Effects of Plantar Cutaneous Sensory Stimulation on Foot Tactile Sensitivity, Postural Control, and Spatiotemporal Gait Parameters in Patients With Diabetic Neuropathy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 50
- Locations
- 4
- Primary Endpoint
- Foot tactile sensitivity
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 45 Years to 67 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Secondary Outcomes
No secondary outcomes reported