Skip to main content
OpenTrials
Completed

NCT Number: NCT06292468

Plantar Cutaneous Sensory Stimulation 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetic Neuropathies Diabetes Complications Diabetes Mellitus Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

45 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PhysioFit, Faisalabad, Punjab Province, Pakistan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Traditional Physical therapy

Other

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.

Plantar cutaneous sensory stimulation

Other

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.

Primary outcomes

  1. 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

  2. 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

  3. Spatiotemporal gait parameters

    Time frame: 6th week

    By using a stopwatch and measuring tape

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 5, 2024
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.