Clinical trial NCT06855420: Smart Insoles for Improving Sensation, Balance and Mobility in People with Diabetic Peripheral Neuropathy.
Official title: Investigating the Efficacy of Foot Sole Vibration on Balance and Physical Activity in People with Diabetic Peripheral Neuropathy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Diabetic Neuropathies
Unsteadiness
Keywords: smart wearable device
vibration
insoles
gait
peripheral sensation
balance
Lead sponsor: Walk With Path
Sponsor class: INDUSTRY
Collaborators: name: Manchester Metropolitan University
First posted: 2025-03-03
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The long-term effects of vibrating insoles on improving gait, balance and peripheral sensation in people with diabetic peripheral neuropathy remain unknown. The Pathfeel Clinical Trial will investigate the efficacy of vibratory insoles worn for ten days for enhancing sensory perception, gait quality, balance and physical activity in people with mild to severe diabetic neuropathy. The primary outcome will be changes in gait speed and postural and dynamic balance.

Detailed description: The Path Feel Clinical Trial will investigate the efficacy of foot sole vibration applied for 10 days during daily life for improving peripheral sensation, balance and mobility in people with diabetic peripheral neuropathy.

Twenty-two people with mild to severe diabetic neuropathy will perform a prospective comparison where they wear an insole system over the course of two interventional periods of 10 days each in a randomised, cross-over design, during which there will be a period where the device provides vibrational stimuli, vs a control condition where the device is worn, but provides no stimuli. Any changes in activity levels, peripheral sensation, quality of life and balance control will be compared between each condition to determine the longer-term effects of foot sole vibration.

Each participant will undertake four study visits with periods of device use between them. Participants will complete a set of questionnaires that will assess quality of life (NeuroQoL) and fear of falling (FES-I). Measurements of the level of peripheral neuropathy will be taken at both feet using non-invasive methods, including a neurothesiometer (i.e., Vibration Perception Threshold) and a composite score (i.e., modified Neuropathy Disability Score). Gait, postural and dynamic balance during daily activities, including walking, stair walking will be assessed through a combination of 3D Motion Capture system and force platforms. Changes in physical activity will be quantified by accelerometry.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of diabetes type 1 or 2
* ≥1 palpable foot pulses
* Presence of mild to moderate diabetic peripheral neuropathy defined by a vibration perception threshold ≥15 Volts and/or mNDS score ≥3.
* Aged ≥ 18 years
* Ability to walk unaided for 30 steps
* Able to understand the study requirements
* Ability to check their feet regularly (or have another person check).
* Able to read the study documents
* Fit shoe size EU 36-47.5 / UK 3.5-13.

Exclusion Criteria:

• Active foot ulcer

* Lower limb amputation (anything more than amputation of two lesser toes)
* Presence of Charcot deformity
* Dementia or other cognitive impairment
* Significant cardiopulmonary or other systemic disease limiting the patient's ability to walk 30 steps.
* Person's with bodyweight greater than 130kg (due to insole device limitations)
* Presence of implantable neurostimulators
* Presence of a pacemaker.

Primary outcomes:
measure: Postural Balance
timeFrame: Measurements were taken at four time points: at baseline, after 10 days of the first vibratory intervention, after a 10-day washout period, and at the end of the 10-day second vibratory intervention.
measure: Gait speed during walking
timeFrame: Measurements were taken at four time points: at baseline, after 10 days of the first vibratory intervention, after a 10-day washout period, and at the end of the 10-day second vibratory intervention.
Secondary outcomes:
measure: Peripheral Sensation
timeFrame: Measurements were taken at four time points: at baseline, after 10 days of the first vibratory intervention, after a 10-day washout period, and at the end of the 10-day second vibratory intervention.
measure: Peripheral Sensation 2
timeFrame: Measurements were taken at four time points: at baseline, after 10 days of the first vibratory intervention, after a 10-day washout period, and at the end of the 10-day second vibratory intervention.
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester Metropolitan University
Study officials:
affiliation: Lancaster University
name: Neil D. Reeves, PhD, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Orlando G, Brown S, Jude E, Bowling FL, Boulton AJM, Reeves ND. Acute Effects of Vibrating Insoles on Dynamic Balance and Gait Quality in Individuals With Diabetic Peripheral Neuropathy: A Randomized Crossover Study. Diabetes Care. 2024 Jun 1;47(6):1004-1011. doi: 10.2337/dc23-1858.