Rapid Rehabilitation for Lower Limb Injury

Overseen By Christine Huyber, CCRP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Dysvascular disease, excessive pain, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Advance Balance Perturbation Training Program can accelerate recovery for individuals with lower limb injuries, such as amputations or severe leg trauma. The program seeks to enhance participants' ability to bear weight on their injured or prosthetic limb and reduce the risk of stumbles and falls. Ideal candidates include active duty service members or retired veterans currently undergoing rehabilitation at specific military centers. Individuals with vascular diseases or excessive pain are not eligible. As an unphased trial, this study provides a unique opportunity to contribute to innovative rehabilitation techniques that could improve recovery outcomes for many.

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 this advance balance perturbation training program is safe for injured service members?

Research has shown that the Advance Balance Perturbation Training Program is generally safe for participants. This training involves quick movements to help individuals regain balance and is well-tolerated by most people. One study found that while the program is safe, it did not significantly improve certain physical abilities like balance or strength. Another study found that the training can reduce the risk of falls and improve posture and walking control. These findings suggest that the training is unlikely to cause major side effects, though it might not lead to significant changes in physical abilities. Overall, the training is considered safe, but the benefits may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Advance Balance Perturbation Training Program is unique because it focuses on enhancing balance and stability for those recovering from lower limb injuries, which is a departure from traditional rehabilitation methods like physical therapy that emphasize strength and flexibility. This program challenges the body's balance systems in a controlled manner, potentially speeding up recovery and improving coordination faster than conventional approaches. Researchers are excited about this technique because it could lead to more effective and rapid rehabilitation for injured service members, helping them return to their duties more quickly and with greater confidence.

What evidence suggests that the Advance Balance Perturbation Training Program is effective for lower limb injury rehabilitation?

Research has shown that balance training, which involves practicing how to stay steady during sudden movements, can help prevent falls. One study found that this training reduced falls by 23%. It helps the body react and maintain balance during unexpected changes in movement, which is especially important for individuals with leg injuries. Although some studies suggest it might not always work in everyday situations, this training is generally considered helpful for improving balance and stability. This trial explores whether the Advance Balance Perturbation Training Program can also aid in faster recovery for those with prosthetic or injured limbs. ^{1 2 5 6 7}

Who Is on the Research Team?

Kenton Kaufman, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for active duty service members and retired veterans who are community ambulators with lower limb trauma, including certain amputations or limb salvage. They must be enrolled in conventional rehab at military centers and not have excessive pain or neuromuscular issues that would prevent participation.

Inclusion Criteria

I can walk independently in the community despite my amputation.

I use an IDEO brace and am in the Return-to-Run program after limb salvage surgery.

Research participants will be eligible active duty service members and retired veterans

Exclusion Criteria

Subjects must not have excessive pain or other neuromuscular problems that preclude them from performing the test protocol

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an advanced balance perturbation training program to enhance rehabilitation by increasing weight-bearing strategies on the prosthetic or injured limb

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on fall incidence

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Advance Balance Perturbation Training Program

Trial Overview The study tests an advanced balance training program aimed at improving weight-bearing on injured limbs to reduce stumbles and falls. Participants will undergo assessments like the Promis Physical Function Questionnaire and various walking tests to measure progress.

How Is the Trial Designed?

Group I: Injured Service Members Experimental Treatment 4 Interventions

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

Perturbation-based balance training is emerging as a promising method for preventing falls in older adults, focusing on task-specific training that may lead to better adaptation and retention of balance skills.

While the approach shows potential efficacy, further research is needed to address safety concerns and practical implementation issues before it can be widely adopted in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perturbation-based balance training: Principles, mechanisms and implementation in clinical practice. McCrum, C., Bhatt, TS., Gerards, MHG., et al.[2023]

A review of nine studies involving 364 participants found insufficient evidence that perturbation-based balance training effectively reduces falls in individuals with stroke.

The training protocols varied widely among studies, leading to inconsistent results regarding the impact of this training on common fall risk factors, highlighting the need for more high-quality research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of perturbation-based balance training on reducing fall risk among individuals with stroke. Brown, D., Simpkins, C., Yang, F.[2023]

A single training session using the Active Tethered Pelvic assisted Device (A-TPAD) significantly improved balance control in eight healthy young participants by enhancing their stability during walking after exposure to waist-pull perturbations.

Participants adapted their balance strategies, showing increased stability in response to diagonal perturbations, which suggests that this training could be effective in reducing fall risk, especially in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A single session of perturbation-based gait training with the A-TPAD improves dynamic stability in healthy young subjects. Martelli, D., Kang, J., Agrawal, SK.[2018]

A new Perturbation-Based-Balance Training (PBBT) program using hands-free bicycling is being tested on 68 pre-frail older adults to improve their balance and reduce fall risks, addressing a critical need for those who cannot participate in traditional balance training.

The study aims to determine if balance skills learned while sitting can be transferred to standing and walking, potentially helping frail older adults improve their reactive and proactive balance responses in real-life situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Bicycle Simulator Training on Anticipatory and Compensatory Postural Control in Older Adults: Study Protocol for a Single-Blind Randomized Controlled Trial. Batcir, S., Lubovsky, O., Bachner, YG., et al.[2021]

Training with treadmill perturbations in the anterior-posterior direction significantly improved recovery responses in older adults, indicating that this type of training can enhance dynamic stabilization of the trunk.

Both groups in the study showed improved recovery from perturbations in both anterior-posterior and medio-lateral directions immediately after training and one week later, suggesting that the benefits of the training were retained over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transfer and retention effects of gait training with anterior-posterior perturbations to postural responses after medio-lateral gait perturbations in older adults. Rieger, MM., Papegaaij, S., Pijnappels, M., et al.[2021]

Both static (SMT) and reactive (RBT) balance training significantly reduced postural sway in participants, but the effectiveness varied depending on the training method used, with the greatest improvements seen when the training matched the testing conditions.

RBT led to greater reductions in co-contraction indices of thigh muscles compared to SMT's effects on shank muscles, highlighting that different balance training modalities produce specific neuromuscular adaptations that can enhance fall prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Specific Stimuli Induce Specific Adaptations: Sensorimotor Training vs. Reactive Balance Training. Freyler, K., Krause, A., Gollhofer, A., et al.[2022]

A 5-week perturbation-based balance training program on a movable platform significantly improved reactive step quality in 20 individuals with chronic stroke, with better leg angles observed immediately after training and retained at a 6-week follow-up.

Participants also demonstrated increased side stepping ability, taking 39% more steps with their affected leg and 46% more with their unaffected leg, suggesting enhanced balance and mobility post-intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perturbation-Based Balance Training to Improve Step Quality in the Chronic Phase After Stroke: A Proof-of-Concept Study. van Duijnhoven, HJR., Roelofs, JMB., den Boer, JJ., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9583884/

Perturbation-based balance training: Principles, mechanisms ... Perturbation-based balance training has been gaining interest as an efficient and effective way to prevent falls in older adults.

2. withpower.com withpower.com/trial/phase-wounds-and-injuries-5-2022-84523

Rapid Rehabilitation for Lower Limb Injury The purpose of this study is to find out if an advance balance perturbation training program can enhance the rehabilitation process by increasing ...

3. medrxiv.org medrxiv.org/content/10.1101/2025.07.23.25331962v1.full-text

Perturbation-based balance training improves reactive ... Meta-analyses showed that PBT significantly reduced: fall rate by 23% (rate ratio 0.77, 95% CI [confidence interval]: 0.60–0.99, I2=57%, low ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04820777

Effects Of Perturbation Based Balance Training in Reactive ... A structured online system, such as the ClinicalTrials.gov results database, that provides the public with access to registration and summary results ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0268003323002097

A systematic review of perturbation-based balance training ... The results indicated insufficient evidence supporting that perturbation-based balance training reduces falls in the laboratory and everyday living conditions ...

6. physio-pedia.com physio-pedia.com/Perturbation-Based_Balance_Training

Perturbation-Based Balance Training These perturbations elicit rapid postural responses, training reactive postural control. PBT reduces fall risk, improves postural control and gait in many ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8329312/

Safety and Effectiveness of a Perturbation-based ... The perturbation-based NM training was safe, but showed no significant improvement in dynamic balance, strength, proprioception, or flexibility ...