ClinicalTrials.gg
Status unknownNCT06397209Updated May 2, 2024

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

An interventional study of Propioceptive Neuromascular facilitation and Neural Flossing in Diabetic Peripheral Neuropathy, sponsored by Riphah International University. Status unknown at 1 site in Pakistan. Open to participants aged 45 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-05-02.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2024), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Dec 2023, registered Apr 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
45 Years to 65 Years
Sex
All
01

Study summary

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

Read the detailed 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.

02

Conditions studied

  • Diabetic Peripheral Neuropathy

Keywords

  • Diabetic Peripheral Neuropathy
  • Michigan Neuropathy Screening Instrument
  • Neural Flossing
  • Propioceptive Neuromascular facilitation
03

In context

Lead sponsor

Riphah International University is the lead sponsor of 2,176 studies on the registry; 637 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    proprioceptive neuromuscular facilitation

    Propioceptive neuromascular facilitation alongwith routine therapy

    Other: Propioceptive Neuromascular facilitation

  • Active comparator
    Neural flossing

    Neural flossing alongwith routine therapy

    Other: Neural Flossing

Interventions

  • OtherPropioceptive Neuromascular facilitation

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

  • OtherNeural 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 8th week

  2. 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.

    Time frame: 8th week

07

Study locations

1 of 1 sites recruiting
  • Dhillon Surgical Hospital
    Burewala, Punjab Province 61010, Pakistan
    • wajiha shahid, PhD · Contact · wajishahid89@gmail.com · 03214885079
    • Sana Akram, DPT · Principal investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 26652868 ↗
  • 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. PubMed 33719603 ↗
  • 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. PubMed 28855790 ↗
  • 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. PubMed 27445060 ↗
  • 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. PubMed 32831065 ↗
  • 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. PubMed 37297699 ↗
  • 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. PubMed 33328782 ↗
  • 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. PubMed 32550157 ↗
  • 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. PubMed 22429765 ↗
  • 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. PubMed 27538385 ↗
  • 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. PubMed 23023812 ↗
  • 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. PubMed 17964880 ↗
  • 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. PubMed 37975109 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Dec 2023 (actual). Primary completion is estimated for Sep 2024, 8 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 29, 2024
First posted
May 2, 2024
StartActual
Dec 23, 2023
Primary completionEst.
Sep 1, 2024
CompletionEst.
Oct 1, 2024
Last update
May 2, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06397209
Responsible party
Sponsor
First posted
May 2, 2024
Start date
Dec 23, 2023
Primary completion
Sep 1, 2024 (estimated)
Completion
Oct 1, 2024 (estimated)
Last update
May 2, 2024

Study contacts

wajiha shahid, PhD
Contact
wajishahid89@gmail.com
03214885079
Sana Akram, DPT
principal investigator · Riphah International University (Lahore)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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