No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
55 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
200 (estimated)
Sponsor
RxFunction Inc. · Industry
Who this trial is looking for
This trial is looking for people aged 55 and older who have balance problems due to peripheral neuropathy. Participants will wear a device called Walkasins for six months and complete some tests to see if it helps them maintain their balance better.
Are You a Good Fit for This Trial?
You may be able to join if
I am 55 years old or older.
I have been diagnosed with peripheral neuropathy.
I can complete tests without using a walking aid.
I have problems with my balance and walking.
I can understand and agree to take part in this study.
I have foot size that works with Walkasins.
I am willing to use the Walkasins device as instructed.
I am at least one year post-chemotherapy if I have chemo-induced neuropathy.
You may not be able to join if
I can stand on one leg for at least 30 seconds.
I have self-reported acute thrombophlebitis or deep vein thrombosis.
I have self-reported severe peripheral vascular disease.
I have untreated lymphedema.
I have untreated wounds, infections, or swelling on my lower leg.
I have untreated fractures in my foot or ankle.
I have other neurological or musculoskeletal issues that severely affect my walking.
I weigh more than 300 pounds.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 part…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 …
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
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