- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06397209
Comparative Effects of Propioceptive Neuromascular Facilitation and Neural Flossing in Diabetic Neuropathy
Comparative Effects of Propioceptive Neuromascular Facilitation and Neural Flossing on Balance and Gait in Diabetic Peripheral Neuropathy
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: wajiha shahid, PhD
- Phone Number: 03214885079
- Email: wajishahid89@gmail.com
Study Locations
-
-
Punjab
-
Burewala, Punjab, Pakistan, 61010
- Recruiting
- Dhillon Surgical Hospital
-
Contact:
- wajiha shahid, PhD
- Phone Number: 03214885079
- Email: wajishahid89@gmail.com
-
Principal Investigator:
- Sana Akram, DPT
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: proprioceptive neuromuscular facilitation
Propioceptive neuromascular facilitation alongwith routine therapy
|
Propioceptive Neuromascular Facilitation techniques will be given for 5 days/week,10 repetitions,30 minutes/day for 8 weeks
|
|
Active Comparator: Neural flossing
Neural flossing alongwith routine therapy
|
Neural Flossing exercises will be given for 5 days/week, 3 sets of 10 repetitions in 2 minutes for 30 minutes for 8 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Berg balance scale
Time Frame: 8th week
|
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
Time Frame: 8th week
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sana Akram, DPT, Riphah International University (Lahore)
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/23/0275
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetic Peripheral Neuropathy
-
Riphah International UniversityNot yet recruitingDiabetic Peripheral NeuropathyPakistan
-
Montiha AzeemRecruitingDiabetic Peripheral NeuropathyPakistan
-
Beni-Suef UniversityNot yet recruitingDiabetic Peripheral NeuropathyEgypt
-
Ain Shams UniversityRecruitingDiabetic Peripheral Neuropathy | Diabetic Neuropathy | Diabetic Peripheral Neuropathy in Type 2 Diabetic PatientsEgypt
-
University of FaisalabadActive, not recruitingDiabetic Peripheral NeuropathyPakistan
-
Lisa GriffinRecruitingHealthy Aging | Diabetic Peripheral Neuropathy | Diabetic Peripheral Neuropathy Type 2 | Diabetic Peripheral Neuropathy Type 2 - UncontrolledUnited States
-
Min LongRecruiting
-
Riphah International UniversityRecruitingDiabetic Peripheral Neuropathy (DPN)Pakistan
-
Pamlab, L.L.C.HealthCore, Inc.CompletedDiabetic Peripheral Neuropathy (DPN)United States
-
The First Affiliated Hospital of Zhejiang Chinese...The Third Affiliated hospital of Zhejiang Chinese Medical UniversityNot yet recruitingElectroacupuncture | Diabetic Peripheral Neuropathy (DPN)
Clinical Trials on Propioceptive Neuromascular facilitation
-
Superior UniversityNot yet recruiting
-
Riphah International UniversityActive, not recruitingSports Physical TherapyPakistan
-
Universidad Miguel Hernandez de ElcheSocio- Health Center Puente Real ( Health Care for Older © ) of BadajozCompleted
-
Corporacion Parc TauliInstituto de Salud Carlos IIICompletedSleep Disorder | Hyperphagia | Behavior DisordersSpain
-
Assiut UniversityNot yet recruiting
-
VA Office of Research and DevelopmentCompleted
-
South Central VA Mental Illness Research, Education...CompletedDepressionUnited States
-
Noctem, LLCUnited States Department of Defense; Naval Health Research Center; US Air Force... and other collaboratorsActive, not recruitingChronic Insomnia | Implementation; Digital HealthUnited States
-
Northwestern UniversityUniversity of Utah; Pastors 4 PCORRecruitingHypertensionUnited States