Plantar Cutaneous Sensory Stimulation in Patients With Diabetic Neuropathy

Diabetic Neuropathies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06292468
• Other study ID #: REC/RCR&AHS/23/0238
• Status: Completed
• Phase: N/A
• Start date: July 7, 2023
• Est. completion date: September 18, 2023

Study information

• Verified date: March 2024
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 18, 2023
• Est. primary completion date: August 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 67 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Peripheral Nervous System Diseases

Intervention

Other:
• Traditional 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.
• Plantar 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.

Locations

Country	Name	City	State
Pakistan	Allied Hospital Faisalabad.	Faisalabad	Punjab
Pakistan	PhysioFit	Faisalabad	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (10)

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Spatiotemporal gait parameters	By using a stopwatch and measuring tape	6th week