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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if people with leg amputations can improve their balance and fall recovery by watching demonstrations from other amputees rather than non-amputees. Researchers seek to discover whether observing peers enhances the learning of these skills and what occurs in the brain when watching different demonstrators. Participants will watch videos and attempt to learn balance and fall recovery tasks. This trial may suit individuals with a single leg amputation who regularly use a prosthetic leg and can stand unassisted for at least 5 minutes. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance rehabilitation techniques for amputees.

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 training is safe for individuals with leg amputation?

Research shows that balance and fall recovery training is generally safe for individuals who have lost a leg. Studies highlight the importance of balance training in rehabilitation, as it helps improve movement and reduces the risk of falls.

Although specific side effects are not detailed, the emphasis on enhancing balance and movement skills suggests minimal risks. The training includes watching video demonstrations, a low-risk and manageable activity.

Overall, for those considering joining a trial, current research suggests that balance and fall recovery training is safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to enhance balance and fall recovery skills for individuals with lower limb loss. Unlike traditional physical therapy, which often focuses on exercises led by a therapist, this trial uses video demonstrations as a learning tool. Participants watch short videos of either amputee peers or non-amputees performing balance and recovery tasks, which they then replicate. This method could offer a more relatable and flexible approach to rehabilitation, potentially improving engagement and outcomes for those with limb loss.

What evidence suggests that this training is effective for balance and fall recovery in individuals with leg amputation?

Research has shown that training in balance and fall recovery greatly benefits people with lower limb amputations. Studies indicate that watching real prosthesis demonstrations can enhance movement skills, particularly for those new to using a prosthetic limb. Balance training plays a crucial role in recovery after amputation, as it boosts confidence and ease of movement with a prosthetic. Additionally, balance exercises reduce the risk of falls and improve both static and dynamic balance while strengthening the lower body. In this trial, participants will experience two training conditions: learning from video demonstrations by amputee peers and learning from non-amputee models. This approach suggests that learning from other amputees through video demonstrations might be more effective than learning from non-amputee models. ^{3 5 6 7 8}

Who Is on the Research Team?

Szu-Ping Lee, PhD

Principal Investigator

University of Nevada, Las Vegas

Are You a Good Fit for This Trial?

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 am older than 18 years.

I have had one of my legs amputated.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10931137/

Outcomes of Patients with Lower Limb Loss after Using a ... The aim of this retrospective case series study was to investigate outcomes in patients with lower limb loss based on whether or not they used a training ...

2. oasis.library.unlv.edu oasis.library.unlv.edu/cgi/viewcontent.cgi?article=6226&context=thesesdissertations

Enhancing Motor Function in Individuals with Lower Limb ... This finding highlights the importance of using real prosthesis demonstrations for effective training, especially for new amputated individuals.

3. researchgate.net researchgate.net/profile/Christopher-Wong-8/publication/273784118_Role_of_balance_ability_and_confidence_in_prosthetic_use_for_mobility_of_people_with_lower-limb_loss/links/586bd51408aebf17d3a5af6f/Role-of-balance-ability-and-confidence-in-prosthetic-use-for-mobility-of-people-with-lower-limb-loss.pdf

Role of balance ability and confidence in prosthetic use for ... Balance training is an important component of reha- bilitation after amputation, and comprehensive rehabilita- tion for people with lower-limb loss incorporates ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10435089/

Effectiveness of exercise interventions on fall prevention in ... Balance exercises reduce the rate of injurious falls, improve static, dynamic and reactive balance, lower extremity strength as well as mobility. Multi- ...

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Fall Prevention Training for Service Members With an ... To address this research gap, we evaluated the success of a fall prevention training program for service members with lower extremity trauma by ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10443465/

Association Between Balance Self-efficacy and Walking ... Walking ability is related to self-efficacy of balance, however, this relationship has not been quantified for those with newly acquired lower limb amputations ...

7. mdpi.com mdpi.com/2227-9032/12/5/567

Outcomes of Patients with Lower Limb Loss after Using a ... The aim of this retrospective case series study was to investigate outcomes in patients with lower limb loss based on whether or not they used a training ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8594758/

Current and Emerging Trends in the Management of Fall Risk ... People living with lower limb amputation are at an increased risk of falling compared with the healthy geriatric population.