Long-term Effects of Using a Novel Orthotic Insole for Tactile Stimulation in Diabetic Peripheral Neuropathy and Follow-up

NCT06688708 | Completed DMC

• 1 other identifier: SWUEC-661032
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

• Quantitative data will be presented with median (mean) and standard deviation (SD).
• Qualitative data will be presented with numbers and percentages.
• An independent t-test will be used to compare the independent outcomes.
• A paired t-test will be used to compare the dependent outcomes.
• A repeated-measures ANCOVA will be used for between group comparisons.
• A repeated-measures ANOVA will be used for within-group comparison.
• MANCOVA will be used for analyzing the covariates' effect on the relationship between the independent grouping variables and the continuous dependent variables.
• Cohen's d will be used to determine the effect sizes.
• Ethical Consideration (1) All participants were provided with detailed project information prior to participation in the research project.
• Using the novel VFO may lead to efficient treatment for neurorehabilitation in DPN.
• The investigators hope that this low-cost VFO can offer advantages such as affordability, widespread use, and home-based applications.
• The benefits of using the novel VFO that can improve tactile sensation on the plantar surface of the foot in diabetic peripheral neuropathy.
• Employing the novel VFO can reduce VPT.
• Using the novel VFO can help prevent diabetic foot ulceration (DFU), lessen a risk of DFU recurrence, and avoid lower limb amputation.
• Applying the novel VFO may help restore and prolong tactile sensation.
• Using the novel VFO may aid in slowing DPN deterioration and decreasing peripheral nervous system impairment.
• Utilizing the VFO may help improve quality of life for DPN people.
• Payment was provided for those participants who attend throughout the study.
• All participants received a custom-made foot orthosis after completing the study.

Conditions

Diabetic Peripheral Neuropathy Type 2

Keywords

Diabetic Peripheral Neuropathy; Noise; Orthosis; Stochastic Resonance; Tactile; Vibration

Outcome Measures

Primary Outcomes (1)

• Vibration Perception Threshold (VPT)

  Vibration perception threshold (VPT) is the lowest vibrational intensity required to perceive a vibration stimulus, and VPT is known to be impaired at an early stage in various neuropathies. VPT is critical in detecting diabetic peripheral neuropathy early; as a result, VPT is relevant to the risk of diabetic foot ulceration (DFU). Thus, VPT is an effective predictor of the risk of DFU and it could be used to target DFU for early detection and treatment.

  Immediate assessment after finish intervention

Study Arms (2)

Use vibrating foot orthosis with tactile stimulation

EXPERIMENTAL

32 participants were assigned to use a vibrating foot orthosis (VFO) with tactile stimulation (using the VFO combined with a random 0-100 Hz square wave pulse stimulus with pseudorandom white noise via a stochastic resonance approach) at home for 30 days. Participants had to conduct intervention for 60 minutes a day. 90% VPT of each participant was chosen as the subthreshold stimulation level for tactile stimulation. Posttests were given by three consecutive appointments on the 1st day, the 15th day, and the 30th day. Participants had to meet a prosthetist and orthotist (PO) at the experimental site on the three consecutive appointments for posttest evaluation. After completing this intervention, participants were followed up the VPT level by evaluation every 7 days.

Device: Using vibrating foot orthosis with tactile stimulation

Use vibrating foot orthosis without tactile stimulation

SHAM COMPARATOR

32 participants were assigned to use the VFO without tactile stimulation (using the VFO with only vibration 100 Hz frequency ) at home for 30 days. Participants were blinded. Even though there was no tactile stimulation, the device still performed vibration. Posttests were given by three consecutive appointments on the 1st day, the 15th day, and the 30th day. Participants had to meet a PO at the experimental site on the three consecutive appointments for posttest evaluation. Noted, there was no follow-up after completing this intervention.

Device: Using vibrating foot orthosis without tactile stimulation

Interventions

Using vibrating foot orthosis with tactile stimulation DEVICE

Stimulating tactile sensation by using vibrating foot orthosis in conjunction with a random 0-100 Hz square wave pulse stimulus and pseudorandom white noise via a stochastic resonance approach.

Also known as: Using vibrating foot orthosis in conjunction with a random 0-100 Hz square wave pulse stimulus and pseudorandom white noise via a stochastic resonance approach

Use vibrating foot orthosis with tactile stimulation

Using vibrating foot orthosis without tactile stimulation DEVICE

Stimulating tactile sensation by using vibrating foot orthosis with only vibration 100 Hz freqency.

Also known as: Using vibrating foot orthosis with only vibration 100 Hz freqency

Use vibrating foot orthosis without tactile stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes mellitus and peripheral neuropathy diagnosis
• Absence of foot problems such as ulcers, calluses, skin problems, etc.
• No muscle weakness
• Stability in neurological and vital signs
• Adequate cognitive and language skills to follow instructions
• Ability to sense vibration
• Ability to sit for at least 60 minutes

You may not qualify if:

• Musculoskeletal problem that makes it difficult to use vibrating foot orthosis, such as severe pain or joint contracture in any foot joints
• Mental disorders
• Hypersensitivity to material substances in vibrating foot orthosis

Sponsors & Collaborators

• Srinakharinwirot University: lead

Study Sites (1)

Srinakharinwirot University

Ongkharak, Changwat Nakhon Nayok, 26120, Thailand

Location

Study Officials

• Natapatchakrid Thimabut, Ph.D.

  Srinakharinwirot University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Allocation concealment Participants and Investigators were blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Intervention 1: Use vibrating foot orthosis with tactile stimulation Intervention 2: Use vibrating foot orthosis without tactile stimulation

Study Record Dates

• First Submitted: November 8, 2024
• First Posted: November 14, 2024
• Study Start: June 12, 2023
• Primary Completion: November 30, 2023
• Study Completion: December 29, 2023
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: IPD and documents will be available for sharing 1 year and after publication for a period of 2 years.

Locations

TH (1)