Skip to main content
Clinical Trials/NCT06292468
NCT06292468
Completed
N/A

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

Riphah International University2 sites in 1 country50 target enrollmentJuly 7, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Diabetic Neuropathies
Sponsor
Riphah International University
Enrollment
50
Locations
2
Primary Endpoint
Foot tactile sensitivity
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
July 7, 2023
End Date
September 18, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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

Spatiotemporal gait parameters

Time Frame: 6th week

By using a stopwatch and measuring tape

Study Sites (2)

Loading locations...

Similar Trials