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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Advance Balance Perturbation Training Program, Reactive Balance Training, Perturbation-Based Training, Perturbation-Induced Training?

Research shows that perturbation-based balance training can improve balance and reduce fall risk in older adults and people with chronic stroke. This type of training helps improve the quality of stepping responses, which are important for maintaining balance and preventing falls. ^{1 2 3 4 5}

Is perturbation-based balance training safe for humans?

Perturbation-based balance training has been studied for improving balance and reducing falls, especially in older adults and people with stroke. The training is generally considered safe when conducted under controlled conditions, such as using computer-controlled platforms or bicycle simulators, which help ensure safety during exercises. ^{1 2 3 4 6}

How is the Advance Balance Perturbation Training Program different from other treatments for lower limb injury?

The Advance Balance Perturbation Training Program is unique because it focuses on improving balance and stability through controlled, unexpected movements (perturbations) to help the body learn to react better to sudden changes, which is not a common focus in traditional rehabilitation therapies for lower limb injuries. ^{1 2 3 4 7}

Research Team

Kenton Kaufman, PhD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Perturbation-based balance training: Principles, mechanisms and implementation in clinical practice. [2023]

2. England 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. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Perturbation-Based Balance Training to Improve Step Quality in the Chronic Phase After Stroke: A Proof-of-Concept Study. [2020]

4. England pubmed.ncbi.nlm.nih.gov

A systematic review of perturbation-based balance training on reducing fall risk among individuals with stroke. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Specific Stimuli Induce Specific Adaptations: Sensorimotor Training vs. Reactive Balance Training. [2022]

6. Switzerland 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. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

A single session of perturbation-based gait training with the A-TPAD improves dynamic stability in healthy young subjects. [2018]