Comparative Effects of Propioceptive Neuromascular Facilitation and Neural Flossing in Diabetic Neuropathy

Diabetic Peripheral Neuropathy Clinical Trial

Official title:

Comparative Effects of Propioceptive Neuromascular Facilitation and Neural Flossing on Balance and Gait in Diabetic Peripheral Neuropathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06397209
• Other study ID #: REC/RCR&AHS/23/0275
• Status: Recruiting
• Phase: N/A
• Start date: December 23, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: April 2024
• Source: Riphah International University
• Contact: wajiha shahid, PhD
• Phone: 03214885079
• Email: wajishahid89[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the effects of propioceptive neuromascular facilitation and neural flossing on balance and gait in diabetic peripheral neuropathy.

Description:

In 2023,conducted systematic review to evaluate the effects of Tai Chi on postural control in people with PN. The meta-analysis found that Tai Chi therapy for people with PN resulted in a smaller sway area, in the double-leg stance with eyes closed test , than that observed in the control group, greater distance covered in the six-minute walking test and faster performance in the timed-up-and-go test, than the baseline. Tai chi effectively enhanced dynamic postural control in people with PN. However, no better effects on postural control from Tai Chi than from other rehabilitation approaches were observed in this study. In 2023,compare the effects of Functional strength training Versus Neurodynamic exercises on Balance and Gait of patients with Diabetic Peripheral Neuropathy. Both Functional Strength Training Exercises and Neurodynamic Exercises were found to improve the Balance and Gait in patients with Diabetic Peripheral Neuropathy. However, the Functional Strength Training showed more significantly improvement in Balance and Gait subsequently reducing fall and fall risk injury. As per researcher knowledge, there is no comprehensive study comparing the effects of Proprioceptive Neuromuscular Facilitation (PNF) and Neural Flossing on balance and gait in individuals with diabetic neuropathy. While both methods have been studied independently, a direct head-to-head comparison is needed. Understanding the advantages and limitations of each approach in the context of diabetic neuropathy could provide valuable insights for clinicians and researchers.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

Inclusion Criteria:

• Clinically Diagnosed with type I and II diabetes
• Patients 45 to 65 years of age
• The participants who scored <3 as per the Michigan Neuropathy Screening Instrument (MNSI) were included in the study.
• Able to stand and walk without assistance

Exclusion Criteria:

• Patients have other neurological or orthopedic impairments (such as stroke,cerebral palsy, poliomyelitis, rheumatoid arthritis, prosthesis, or moderate or severe osteoarthritis)
• Major vascular complications (venous or arterial ulcers).
• Severe retinopathy
• Severe nephropathy that causes edema or requires haemodialysis

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Other:
• Propioceptive Neuromascular facilitation
Propioceptive Neuromascular Facilitation techniques will be given for 5 days/week,10 repetitions,30 minutes/day for 8 weeks
• Neural Flossing
Neural Flossing exercises will be given for 5 days/week, 3 sets of 10 repetitions in 2 minutes for 30 minutes for 8 weeks

Locations

Country	Name	City	State
Pakistan	Dhillon Surgical Hospital	Burewala	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (13)

Barbosa M, Saavedra A, Severo M, Maier C, Carvalho D. Validation and Reliability of the Portuguese Version of the Michigan Neuropathy Screening Instrument. Pain Pract. 2017 Apr;17(4):514-521. doi: 10.1111/papr.12479. Epub 2016 Aug 19. — View Citation

Boyd BS, Nee RJ, Smoot B. Safety of lower extremity neurodynamic exercises in adults with diabetes mellitus: a feasibility study. J Man Manip Ther. 2017 Feb;25(1):30-38. doi: 10.1080/10669817.2016.1180772. Epub 2016 Jun 17. — View Citation

Ernandes RC, Brech GC, Luna NMS, Bega A, GuimarAes DS, Bocalini DS, Scherrer G, Greve JMD, Leme LEG, Alonso AC. IMPACT OF DIABETIC NEUROPATHY ON QUALITY OF LIFE AND POSTURAL BALANCE IN BRAZILIAN OLDER ADULTS. Acta Ortop Bras. 2020 Nov-Dec;28(6):275-279. doi: 10.1590/1413-785220202806234529. — View Citation

Godi M, Franchignoni F, Caligari M, Giordano A, Turcato AM, Nardone A. Comparison of reliability, validity, and responsiveness of the mini-BESTest and Berg Balance Scale in patients with balance disorders. Phys Ther. 2013 Feb;93(2):158-67. doi: 10.2522/ptj.20120171. Epub 2012 Sep 27. — View Citation

Jamal A, Ahmad I, Ahamed N, Azharuddin M, Alam F, Hussain ME. Whole body vibration showed beneficial effect on pain, balance measures and quality of life in painful diabetic peripheral neuropathy: a randomized controlled trial. J Diabetes Metab Disord. 2019 Dec 21;19(1):61-69. doi: 10.1007/s40200-019-00476-1. eCollection 2020 Jun. — View Citation

Jonsdottir J, Cattaneo D. Reliability and validity of the dynamic gait index in persons with chronic stroke. Arch Phys Med Rehabil. 2007 Nov;88(11):1410-5. doi: 10.1016/j.apmr.2007.08.109. — 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

Kluding PM, Bareiss SK, Hastings M, Marcus RL, Sinacore DR, Mueller MJ. Physical Training and Activity in People With Diabetic Peripheral Neuropathy: Paradigm Shift. Phys Ther. 2017 Jan 1;97(1):31-43. doi: 10.2522/ptj.20160124. — View Citation

Mao W, Wang T, Sun M, Zhang F, Li L. Effects of Tai Chi on Postural Control in People with Peripheral Neuropathy: A Systematic Review with Meta-Analysis. Healthcare (Basel). 2023 May 26;11(11):1559. doi: 10.3390/healthcare11111559. — View Citation

Metsker O, Magoev K, Yakovlev A, Yanishevskiy S, Kopanitsa G, Kovalchuk S, Krzhizhanovskaya VV. Identification of risk factors for patients with diabetes: diabetic polyneuropathy case study. BMC Med Inform Decis Mak. 2020 Aug 24;20(1):201. doi: 10.1186/s12911-020-01215-w. — View Citation

Mirek E, Filip M, Banaszkiewicz K, Rudzinska M, Szymura J, Pasiut S, Stozek J, Szczudlik A. The effects of physiotherapy with PNF concept on gait and balance of patients with Huntington's disease - pilot study. Neurol Neurochir Pol. 2015;49(6):354-7. doi: 10.1016/j.pjnns.2015.09.002. Epub 2015 Sep 15. — View Citation

Sartor CD, Watari R, Passaro AC, Picon AP, Hasue RH, Sacco IC. Effects of a combined strengthening, stretching and functional training program versus usual-care on gait biomechanics and foot function for diabetic neuropathy: a randomized controlled trial. BMC Musculoskelet Disord. 2012 Mar 19;13:36. doi: 10.1186/1471-2474-13-36. — View Citation

Sharma S, Kalia V. Effect of tibial nerve mobilization on balance & gait functions in subjects with subclinical diabetic neuropathy: A randomized clinical trial. J Diabetes Metab Disord. 2023 Aug 16;22(2):1283-1290. doi: 10.1007/s40200-023-01246-w. eCollection 2023 Dec. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Berg balance scale	The BBS was developed to assess the balance among elderly people with impairment in balance function by measuring the performance of functional tasks. It is a 14-item scale designed to measure the balance of the older adults in a clinical setting, and the maximum score of the scale is 56.The score between the ranges of 41-56 is considered to below risk fall, whereas 21-40 and 0-20 are considered to be medium risk fall and high risk fall, respectively.	8th week
Primary	Dynamic Gait Index	DGI assesses a person's ability to modify balance while walking in the presence of external demands. DGI is performed with a marked distance of 20 feet either with or without assistive devices. The scoring is based on a 4- point scale, and the highest possible score is 24 points. DGI score between 21 and 24 depicts safe ambulatory, whereas score of <21 is predictive of falls.	8th week