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

NCT ID: NCT06855420

Last Updated: 2025-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2023-11-30

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.

Conditions

Diabetes Mellitus; Diabetic Neuropathies; Unsteadiness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Vibration

Insoles with vibration

Group Type: ACTIVE_COMPARATOR

Vibration on

Intervention Type: 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.

No Vibration

Insoles without vibration

Group Type: PLACEBO_COMPARATOR

Vibration off

Intervention Type: DEVICE

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

Interventions

Vibration on

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.

Intervention Type: DEVICE

Vibration off

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Manchester Metropolitan University

OTHER

Sponsor Role: collaborator

Walk With Path

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neil D. Reeves, PhD, Professor

Role: PRINCIPAL_INVESTIGATOR

Lancaster University

Locations

Manchester Metropolitan University

Manchester, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 38536962 (View on PubMed)

Other Identifiers

46201

Identifier Type: -

Identifier Source: org_study_id