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Plantar Cutaneous Sensory Stimulation in Patients With Diabetic Neuropathy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06292468
Enrollment
50
Registered
2024-03-05
Start date
2023-07-07
Completion date
2023-09-18
Last updated
2024-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Neuropathies

Keywords

Diabetic neuropathy, Gait parameters, Plantar cutaneous stimulation, Postural instability

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.

Interventions

OTHERTraditional 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.

OTHERPlantar 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.

Sponsors

Riphah International University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
45 Years to 67 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Foot tactile sensitivity6th weekSemmes 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 control6th weekBrief 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 parameters6th weekBy using a stopwatch and measuring tape

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026