Balance and Fall Recovery Training for Amputation
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Nevada, Las Vegas
Disqualifiers: CNS diseases, Leg/foot ulcer, Cardiovascular, others
No Placebo Group
Approved in 1 Jurisdiction
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.
12345Is 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.
12356How 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.
12347Eligibility 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.
+2 more
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.
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Non-amputeesExperimental Treatment1 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 peersExperimental Treatment1 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."
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Nevada, Las VegasLas Vegas, NV
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Who Is Running the Clinical Trial?
University of Nevada, Las VegasLead Sponsor
United States Department of DefenseCollaborator
References
Dynamic balance training during standing in people with trans-tibial amputation: a pilot study. [2022]Falls and fear of falling are significant problems arising from impaired balancing abilities that affect people with lower limb amputation during unassisted transfer manoeuvres and ambulation. It is important to develop and evaluate efficient therapeutic interventions aimed at improving balancing and coordination skills. A group of 14 persons after trans-tibial amputation, fitted with trans-tibial prostheses, were included in a balance-training programme, consisting of approximately 20 minutes of balance training per day for five consecutive days on BalanceReTrainer--a novel balance-training, fall-safe mechanical apparatus. Before and after the training period three outcome measures were taken: duration of standing only on the prosthetic leg, timed up and go test and 10m walk. Each measurement was repeated five times and the mean value was used in the subsequent calculation of mean values and standard deviations for the group. Before training the group was able to stand on the prosthetic leg for 2.98 +/- 2.75s, they needed 6.15 +/- 1.9s for accomplishing timed up and go test and they needed 5.51 +/- 1.5s to cover the distance of 10m. After the treatment period the values were 4.3 + 4.5s, 5.4 +/- 1.5s and 4.5 +/- 0.9s, respectively. The results indicate improved performance in all three measured tasks, thereby indicating that the applied treatment programme improves balancing and ambulation abilities in people after trans-tibial amputation.
Compensatory-step training of healthy, mobile people with unilateral, transfemoral or knee disarticulation amputations: A potential intervention for trip-related falls. [2022]The purpose of this study was to evaluate the effects of compensatory-step training of healthy, mobile, young-to-middle aged people with unilateral, transfemoral or knee disarticulation amputations. Outcomes of interest included recovery success, reliance on the prosthesis, and the kinematic variables relevant to trip recovery. Over the course of six training sessions, five subjects responded to postural disturbances that necessitated forward compensatory steps to avoid falling. Subjects improved their ability to recover from these postural disturbances without falling or hopping on the non-prosthetic limb. Subjects improved their compensatory stepping response by decreasing trunk flexion and increasing the sagittal plane distance between the body center of mass and the stepping foot. In response to more challenging disturbances, these training-related improvements were not observed for the initial step with the non-prosthetic limb. Regardless of the stepping limb, step length and the change in pelvic height were not responsive to training. This study exhibits the potential benefits of a compensatory-step training program for amputees and informs future improvements to the protocol.
Balance recovery after an evoked forward fall in unilateral transtibial amputees. [2022]Falls are a common and potentially dangerous event, especially in amputees. In this study, we compared the mechanisms of balance recovery of 17 unilateral transtibial amputees and 17 matched able-bodied controls after being released from a forward-inclined orientation of 10%. Kinematic analysis revealed statistically significant differences in response time and knee flexion at heel-strike between both groups. However, there were no statistically significant differences in step length of the leading and trailing limb, swing time of the leading limb, and maximal knee flexion during swing. In the amputees, we found spatial and temporal differences when recovering with the sound versus prosthetic limb first. When leading with the prosthetic limb, they responded faster and also the interval between heel-strike of the leading and trailing limb was shorter. Furthermore, amputees made a longer step and showed less knee flexion at heel-strike when leading with the prosthetic limb. Interestingly, amputees as a group had no specific limb preference, prosthetic or sound, to recover after a forward fall, despite the asymmetry in their locomotor system. Analyses of dynamic stability (extrapolated center of mass) revealed that the amputees were equally efficient in recovering from an impending fall as controls, irrespective whether they lead with their prosthetic or sound limb. We suggest that in amputee rehabilitation, balance recovery after a fall should be trained with both sides, as this can increase confidence in fall-prone situations.
Investigation of the Effects of Dual-Task Balance Training on Gait and Balance in Transfemoral Amputees: A Randomized Controlled Trial. [2022]To investigate the effects of dual-task balance training on static and dynamic balance, functional mobility, cognitive level, and sleep quality in individuals with transfemoral amputation.
Evaluating knowledge of falls risk factors and falls prevention strategies among lower extremity amputees after inpatient prosthetic rehabilitation: a prospective study. [2021]Purpose: Falls are prevalent among people with lower extremity amputations. A knowledge of risk factors is important in preventing falls, though no research has evaluated patient understanding of falls in this population. The study objective was to evaluate knowledge of falls risk factors and falls prevention strategies at discharge and 4-months after inpatient prosthetic rehabilitation.Methods: Participants completed a falls questionnaires with four sections: (1) falls during rehabilitation and after discharge, (2) falls self-efficacy using the Activities-specific Balance Confidence scale, (3) knowledge of falls risk factors, and (4) falls prevention strategies. Questionnaire responses were quantified using means and standard deviations or frequencies and percentages. Data were analyzed using paired t-tests for the Activities-specific Balance Confidence scale and the knowledge of falls risk factors, and using chi-square analyses for fall prevention strategies.Results: Twenty-seven individuals (aged 62.6 ± 8.4; 55.6% male) were included. Unsafe or risky behaviours and not paying attention to surroundings were perceived as the top two falls risk factors. Although these factors are modifiable, only 5.9% of participants listed preventative behavioural modifications. No significant differences were found in Activities-specific Balance Confidence scale scores (p = 0.404) or knowledge of falls risk factors (p = 0.361) between discharge and follow-up.Conclusion: This study highlights a gap between knowledge of falls risk factors and the application of knowledge to prevent falls. Follow-up data suggest that lived experience does not affect the knowledge of falls risk factors.IMPLICATIONS FOR REHABILITATIONFalls and falls prevention are an important health concern for those with lower extremityamputations and should be addressed during the rehabilitation process.Balance confidence among individuals with lower extremity amputations is low, indicating that this population is at an increased falls risk and may require intervention to prevent falls.Rehabilitation programs should encourage all forms of falls prevention modifications and strategies, such as behavioural modifications, physical activity and environmental modifications.There is a gap between knowledge of falls risk factors and how to apply this to prevent falls, which may be a target for rehabilitation.
An Experimental Approach to Induce Trips in Lower-Limb Amputees. [2023]Reestablishing balance after a trip is challenging for lower-limb amputees and often results in a fall. The effectiveness of reestablishing balance following a trip depends on factors such as amputation level (transtibial or transfemoral) or which limb is tripped (prosthetic or sound/lead or trailing). Understanding the recovery responses can help identify strategies to avoid a trip becoming a fall and what trip-response functionality could be designed into a prosthesis. This study presents an experimental approach for inducing unexpected trips in individuals with amputation. Tripping was manually triggered by activating an electromagnetic device to raisea polypropylene wire to obstruct (bring to a near halt) theswinging limb during its mid-swing phase. A safety harness attached to a ceiling rail ensured participants did not hit the ground if they failed to reestablish balance following the trip (i.e., it prevented a fall from occurring). One transtibial amputee completed repeated walking trials in which a trip was induced around 1 out of 15 times to avoid it being anticipated. 3D kinematics were determined via two smartphones (60Hz) using the OpenCap software, highlighting that the experimental approach induced meaningful tripping/recovery responses dependent on which limb was tripped (prosthetic or sound). The presented methodology avoids using a rigid obstacle, potentially reducing the risk of injuries, and is inexpensive and easy to set up. Importantly it permits a trip to be unexpectedly introduced during the mid-swing phase of the gait and hence provides an approach for identifying real-world trip recovery responses. When tripping the sound limb, participants could 'disentangle' from the trip-wire (post-trip) by plantarflexing the ankle, but such action was not possible when tripping the prosthetic limb.
[A prospective randomized controlled study on the effect of balance training on lower limb movement and balance dysfunction in severe burn patients]. [2021]Objective: To observe the rehabilitation effect of balance training on motor and balance function of lower extremities of deep burn patients. Methods: A prospective randomized controlled study was conducted. From January 2016 to January 2020, sixty-four patients with lower limb motor and balance dysfunction after deep burn were admitted to Tongren Hospital of Wuhan University＆Wuhan Third Hospital, the burn area was 30% to 70% Total Body Surface Area, and the burn depth of more than one hip, knee and ankle joint of both lower limbs and their periphery were deep second or third degree. According to the method of random number table, the patients were divided into routine training(RT) group and balance training(BT) group. There were 32 cases in each group, 22 males and 10 females in the RT group, aged 40.5 (35.5, 52.8) years old, and 24 males and 8 females in the BT group, aged 37.0 (30.0, 44.0) years old. Patients in group RT were conventionally conducted with knee joint stretch treatment, continuous passive motion treatment, lower limb muscle strength training and pressure therapy; while patients in group BT were conducted with balance training besides RT such as sitting balance, center of gravity transfer, pelvic stability, standing alternately on one leg and standing on balance pad. Patients in the 2 groups were treated for 4 months. Before treatment and after 4 months of treatment,Berg balance score, lower limb function score and balance activity self-confidence score were evaluated . The data were statistically analyzed with t test, Mann-Whitney U test, Wilcoxon signed rank test or χ² test. Results: (1) Before treatment, the difference value of Berg balance score of patients in group RT was (25±9), which was similar to (25±7) in group BT(t=-0.154,P>0.05). After 4 months of treatment, the difference value of Berg balance score of patients in group BT was (43±6), which was higher than (40±6) in group RT (t=2.028,P<0.05). The difference values of Berg balance scores of the patients in group RT and BT after 4 months of treatment were obviously higher than those before treatment(t=-15.189,-26.2,P<0.001). (2) Before treatment, the lower limb function score of patients in group RT was 25.0 (16.5,30.0), which was similar to 23.0(10.3,28.8) in group BT(Z=-1.575,P>0.05). After 4 months of treatment, the lower limb function score of patients in group BT was 55.0(35.0, 60.0) , which was significantly higher than 43.0 (36.0, 53.0) in group RT(Z=-2.744,P<0.01). The lower limb function scale of patients in group RT and BT after 4 months of treatment were obviously higher than those before treatment(Z=-4.943,-4.955,P<0.01). (3) Before treatment, the balance activity self-confidence scores of the two groups were similar(t=-0.966,P>0.05) . After 4 months of treatment , the balance activity self-confidence scores of patients in group ST was significantly higher than that in group RT (t=3.343,P<0.01). The balance activity self-confidence scores of patients in groups RT and BT after 4 months of treatment were obviously higher than those before treatment(t=-19.611,-34.300,P<0.001). Conclusions: The balance training can effectively promote the recovery of lower limb motor and balance function on the basis of conventional rehabilitation treatment for patients with lower limb motor and balance dysfunction after deep burns.