Biofeedback Retention in Individuals With AKA

NCT05126485 | Unknown Early Phase 1

• 1 other identifier: W81XWH2110866
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief Summary

More than two million Americans are currently living with a full or partial limb loss, and an additional 185,000 amputations occur each year. The majority of amputations occur in the lower limbs. There are many potential causes for amputation, but the majority can be attributed to vascular diseases, such as diabetes, traumatic injury, and cancer. For these individuals, prosthetic devices play an important role in restoring mobility and enabling them to participate in everyday activities. However, when learning to use these devices, patients often alter their movement patterns to compensate for pain or discomfort, a decreased ability to feel what their prosthetic limb is doing, and/or a fear of falling. By changing their movement patterns, patients will tend to am their intact leg, which has been shown to lead to long-term joint damage and chronic injury. For perspective, 75% of United States veterans living with amputation are diagnosed with a subsequent disease affecting their muscle, bone, and/or joint health. Therefore, therapy sessions, known as gait retraining, are an integral part of teaching prosthesis users to walk in a safe and efficient manner. With recent advances in wearable technology, researchers and therapists have begun exploring the use of biofeedback systems to assist with this retraining. In these systems, wearable sensors are used to measure how the patient is moving in real-time, and can provide information on how much time they spend on each leg and how much each joint moves during walking. Biofeedback refers to the process of communicating the information from these sensors back to the patients instruct them whether they need to change their movements. Previous research has shown that these systems have excellent potential for helping patients with physical disabilities improve their quality of motion. However, relatively little research has explored how well individuals with above-knee leg amputations respond to biofeedback during gait retraining. Importantly, the question of whether the new movement patterns taught using biofeedback will persist after training has finished remains unanswered. Therefore, the primary objective of this research is to determine whether biofeedback is a feasible tool for gait retraining with above-knee prosthesis (including a prosthetic knee, ankle, and foot) users. To answer these questions, forty individuals currently using above-knee prosthetic systems will undergo a single session of biofeedback training. Half of these populations will be from the civilian population, and half will be military veterans. During this training, the biofeedback system will apply short vibrations - similar to those generated by cellphones - to their skin every time that the patient reaches the desired degree of hip rotation during walking. Participants will be instructed to keep increasing their hip motion until they feel a vibration on every step. Before training, they will be instrumented with a wearable motion captures system, pressure sensors embedded in their shoes, and a wearable heart rate monitor. Using these devices, researchers will measure the participants' walking patterns without biofeedback determine their current ability. Once training is complete, their walking patterns will be measured again, first while using the biofeedback system, and then again fifteen minutes and thirty minutes after the biofeedback system has been removed. The data measured during these tests will enable researchers to calculate functional mobility scores that are used to evaluate the quality of a patient's walking, and then compare how these scores change before, during, and after biofeedback training. The knowledge gained through this research constitutes a critical step towards identifying optimal biofeedback strategies for maximizing patient mobility outcomes. The findings will be essential for the development of gait retraining protocols designed to reduce the incidence of chronic injury, and enable patients to achieve their full mobility potential. Building on these results, the next research phase will be to incorporate biofeedback training into a standard six-week gait retraining protocol to evaluate its long-term effectiveness as a rehabilitation tool. Unlike traditional gait retraining, which requires patients to visit clinics in-person for all sessions, the wearable, automated nature of biofeedback training will allow patients to continue gait training from home. This ability will enable patients to continue training activities between sessions, and ultimately may be able to substitute for some in-person visits. This potential for remote therapy has exciting implications for improved access to care for individuals living long distances from their rehabilitation providers, or those suffering from social anxiety, as well as during global health pandemics where in-person visits are difficult.

Conditions

Amputation of Knee; Back Pain; Osteo Arthritis Knee

Keywords

biofeedback; amputation; gait; osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Two-minute Walk Test (2MWT)

  This outcome is meant to evaluate the functional exercise capacity of the individuals as they walk over a hard, flat surface to cover as much distance as possible in the allotted time. Its results are highly correlated with the longer six-minute walk test and the level of gait deviation determined by the Gait Deviation Index, and therefore can provide a secondary metric for evaluating the level of gait deviations exhibited during walking.

  30 minutes

Secondary Outcomes (2)

• Gait Symmetry Indices (SIs)

  30 minutes

• Modified Gait Profile Score (mGPS)

  30 minutes

Study Arms (1)

Randomizing Control and Biofeedback Phases

EXPERIMENTAL

The gait training and data collection procedure is split into two phases: a control phase and a biofeedback phase. The order of these phases is randomized across participants to reduce the probability of systematic error due participants "warming-up" or fatiguing between trials. Each phase consists of a pre-test, gait retraining session, and one or more post-tests.

Device: Haptic Biofeedback from SageMotion Biofeedback System

Interventions

Haptic Biofeedback from SageMotion Biofeedback System DEVICE

Haptic biofeedback units ("vibrating motors") will be placed on individual body segments. The haptic biofeedback system will be configured to provide vibratory stimuli when a target minimum hip extension angle is reached during the loading response. The minimum threshold will be determined by the therapist based on the patient's current ability. Specifically, the system will target a 10-20% increase in extension angle from their current level, as identified by the therapist. A vibration stimulus will be first applied each time this minimum angle is achieved, and will continually increase in intensity in proportion to the degree with which the patient exceeds this minimum value. The stimuli will stop being applied when the extension angle drops back below the threshold. These intensity-modulated stimuli have been selected to encourage the patient to exceed the minimum threshold rather than stop extending when the stimulus is first applied

Randomizing Control and Biofeedback Phases

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral limb amputation occurring between the knee and hip joints
• Minimum of one-year post-amputation and should have at least three-months experience walking with their current prosthetic system.
• Classified as K2 and K3-level community ambulators will be included in the study.
• Able to walk a minimum of 25 minutes with minimal rest. For participants with vascular-related amputations, a doctor's note clearing them to participate in the study will be required.
• Able to understand and speak English.

You may not qualify if:

• Previous spinal cord injury, stroke, or traumatic brain injury.
• Major upper-limb loss, defined as an amputation occurring proximal to the wrist.
• Previous or current injury affecting the function of their intact limb (e.g. pelvic injury, osteoarthritis, etc.)
• Significant hip contracture exceeding 15°
• Body-mass-index exceeding 35

Sponsors & Collaborators

• San Jose State University: lead
• University of California, San Francisco: collaborator
• VA Palo Alto Health Care System: collaborator

Study Sites (2)

VA Palo Alto Healthcare System

Palo Alto, California, 94304, United States

RECRUITING

University of California San Francisco

San Francisco, California, 94143, United States

RECRUITING

MeSH Terms

Conditions

Back Pain; Osteoarthritis

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Matthew J Leineweber, Ph.D.

CONTACT

4089243931; matthew.leineweber@sjsu.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A single group of participants will undergo both traditional gait training and biofeedback-based gait training. Measurements will be taken before and after each training session. The order of training will be randomized.

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: November 19, 2021
• Study Start: September 15, 2021
• Primary Completion: September 14, 2024
• Study Completion: September 14, 2024
• Last Updated: October 2, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)