Diabetes MellitusPathfeelNCT06855420
Smart Insoles for Improving Sensation, Balance and Mobility in People With Diabetic Peripheral Neuropathy.
A study testing Vibration on and Vibration off in people with Diabetes Mellitus and Diabetic Neuropathies, run by Walk With Path at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diabetes Mellitus, Diabetic Neuropathies, Unsteadiness
- What is being tested?
- Vibration on and Vibration off
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2022to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester Metropolitan University
Manchester, M15GD
About this study
Official title: Investigating the Efficacy of Foot Sole Vibration on Balance and Physical Activity in People With Diabetic Peripheral Neuropathy.
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.
Read the 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
- Being tested
- Vibration on, Vibration off
- Keywords
- smart wearable device, vibration, insoles, gait, peripheral sensation, balance
- Medical subject headings
- Diabetes Mellitus, Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibration onDevice
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 offDevice
Participants will wear the device with vibration turned off for at least 4 hours per day during 10 days of intervention.
| Study group | Role | What they receive |
|---|---|---|
| Vibration | Active comparator | Insoles with vibration Receives: Device: Vibration on |
| No Vibration | Placebo comparator | Insoles without vibration Receives: Device: Vibration off |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural Balance
Centre-of-pressure velocity will be assessed using a force platform.
Measured: 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.
Measured: 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
Vibration perception threshold (VPT) at the hallux will be measured bilaterally by a neurothesiometer.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start1 Oct 2022
- Primary completion1 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walk With Path
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Manchester Metropolitan University
- Responsible party
- Sponsor
- Investigators
- Neil D. Reeves, PhD, Professor, Principal investigator, Lancaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06855420
- Sponsor's protocol ID
- 46201
- Acronym
- Pathfeel
- Status last verified
- Feb 2025
- First submitted
- 25 Nov 2024
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
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.
PubMed 38536962
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Efficacy of Foot Sole Vibration on Balance and Physical Activity in People With Diabetic Peripheral Neuropathy.
- ClinicalTrials.gov ID
- NCT06855420
- Acronym / sponsor ID
- Pathfeel / 46201
- Conditions
- Diabetes Mellitus, Diabetic Neuropathies, Unsteadiness
- Keywords
- smart wearable device, vibration, insoles, gait, peripheral sensation, balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Walk With PathIndustry (pharma, biotech, devices)
- Collaborators
- Manchester Metropolitan University
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vibration | Active comparator | Device: Vibration onInsoles with vibration |
| No Vibration | Placebo comparator | Device: Vibration offInsoles without vibration |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibration onSole 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 |
| Vibration offParticipants will wear the device with vibration turned off for at least 4 hours per day during 10 days of intervention. | Device | No Vibration |
Primary outcome
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.
Centre-of-pressure velocity will be assessed using a force platform.
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.
Gait speed during level and stair walking will be assessed by 3D Motion Capture system.
2 secondary outcomes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Results publication: PubMed 38536962Orlando 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.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil D. Reeves, PhD, Professor principal investigator
Lancaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibration on and Vibration off in people with Diabetes Mellitus and Diabetic Neuropathies, run by Walk With Path at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06855420, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.