Smart Insoles for Improving Sensation, Balance and Mobility in People with Diabetic Peripheral Neuropathy.

NCT06855420 | Completed

• 1 other identifier: 46201
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Diabetic Neuropathies; Unsteadiness

Keywords

smart wearable device; vibration; insoles; gait; peripheral sensation; balance

Outcome Measures

Primary Outcomes (2)

• Postural Balance

  Centre-of-pressure velocity will be assessed using a force platform.

  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.

• Gait speed during walking

  Gait speed during level and stair walking will be assessed by 3D Motion Capture system.

  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 (2)

• Peripheral Sensation

  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.

• Peripheral Sensation 2

  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.

Study Arms (2)

Vibration

ACTIVE COMPARATOR

Insoles with vibration

Device: Vibration on

No Vibration

PLACEBO COMPARATOR

Insoles without vibration

Device: Vibration off

Interventions

Vibration on DEVICE

Sole vibration will be applied by a vibrating insole system for 10 days. Participants will wear the device for at least 4 hours per day.

Vibration

Vibration off DEVICE

Participants will wear the device with vibration turned off for at least 4 hours per day during 10 days of intervention.

No Vibration

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Walk With Path: lead
• Manchester Metropolitan University: collaborator

Study Sites (1)

Manchester Metropolitan University

Manchester, M15GD, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 38536962 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications

Study Officials

• Neil D. Reeves, PhD, Professor

  Lancaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: March 3, 2025
• Study Start: October 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: November 30, 2023
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)