancer. They should have had issues with prosthetic sockets and be scheduled for osseointegration surgery. It's not open to those with substance abuse, unstable heart conditions, vascular-related amputations, infections, cognitive impairments (MoCA score <24), or active cancer treatment.

Inclusion Criteria

I am scheduled for an implant surgery for my bone infection.

I have had serious skin or limb issues related to a prosthetic socket.

I have had one leg amputated above the knee due to injury, birth condition, or cancer.

Exclusion Criteria

My heart condition is stable.

Cognitive impairment (Montreal Cognitive Assessment [MoCA] score <24)

Substance abuse

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-habilitation

Standard of care pre-habilitation before surgery

5 weeks

1 visit (in-person)

Rehabilitation

Standard of care rehabilitation and limb-load biofeedback training

19 weeks

12 sessions (1 in-person, 11 telehealth)

Follow-up

Participants are monitored for safety and effectiveness after treatment

40 weeks

Regular telehealth sessions

Long-term Follow-up

Assessment of outcomes one year after OI Stage 2 surgery

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Attention Control
• Limb Load Biofeedback Training Intervention

Trial Overview The study tests a limb-load biofeedback training program against standard care without this feature in people getting transfemoral osseointegrated prostheses. The goal is to see if the training helps balance the load on limbs during rehabilitation over a period of up to one year post-surgery.

How Is the Trial Designed?

Group I: Limb Load Biofeedback Training Intervention Experimental Treatment 1 Intervention

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.

Group II: Attention Control Intervention Placebo Group 1 Intervention

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.

Limb Load Biofeedback Training Intervention is already approved in United States, European Union for the following indications:

Approved in United States as Limb Load Biofeedback Training for:

• Rehabilitation of transfemoral amputees with osseointegrated prostheses

Approved in European Union as Osseointegrated Prosthesis Limb-Load Symmetry Training for:

• Rehabilitation of transfemoral amputees with osseointegrated prostheses

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

A Finite Element model study showed that the current method of measuring vertical force during rehabilitation may not accurately reflect the actual stresses experienced by the bone-implant interface, potentially leading to higher and less uniform stresses than expected.

The research indicates that monitoring tri-axial loads during weight-bearing exercises is crucial for optimizing rehabilitation protocols for amputees with bone-anchored prostheses, as stress patterns differ significantly between static loading and dynamic walking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FE stress analysis of the interface between the bone and an osseointegrated implant for amputees--implications to refine the rehabilitation program. Lee, WC., Doocey, JM., Brånemark, R., et al.[2008]

The biofeedback sole effectively controls partial weight-bearing conditions during rehabilitation, as confirmed by testing with 17 healthy individuals and later with 50 volunteers using crutches.

Using the biofeedback sole significantly reduced the number of overloaded steps by 77%, demonstrating its efficacy in preventing overload during recovery, regardless of the user's body weight or age.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The biofeedback sole tested is a suitable device for avoiding overload under partial load]. Stangl, R., Krug, R., Hennig, FF., et al.[2018]

Starting rehabilitation just a few weeks after knee arthroplasty leads to better recovery outcomes compared to starting rehabilitation three months post-surgery, as shown in a study of 18 patients.

The use of biofeedback devices during rehabilitation helps patients regain conscious control of their movements, which is particularly beneficial for those experiencing abnormal sensory feedback after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The application of biofeedback exercises in patients following arthroplasty of the knee with the use of total endoprosthesis. Wilk-Frańczuk, M., Zemła, J., Sliwiński, Z.[2011]

Training methods using feedback systems to limit weight bearing on a protected limb were found to be largely ineffective, as subjects often exceeded target loads by 50% or more during and after training.

Retention of any learning from the training diminished quickly, with significant overshooting of target loads occurring due to delays in motor response to auditory feedback.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training procedures and biofeedback methods to achieve controlled partial weight bearing: an assessment. Warren, CG., Lehmann, JF.[2013]

The study provides detailed loading characteristics of transfemoral osseointegrated implants during daily activities, which can help improve the design of prosthetic components and clinical interventions for individuals with lower limb loss.

The data highlights variability in loading patterns among participants, offering critical insights for future research and development of algorithms to better understand and optimize prosthetic care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Loading characteristics data applied on osseointegrated implant by transfemoral bone-anchored prostheses fitted with state-of-the-art components during daily activities. Frossard, L., Laux, S., Geada, M., et al.[2022]

The study demonstrated that using biofeedback in a controlled exercise program significantly improved muscle bulk and suspension capabilities in below-knee amputees, with marked improvements in two out of four participants.

These findings suggest that incorporating muscle training for the residual limb should be a standard part of physical therapy for below-knee amputees, as it can enhance prosthetic design and functionality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of isometric muscle training on residual limb volume, strength, and gait of below-knee amputees. Kegel, B., Burgess, EM., Starr, TW., et al.[2022]

Biofeedback training significantly improves compliance with weight-bearing instructions, as shown by a study of 12 participants who were able to maintain proper weight-bearing levels for up to 24 hours after training.

Participants who received only verbal instructions consistently bore much more weight than recommended, highlighting the effectiveness of biofeedback in ensuring adherence to weight-bearing guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lower-extremity weight-bearing compliance is maintained over time after biofeedback training. Hustedt, JW., Blizzard, DJ., Baumgaertner, MR., et al.[2012]

This proof-of-concept study introduced a new apparatus using a three-dimensional load transducer to directly measure the load on osseointegrated implants in transfemoral amputees during static exercises, providing valuable data for clinicians.

The study found that as the load increased from 10 kg to 80 kg, the forces on the fixation increased significantly, indicating that the current methods of monitoring load may not accurately reflect the stresses experienced by the implant, which could inform better rehabilitation practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apparatus for monitoring load bearing rehabilitation exercises of a transfemoral amputee fitted with an osseointegrated fixation: a proof-of-concept study. Frossard, L., Gow, DL., Hagberg, K., et al.[2022]

In a study involving six individuals with transtibial amputation, the use of audio biofeedback significantly helped in monitoring and controlling weight-bearing activities during early postoperative training.

Without audio biofeedback, participants risked overloading their residual limb when using conventional methods, highlighting the importance of this technology in preventing injury and promoting safe recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative analysis of the effects of audio biofeedback on weight-bearing characteristics of persons with transtibial amputation during early prosthetic ambulation. Chow, DH., Cheng, CT.[2022]

In a study of 24 older adults (ages 61-80), using real-time biofeedback significantly improved their ability to maintain proper weight bearing while walking with forearm crutches, reducing excessive loads over 30 kg on level ground and stairs.

The traditional method of using a bathroom scale was largely ineffective, with over half of the participants exceeding the target weight range, highlighting the need for tailored rehabilitation strategies for elderly patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can elderly individuals perform partial weight bearing on their lower limbs? A prospective cohort study using ambulatory real-time biofeedback. Merkle, TP., Hofmann, N., Knop, C., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05695911

Transfemoral Osseointegrated Prosthesis Limb-Load ... The limb-load biofeedback training focuses on altering habitual movement patterns to promote proper prosthetic limb loading with an emphasis on between-limb ...

2. ctv.veeva.com ctv.veeva.com/study/transfemoral-osseointergrated-prosthesis-limb-load-symmetry-training

Transfemoral Osseointegrated Prosthesis Limb-Load ... The limb-load biofeedback training focuses on altering habitual movement patterns to promote proper prosthetic limb loading with an emphasis on between-limb ...

3. apps.dtic.mil apps.dtic.mil/sti/trecms/pdf/AD1229688.pdf

SF 298, Report Documentation Page - DTIC Limb-load symmetry biofeedback training via pressure insoles in patients with osseointegrated prostheses. Primary Outcomes: 1) Intervention feasibility and 2) ...

4. withpower.com withpower.com/trial/limb-load-biofeedback-training-for-osseointegration-2cf0a

Limb Load Biofeedback Training for Osseointegration This suggests that Limb Load Biofeedback Training could be effective in helping patients with osseointegrated prostheses manage their limb load more accurately ...

5. trial.medpath.com trial.medpath.com/clinical-trial/ecb79a9a02a08a11/nct05695911-transfemoral-osseointegrated-prosthesis-limb-load-symmetry-training

Transfemoral Osseointegrated Prosthesis Limb-Load Symmetry ... 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 ...

6. trialx.com trialx.com/clinical-trials/listings/252734/transfemoral-osseointegrated-prosthesis-limb-load-symmetry-training/

Transfemoral Osseointegrated Prosthesis Limb-Load ... 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) ...