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Plantar Cutaneous Sensory Stimulation in Patients With Diabetic Neuropathy

R

Riphah International University

Status

Completed

Conditions

Diabetic Neuropathies

Treatments

Other: Plantar cutaneous sensory stimulation
Other: Traditional physical therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT06292468
REC/RCR&AHS/23/0238

Details and patient eligibility

About

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

Enrollment

50 patients

Sex

All

Ages

45 to 67 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 2 patient groups

Traditional physical therapy
Active Comparator group
Description:
This group received conventional physical therapy protocol along with foot care guidelines.
Treatment:
Other: Traditional physical therapy
Plantar cutaneous sensory stimulation.
Experimental group
Description:
This group received plantar cutaneous sensory stimulation along with conventional physical therapy protocol and foot care guidelines.
Treatment:
Other: Plantar cutaneous sensory stimulation

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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