Plantar Cutaneous Sensory Stimulation in Patients With Diabetic Neuropathy

March 4, 2024 updated by: Riphah International University

Effects of Plantar Cutaneous Sensory Stimulation on Foot Tactile Sensitivity, Postural Control, and Spatiotemporal Gait Parameters in Patients With Diabetic Neuropathy

To determine the effects of plantar cutaneous sensory stimulation on foot tactile sensitivity, postural control, and spatiotemporal gait parameters in patients with diabetic neuropathy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Faisalabad, Punjab, Pakistan, 38000
        • PhysioFit
      • Faisalābad, Punjab, Pakistan, 38000
        • Allied Hospital Faisalabad.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ranged between 45-67 years.
  • Both male and female genders are included.
  • DM for the past 7 years.
  • Scored > 2/13 on the Michigan Neuropathy Screening Instrument (MNSI) questionnaire including at least two DPN symptoms.
  • Scored >1/10 on MNSI physical assessment including impaired vibration perception

Exclusion Criteria:

  • Loss of protective foot sensation (defined as a lack of response to the monofilament of the sensory evaluation instrument).
  • Comorbidities include visual impairment, cerebrovascular accident, orthopedic trauma, labyrinthitis, peripheral vascular disease, and heart failure.
  • Foot ulcers, orthopedic or surgical problems in a lower limb, other neurological impairment.
  • Use of assistive devices for ambulation.
  • Inability to walk independently with or without an assistive device.
  • Receiving any structured supervised physiotherapy intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Traditional physical therapy
This group received conventional physical therapy protocol along with foot care guidelines.
Other: Traditional physical therapy
This group received 30 minutes of muscle stretching (quadriceps, gastrocnemius, hamstrings, tibialis), bilateral ankle strengthening, gait training and foot care guidelines, 3 times a week for a duration of six weeks.
Experimental: Plantar cutaneous sensory stimulation.
This group received plantar cutaneous sensory stimulation along with conventional physical therapy protocol and foot care guidelines.
Other: Plantar cutaneous sensory stimulation
This group received 45 minutes of plantar cutaneous sensory stimulation, TENS, muscle stretching (quadriceps, gastrocnemius, hamstrings, tibialis), bilateral ankle strengthening, gait training, and foot care guidelines, 3 times a week for a duration of six weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Foot tactile sensitivity
Time Frame: 6th week
Semmes Weinstein monofilaments, Foot tactile sensitivity loss, commonly assessed by monofilaments, is a fall risk factor among older adults. The broadly used threshold of the monofilament for fall risk assessment in older adults is 5.07
6th week
Postural control
Time Frame: 6th week
Brief BESTest is a clinical balance assessment tool. It is an abbreviated version of Balance Evaluation Systems Test (BESTest) designed to assess 6 different aspects contributing to postural control in standing and walking. It consist of 27 tasks, with 36 items in total. Each items is scored based on ordinal scale scoring from 0- 3 where 3 representing best performances and 0 representing worst performances. Scores for the total test is provided as a percentage of total points i.e. 108. In addition, 6 sub-systems scores can be generated separately in percentage of total score each representing a specific balance system
6th week
Spatiotemporal gait parameters
Time Frame: 6th week
By using a stopwatch and measuring tape
6th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Binash Afzal, PHD*, Riphah International University Lahore Campus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2023

Primary Completion (Actual)

August 18, 2023

Study Completion (Actual)

September 18, 2023

Study Registration Dates

First Submitted

January 28, 2024

First Submitted That Met QC Criteria

March 4, 2024

First Posted (Estimated)

March 5, 2024

Study Record Updates

Last Update Posted (Estimated)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR&AHS/23/0238

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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