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

NCT06855420 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2025-03-03

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Manchester Metropolitan University

    collaborator OTHER

  • Walk With Path

    lead INDUSTRY

Principal Investigators

  • Neil D. Reeves, PhD, Professor · Lancaster University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2023-11-01
Completion
2023-11-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06855420 on ClinicalTrials.gov