Smart Insoles for Improving Sensation, Balance and Mobility in People with Diabetic Peripheral Neuropathy. (Pathfeel)
Investigating the Efficacy of Foot Sole Vibration on Balance and Physical Activity in People with Diabetic Peripheral Neuropathy.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Manchester, United Kingdom, M15GD
- Manchester Metropolitan University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Vibration
Insoles with vibration
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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.
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Placebo Comparator: No Vibration
Insoles without vibration
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Participants will wear the device with vibration turned off for at least 4 hours per day during 10 days of intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postural Balance
Time Frame: 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.
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Centre-of-pressure velocity will be assessed using a force platform.
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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.
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Gait speed during walking
Time Frame: 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.
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Gait speed during level and stair walking will be assessed by 3D Motion Capture system.
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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.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peripheral Sensation
Time Frame: 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.
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Vibration perception threshold (VPT) at the hallux will be measured bilaterally by a neurothesiometer.
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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.
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Peripheral Sensation 2
Time Frame: 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.
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Large and small sensory nerve function will be assessed using the modified Neuropathy Disability Score (mNDS), a composite scoring tool ranging from 0 to 10 points.
Higher scores indicate a greater decline in sensation.
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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.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Neil D. Reeves, PhD, Professor, Lancaster University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 46201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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