Balance and Fall Recovery Training for Amputation

Overseen By Joel Snyder, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Nevada, Las Vegas

Disqualifiers: CNS diseases, Leg/foot ulcer, Cardiovascular, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The overall goal of this research project is to investigate the effectiveness and the science of peer-based prosthetic skill training in individuals with leg amputation. Our belief is that amputee learners will show improved skill learning when observing demonstrations from other amputees, as opposed to observing nonamputee models. The investigators will accomplish the objective by answering the following two questions: Question 1: Does peer-based observation training works better for learning motor tasks for individuals with lower limb amputation (LLA)? Question 2: Are there differences in visual focus, behavior, and brain activation patterns when observing motor task demonstrations from amputee peers vs. non-amputees? Participants of this study will be asked to learn a balance and a fall recovery task by observing video demonstrations by amputee peers vs. non-amputees. The investigators will compare which setting produce better learning.

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 Balance and Fall Recovery Training for Amputation?

Research shows that balance training can improve standing time on a prosthetic leg and reduce the time needed to complete mobility tasks, indicating better balance and movement abilities in people with lower limb amputations. Additionally, compensatory-step training helps amputees improve their ability to recover from postural disturbances, which can prevent falls. ^{1 2 3 4 5}

Is balance and fall recovery training safe for amputees?

The studies suggest that balance and fall recovery training is generally safe for amputees, as participants improved their ability to recover from falls without injury, and safety measures like harnesses were used to prevent falls during training. ^{1 2 3 5 6}

How does the treatment Balance and Fall Recovery Training for Amputation differ from other treatments for this condition?

Balance and Fall Recovery Training for Amputation is unique because it focuses on improving balance and coordination skills specifically for people with lower limb amputations, using a specialized mechanical apparatus for safe practice. This approach is distinct from other treatments as it directly targets the challenges of standing and walking with a prosthetic limb, enhancing confidence and reducing the risk of falls. ^{1 2 3 4 7}

Research Team

Szu-Ping Lee, PhD

Principal Investigator

University of Nevada, Las Vegas

Eligibility Criteria

This trial is for individuals with lower limb amputation who are interested in improving their balance and fall recovery skills. Participants should be willing to learn motor tasks by observing video demonstrations from both amputee peers and non-amputees.

Inclusion Criteria

I can stand for 5 minutes without help or feeling very tired.

I have had one of my legs amputated.

I am older than 18 years.

Exclusion Criteria

I have a brain condition affecting my movement or balance.

I have health issues that prevent me from doing moderate exercise.

I have a painful leg or foot ulcer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Participants undergo a 2-week training period to learn balance and fall recovery tasks by observing video demonstrations from amputee peers vs. non-amputees.

2 weeks

At least 3 sessions

Cross-over Training

Participants are exposed to the alternate training condition after a 4-week washout period, learning from the other group of demonstrators.

3 months

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after training, including assessments of balance and fall recovery performance.

4 weeks

Treatment Details

Interventions

• Balance and fall recovery training

Trial Overview The study aims to determine if learning motor tasks like balance and fall recovery is more effective when training is demonstrated by fellow amputees rather than non-amputees. It will also explore differences in attention, behavior, and brain activity during the learning process.

Participant Groups

Group I: Non-amputees Experimental Treatment 1 Intervention

In this arm, participants with lower limb loss are instructed to learn from video demonstrations by non-amputees. The videos will show balance and fall recovery movement tasks performed by the models, 15-30 seconds in length. The instruction to the participants is: "Please watch and learn the tasks as performed by the demonstrator. You (the participant) will be asked to perform these tasks later."

Group II: Amputee peers Experimental Treatment 1 Intervention

This research uses a cross-over design to expose the participants with lower limb loss to the two training conditions (observing amputee peers vs. non-amputees) in random order, with a 4-week washout period between conditions. In this arm, participants are instructed to learn from video demonstrations by amputee peers. The videos will show balance and fall recovery movement tasks performed by the models, 15-30 seconds in length. The instruction to the participants is: "Please watch and learn the tasks as performed by the demonstrator. You (the participant) will be asked to perform these tasks later."

Who Is Running the Clinical Trial?

University of Nevada, Las Vegas

Lead Sponsor

Trials

81

Recruited

14,700+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Findings from Research

A balance-training program using the BalanceReTrainer significantly improved balancing and ambulation skills in 14 individuals with trans-tibial amputations, with measurable improvements in standing duration, timed up and go test, and 10m walk times after just five days of training.

Participants increased their ability to stand on their prosthetic leg from an average of 2.98 seconds to 4.3 seconds, and their performance in the timed up and go test improved from 6.15 seconds to 5.4 seconds, demonstrating the efficacy of the training intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic balance training during standing in people with trans-tibial amputation: a pilot study. Matjaĉić, Z., Burger, H.[2022]

Compensatory-step training for individuals with unilateral amputations showed significant improvements in their ability to recover from postural disturbances, helping them avoid falls during six training sessions with five participants.

The training led to better body mechanics, such as reduced trunk flexion and increased distance between the body center of mass and the stepping foot, although some kinematic variables like step length did not show improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compensatory-step training of healthy, mobile people with unilateral, transfemoral or knee disarticulation amputations: A potential intervention for trip-related falls. Crenshaw, JR., Kaufman, KR., Grabiner, MD.[2022]

In a study comparing 17 unilateral transtibial amputees to 17 able-bodied individuals, amputees demonstrated faster response times and shorter intervals between heel-strikes when leading with their prosthetic limb during balance recovery after a fall.

Despite differences in limb use, amputees showed similar dynamic stability in recovering from falls compared to able-bodied controls, suggesting that rehabilitation should focus on training balance recovery with both limbs to enhance confidence in fall-prone situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Balance recovery after an evoked forward fall in unilateral transtibial amputees. Curtze, C., Hof, AL., Otten, B., et al.[2022]

In a randomized controlled trial with 20 transfemoral amputees, dual-task balance training significantly improved balance, functional mobility, and gait speed compared to traditional single-task training, indicating its efficacy in rehabilitation.

Additionally, the dual-task training group experienced notable improvements in cognitive function and sleep quality, suggesting that incorporating cognitive challenges during physical training can enhance overall rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigation of the Effects of Dual-Task Balance Training on Gait and Balance in Transfemoral Amputees: A Randomized Controlled Trial. Demirdel, S., Erbahçeci, F.[2022]

A study involving 27 individuals with lower extremity amputations revealed that while participants recognized unsafe behaviors and lack of attention as major falls risk factors, only a small percentage (5.9%) identified preventative behavioral modifications, indicating a gap in applying knowledge to prevent falls.

Despite the lived experience of rehabilitation, there were no significant changes in participants' balance confidence or knowledge of falls risk factors from discharge to a 4-month follow-up, suggesting that rehabilitation programs need to focus more on translating knowledge into effective falls prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating knowledge of falls risk factors and falls prevention strategies among lower extremity amputees after inpatient prosthetic rehabilitation: a prospective study. Hunter, SW., Higa, J., Frengopoulos, C., et al.[2021]

The study developed a safe and effective method to induce unexpected trips in lower-limb amputees, using a polypropylene wire and a safety harness to prevent falls, allowing for the analysis of balance recovery responses.

Results showed that recovery strategies differed based on which limb was tripped; participants could adjust their movements to recover from trips on their sound limb but struggled to do so when tripped on their prosthetic limb, highlighting the need for improved prosthetic design to enhance balance recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Experimental Approach to Induce Trips in Lower-Limb Amputees. Rodacki, ALF., Buckley, JG., Passos de Oliveira, AC., et al.[2023]

In a study of 64 deep burn patients with lower limb dysfunction, balance training significantly improved balance scores and lower limb function compared to routine training alone after 4 months of treatment.

Patients who underwent balance training also reported higher self-confidence in their balance activities, indicating that this type of training not only enhances physical recovery but also boosts psychological well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A prospective randomized controlled study on the effect of balance training on lower limb movement and balance dysfunction in severe burn patients]. Ru, TF., Li, FF., Xie, WG., et al.[2021]

References

1. France pubmed.ncbi.nlm.nih.gov

Dynamic balance training during standing in people with trans-tibial amputation: a pilot study. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Compensatory-step training of healthy, mobile people with unilateral, transfemoral or knee disarticulation amputations: A potential intervention for trip-related falls. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Balance recovery after an evoked forward fall in unilateral transtibial amputees. [2022]

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

Investigation of the Effects of Dual-Task Balance Training on Gait and Balance in Transfemoral Amputees: A Randomized Controlled Trial. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Evaluating knowledge of falls risk factors and falls prevention strategies among lower extremity amputees after inpatient prosthetic rehabilitation: a prospective study. [2021]

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

An Experimental Approach to Induce Trips in Lower-Limb Amputees. [2023]

7. China pubmed.ncbi.nlm.nih.gov

[A prospective randomized controlled study on the effect of balance training on lower limb movement and balance dysfunction in severe burn patients]. [2021]