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

NCT06397209 | Recruiting

• 1 other identifier: REC/RCR&AHS/23/0275
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetic Peripheral Neuropathy

Keywords

Diabetic Peripheral Neuropathy; Michigan Neuropathy Screening Instrument; Neural Flossing; Propioceptive Neuromascular facilitation

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

proprioceptive neuromuscular facilitation

EXPERIMENTAL

Propioceptive neuromascular facilitation alongwith routine therapy

Other: Propioceptive Neuromascular facilitation

Neural flossing

ACTIVE COMPARATOR

Neural flossing alongwith routine therapy

Other: Neural Flossing

Interventions

Propioceptive Neuromascular facilitation OTHER

Propioceptive Neuromascular Facilitation techniques will be given for 5 days/week,10 repetitions,30 minutes/day for 8 weeks

proprioceptive neuromuscular facilitation

Neural Flossing OTHER

Neural Flossing exercises will be given for 5 days/week, 3 sets of 10 repetitions in 2 minutes for 30 minutes for 8 weeks

Neural flossing

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Dhillon Surgical Hospital

Burewala, Punjab Province, 61010, Pakistan

RECRUITING

Related Publications (13)

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  PMID: 26652868 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

• 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.

  PMID: 28855790 BACKGROUND

• 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.

  PMID: 27445060 BACKGROUND

• 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.

  PMID: 32831065 BACKGROUND

• 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.

  PMID: 37297699 BACKGROUND

• 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.

  PMID: 33328782 BACKGROUND

• 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.

  PMID: 32550157 BACKGROUND

• 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.

  PMID: 22429765 BACKGROUND

• 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.

  PMID: 27538385 BACKGROUND

• 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.

  PMID: 23023812 BACKGROUND

• 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.

  PMID: 17964880 BACKGROUND

• 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.

  PMID: 37975109 BACKGROUND

Study Officials

• Sana Akram, DPT

  Riphah International University (Lahore)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

wajiha shahid, PhD

CONTACT

03214885079; wajishahid89@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 2, 2024
• Study Start: December 23, 2023
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: May 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)