Balance4Mobility: Effects of Walkasins Use on Clinical Outcomes of Gait and Balance Function in Individuals With Peripheral Neuropathy and Balance Problems - A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 10
- 主要终点
- Functional Gait Assessment (FGA)
研究概览
简要总结
The goal of this clinical trial is to is to test whether Walkasins can help people with peripheral neuropathy maintain their balance better. The main question it aims to answer is whether participants who use Walkasins on an everyday basis over a six-month period will report better awareness of their foot placement on the ground.
Researchers will compare Walkasins users to a control group of participants who are not using Walkasins to see if the device improves the users' performance on some standing and walking tests. Control group participants will get Walkasins after six months of being in the study.
During the study participants will be asked to do the following:
- Answer questions about their medical history and balance.
- Do some standing and walking tests. Some of the tests will be timed.
- Attend study visits and participate in study phone calls.
- Keep track of any falls and notify study staff if they fall.
- Wear the Walkasins device on a regular basis.
详细描述
A randomized cross-over study of short-term, in-clinic effects of Walkasins use, conducted at the Minneapolis Veterans Affairs Medical Center (VAMC) and published in PLOS ONE, found clinically meaningful and statistically significant improvements in gait speed and functional balance in patients with SPN using Walkasins. The authors stated that "findings suggest new sensory balance cues provided to the lower limb can modulate the activity of relevant nerve afferents and become integrated into sensorimotor control of balance and gait."
In 2020 a multi-site clinical trial of the long-term effects of daily Walkasins use (walk2Wellness, ClinicalTrials.gov #NCT03538756) was published in Frontiers in Aging Neuroscience. After 10 weeks of Walkasins use, this long-term study demonstrated clinically meaningful improvements in Functional Gait Assessment (FGA) and gait speed, which is associated with a lower fall risk. The authors concluded that "a wearable sensory prosthesis may provide a new way to treat gait and balance problems and manage falls in high fall-risk patients with PN."
Most recently, an analysis of data from 26 weeks of Walkasins use in the walk2Wellness trial showed that "participants who reported falls over 6 months prior to the study had a 43% decrease in fall rate during the study as compared to self-report 6-month pre-study (11.8 vs. 6.7 falls/1000 patient days, respectively, p <0.004), similar to the 46% decrease reported after 10 weeks of use."
The present study involves an assessment of Walkasins through a randomized, controlled trial with a primary endpoint of 26 weeks. Furthermore, this study will enroll only individuals 55 and older with a goal of including participants that reflect the Medicare population to support payer reimbursement for Walkasins.
The objectives of this study are as follows:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand and provide informed consent for him or herself
- •Age 55 and older, male or female
- •Able to complete all functional outcome measures without the use of an assistive device
- •Clinical diagnosis of peripheral neuropathy prior to participating in the study as documented in the participant's medical record or by physician's note. Individuals with chemo-induced peripheral neuropathy must be at least one-year post-chemotherapy, indicating that their PN has become a chronic condition.
- •Self-reported gait and balance problems
- •Foot size that allows the Walkasins to function appropriately
- •Willing to use the Walkasins device as recommended
排除标准
- •Ability to stand on one leg for at least 30 seconds (If the person can stand for at least 30 seconds, he/she is excluded because his/her balance is likely not impaired enough to benefit from Walkasins.)
- •Self-reported acute thrombophlebitis, including deep vein thrombosis
- •Self-reported severe peripheral vascular disease
- •Untreated lymphedema
- •Untreated lesion of any kind, swelling, infection, inflamed area of skin or eruptions on the lower leg near product use
- •Self-reported, untreated fractures in the foot and ankle
- •Other neurological or musculoskeletal conditions that moderately or severely impact walking
- •Use of ankle-foot orthosis for ambulation that prevents donning of Walkasins
- •Weight of more than 300 pounds
- •Inability to perceive vibration from Walkasins Haptic Module
研究组 & 干预措施
Walkasins User Group
Participants randomized to the user group will receive Walkasins, consisting of two parts for each leg: the Haptic Module and the Receptor Sole. They will use the device for one year (52 weeks). In addition, the user group participants will receive the fall prevention information provided to the control group.
干预措施: Fall Prevention Training (Other)
Control Group
Participants randomized to the control group will receive fall prevention information during the baseline visit. After six months, they will receive Walkasins for use during the final six months of the trial.
干预措施: Fall Prevention Training (Other)
Walkasins User Group
Participants randomized to the user group will receive Walkasins, consisting of two parts for each leg: the Haptic Module and the Receptor Sole. They will use the device for one year (52 weeks). In addition, the user group participants will receive the fall prevention information provided to the control group.
干预措施: Walkasins (Device)
结局指标
主要结局
Functional Gait Assessment (FGA)
时间窗: Baseline, Week 10, Week 26, Week 36 (Control Group), and Week 52
The Functional Gait Assessment (FGA) is a 10-item scale that measures postural stability while individuals perform walking tasks that are scored from 0 to 3 (3 = normal, 2 = mild impairment, 1 = moderate impairment, 0 = severe impairment). Scores range from a minimum of 0 to a maximum of 30. Higher scores indicate better postural stability.
Patient-Specific Functional Scale (PSFS)
时间窗: Baseline, Week 5, Week 10, Week 18, Week 26, Week 31, Week 36, Week 41, Week 46, and Week 52
The PSFS asks patients to define up to five specific tasks that they have difficulty with or are unable to perform because of their physical injury or disability. Some research studies adapt the PSFS by asking participants to list three tasks rather than five, which is the plan for this study. The patients then rate their difficulty in performing those tasks on a scale of 0 to 10 with 0 meaning "unable to perform activity" to 10 meaning "able to perform activity at the same level as before injury or problem." The ratings for the three activities are averaged. Higher scores indicate greater ability to perform the activity.
PROMIS® PROWalk
时间窗: Baseline, Week 5, Week 10, Week 18, Week 26, Week 31, Week 36, Week 41, Week 46, and Week 52
Eight items that have the most relevance for measuring change in individuals who have received Walkasins were selected from the 165 items comprising the PROMIS Item Bank v2.0 - Physical Function. Specifically, the selected items measure an individual's ability to perform various activities that involve upright mobility (balance, standing, and walking). Participants rate the eight items on a scale of 1 to 5; the raw scores are converted to T-scores for comparison to national norms.
次要结局
- 10-Meter Walk Test(Baseline, Week 10, Week 26, Week 36 (Control Group), and Week 52)
- Four-Stage Balance Test(Baseline, Week 10, Week 26, Week 36 (Control Group), and Week 52)
- Modified Multidirectional Reach Test(Baseline, Week 10, Week 26, Week 36 (Control Group), Week 52)
- Single Leg Stance Test(Baseline, Week 26)
- Timed Up and Go (TUG) and Timed Up and Go Cognitive/Dual Task (TUG-COG)(Baseline, Week 10, Week 26, Week 36 (Control Group), Week 52)
- Activities-specific Balance Confidence Scale 6 (ABC-6)(Baseline, Week 5, Week 10, Week 18, Week 26, Week 31, Week 36, Week 41, Week 46, and Week 52)
- EuroQol HRQoL (EQ-5D-5L)(Baseline, Week 10, Week 26, Week 36, and Week 52)
- PROMIS® Scale v2.0 - Pain Intensity 3a and Neuropathic Foot Pain Rating(Baseline, Week 10, Week 26, Week 36, Week 52)
- Rapid Assessment of Physical Activity (RAPA) and Telephone Assessment of Physical Activity (TAPA)(Baseline, Week 10, Week 18, Week 26, Week 36, and Week 52)
- Walkasins Experience Survey(Baseline, Week 10, Week 26, Week 36 (Control Group), and Week 52)
- 10-Meter Walk Test(Baseline, Week 10, Week 26, Week 36 (Control Group), and Week 52)
- Four-Stage Balance Test(Baseline, Week 10, Week 26, Week 36 (Control Group), and Week 52)
- Modified Multidirectional Reach Test(Baseline, Week 10, Week 26, Week 36 (Control Group), Week 52)
- Single Leg Stance Test(Baseline, Week 26)
- Timed Up and Go (TUG) and Timed Up and Go Cognitive/Dual Task (TUG-COG)(Baseline, Week 10, Week 26, Week 36 (Control Group), Week 52)
- Activities-specific Balance Confidence Scale 6 (ABC-6)(Baseline, Week 5, Week 10, Week 18, Week 26, Week 31, Week 36, Week 41, Week 46, and Week 52)
- EuroQol HRQoL (EQ-5D-5L)(Baseline, Week 10, Week 26, Week 36, and Week 52)
- PROMIS® Scale v2.0 - Pain Intensity 3a and Neuropathic Foot Pain Rating(Baseline, Week 10, Week 26, Week 36, Week 52)
- Rapid Assessment of Physical Activity (RAPA) and Telephone Assessment of Physical Activity (TAPA)(Baseline, Week 10, Week 18, Week 26, Week 36, and Week 52)
- Walkasins Experience Survey(Baseline, Week 10, Week 26, Week 36 (Control Group), and Week 52)