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New treatment option for Peripheral Neuropathies
Official title Balance4Mobility: Effects of Walkasins Use in Individuals With Peripheral Neuropathy and Balance Problems
ClinicalTrials.gov ID: NCT06959277
What this study is testing
- What it's testing
- 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.
- Time commitment: about 6 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 and older
You may be able to join if
- 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...
- Self-reported gait and balance problems
You likely can't join if
- 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...
- 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
See the full eligibility 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...
- Self-reported gait and balance problems
- Foot size that allows the Walkasins to function appropriately
- Willing to use the Walkasins device as recommended
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Mesa, Arizona, United States
- Boston, Massachusetts, United States
- Saint Paul, Minnesota, United States
- Amherst, New York, United States
- Pittsburgh, Pennsylvania, United States
- Galveston, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mesa, Arizona, United States; Boston, Massachusetts, United States; Saint Paul, Minnesota, United States; Amherst, New York, United States; Pittsburgh, Pennsylvania, United States; Galveston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.