Plantar Cutaneous Sensory Stimulation in Patients With Diabetic Neuropathy

NCT06292468 | Completed

• 1 other identifier: REC/RCR&AHS/23/0238
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetic Neuropathies

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Foot tactile sensitivity

  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

  6th week

• Postural control

  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

  6th week

• Spatiotemporal gait parameters

  By using a stopwatch and measuring tape

  6th week

Study Arms (2)

Traditional physical therapy

ACTIVE COMPARATOR

This group received conventional physical therapy protocol along with foot care guidelines.

Other: Traditional physical therapy

Plantar cutaneous sensory stimulation.

EXPERIMENTAL

This group received plantar cutaneous sensory stimulation along with conventional physical therapy protocol and foot care guidelines.

Other: Plantar cutaneous sensory stimulation

Interventions

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.

Traditional physical therapy

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.

Plantar cutaneous sensory stimulation.

Eligibility Criteria

• Age: 45 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (2)

PhysioFit

Faisalabad, Punjab Province, 38000, Pakistan

Location

Allied Hospital Faisalabad.

Faisalābad, Punjab Province, 38000, Pakistan

Location

Related Publications (10)

• Petersen EA, Stauss TG, Scowcroft JA, Brooks ES, White JL, Sills SM, Amirdelfan K, Guirguis MN, Xu J, Yu C, Nairizi A, Patterson DG, Tsoulfas KC, Creamer MJ, Galan V, Bundschu RH, Paul CA, Mehta ND, Choi H, Sayed D, Lad SP, DiBenedetto DJ, Sethi KA, Goree JH, Bennett MT, Harrison NJ, Israel AF, Chang P, Wu PW, Gekht G, Argoff CE, Nasr CE, Taylor RS, Subbaroyan J, Gliner BE, Caraway DL, Mekhail NA. Effect of High-frequency (10-kHz) Spinal Cord Stimulation in Patients With Painful Diabetic Neuropathy: A Randomized Clinical Trial. JAMA Neurol. 2021 Jun 1;78(6):687-698. doi: 10.1001/jamaneurol.2021.0538.

  PMID: 33818600 BACKGROUND

• Castelli G, Desai KM, Cantone RE. Peripheral Neuropathy: Evaluation and Differential Diagnosis. Am Fam Physician. 2020 Dec 15;102(12):732-739.

  PMID: 33320513 BACKGROUND

• Ferreira JSSP, Cruvinel Junior RH, Silva EQ, Verissimo JL, Monteiro RL, Pereira DS, Suda EY, Sartor CD, Sacco ICN. Study protocol for a randomized controlled trial on the effect of the Diabetic Foot Guidance System (SOPeD) for the prevention and treatment of foot musculoskeletal dysfunctions in people with diabetic neuropathy: the FOotCAre (FOCA) trial I. Trials. 2020 Jan 13;21(1):73. doi: 10.1186/s13063-019-4017-9.

  PMID: 31931855 BACKGROUND

• Monteiro RL, Ferreira JSSP, Silva EQ, Donini A, Cruvinel-Junior RH, Verissimo JL, Bus SA, Sacco ICN. Feasibility and Preliminary Efficacy of a Foot-Ankle Exercise Program Aiming to Improve Foot-Ankle Functionality and Gait Biomechanics in People with Diabetic Neuropathy: A Randomized Controlled Trial. Sensors (Basel). 2020 Sep 9;20(18):5129. doi: 10.3390/s20185129.

  PMID: 32916792 BACKGROUND

• Peterson M, Pingel R, Rolandsson O, Dahlin LB. Vibrotactile perception on the sole of the foot in an older group of people with normal glucose tolerance and type 2 diabetes. SAGE Open Med. 2020 Jun 13;8:2050312120931640. doi: 10.1177/2050312120931640. eCollection 2020.

  PMID: 32587694 BACKGROUND

• Thukral N, Kaur J, Malik M. A Systematic Review and Meta-analysis on Efficacy of Exercise on Posture and Balance in Patients Suffering from Diabetic Neuropathy. Curr Diabetes Rev. 2021;17(3):332-344. doi: 10.2174/1573399816666200703190437.

  PMID: 32619175 BACKGROUND

• Khan KS, Andersen H. The Impact of Diabetic Neuropathy on Activities of Daily Living, Postural Balance and Risk of Falls - A Systematic Review. J Diabetes Sci Technol. 2022 Mar;16(2):289-294. doi: 10.1177/1932296821997921. Epub 2021 Mar 14.

  PMID: 33719603 BACKGROUND

• Akbari NJ, Naimi SS. The effect of exercise therapy on balance in patients with diabetic peripheral neuropathy: a systematic review. J Diabetes Metab Disord. 2022 Jul 4;21(2):1861-1871. doi: 10.1007/s40200-022-01077-1. eCollection 2022 Dec.

  PMID: 36404857 BACKGROUND

• Prokai J, Murlasits Z, Banhidi M, Csoka L, Greci V, Atlasz T, Vaczi M. The Effects of a 12-Week-Long Sand Exercise Training Program on Neuromechanical and Functional Parameters in Type II Diabetic Patients with Neuropathy. Int J Environ Res Public Health. 2023 Apr 5;20(7):5413. doi: 10.3390/ijerph20075413.

  PMID: 37048025 BACKGROUND

• Kang GE, Stout A, Waldon K, Kang S, Killeen AL, Crisologo PA, Siah M, Jupiter D, Najafi B, Vaziri A, Lavery LA. Digital Biomarkers of Gait and Balance in Diabetic Foot, Measurable by Wearable Inertial Measurement Units: A Mini Review. Sensors (Basel). 2022 Nov 29;22(23):9278. doi: 10.3390/s22239278.

  PMID: 36501981 BACKGROUND

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Binash Afzal, PHD*

  Riphah international university lahore campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2024
• First Posted: March 5, 2024
• Study Start: July 7, 2023
• Primary Completion: August 18, 2023
• Study Completion: September 18, 2023
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)