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New treatment option for Peripheral Neuropathy With Type 2 Diabetes
Official title Wearable Sensory Prosthesis to Improve Coordination, Walking, and Physical Activity
ClinicalTrials.gov ID: NCT07554443
What this study is testing
- What it's testing
- The goal of this clinical trial is to investigate whether sensory stimulations from a neuroprosthesis device (Walkasins®) can increase physical activity and improve gait quality in persons with peripheral neuropathy (PN). The main question it aims to answer is whether Walkasins enhances habitual activity patterns in adults with peripheral neuropathy.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- Be 60 years of age or older
- Have a diagnosis of PN with plantar sensory loss
- Demonstrate balance impairment, defined as a Single-Leg Stance time of \<23 seconds
- Be able to walk independently for at least 6 minutes without the use of an assistive device (rest breaks permitted)
- Be willing to use the Walkasins device as recommended
You likely can't join if
- Under 60 years old
- Do not have a diagnosis of PN with plantar sensory loss
- 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
See the full eligibility criteria
- Be 60 years of age or older
- Have a diagnosis of PN with plantar sensory loss
- Demonstrate balance impairment, defined as a Single-Leg Stance time of \<23 seconds
- Be able to walk independently for at least 6 minutes without the use of an assistive device (rest breaks permitted)
- Be willing to use the Walkasins device as recommended
- Be willing to participate in all aspects of physical activity monitoring and study assessments
- Under 60 years old
- Do not have a diagnosis of PN with plantar sensory loss
- 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
- Do not demonstrate balance impairments, defined as a Single-Leg Stance time of \<23 seconds
The study team makes the final eligibility decision.
Where it's taking place
- Jacksonville, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jacksonville, Florida, 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.