NCT06855420

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

Investigating the Efficacy of Foot Sole Vibration on Balance and Physical Activity in People With Diabetic Peripheral Neuropathy.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Walk With Path · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2022-10-01
• Primary completion: 2023-11-01
• Completion: 2023-11-30
• First posted: 2025-03-03
• Last updated: 2025-03-03

Locations

1 site across 1 country: United Kingdom