Effect of Ankle Proprioception Training in Type 2 Diabetic Neuropathy

NCT05190198 | Completed DMC

• 1 other identifier: REC/00819 Anam
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetes mellitus is a metabolic disease described by hyperglycemia, which results from deficiencies in insulin secretion, the action of insulin on the target tissue, both. Chronic hyperglycemia can lead to long-standing damage and failure of various organs, including the kidneys, heart, eyes, blood vessels, and nerves. Diabetes mellitus is one of the world's biggest public health problems, affecting about 415 million people worldwide among adults aged 20 to 79 years. Patients with type 2 diabetic neuropathy (DN) are at increased risk of falls. This increased risk is likely because of the well-documented balance problems attributed to neuropathy and sensory ataxia, which is the lack of precise proprioceptive feedback. Sources of instability in patients with type 2 DN include loss or reduction of peripheral sensory information in the feet, the inability of the central nervous system (CNS) to appropriately integrate the available postural control information, and the shift from an ankle-based method to a hip-based balance strategy. In addition, increased use of vestibular information and reliance on visual information alter the style of postural control in patients with diabetic neuropathy. Individuals with diabetic peripheral neuropathy (DPN) are 15 times more likely to experience falls compared to healthy subjects.

Conditions

Diabetic Neuropathies

Outcome Measures

Primary Outcomes (4)

• Fall Efficiency Scale-International (FES-I)

  Risk of falling is assessed with Fall Efficiency Scale- International (FES-I). This is a self-reported 16-item scale of perceived confidence to complete physical daily activities. It scored each item on a four-point scale (1 = not at all concerned, 2 = somewhat concerned, 3 = fairly concerned and 4 = very concerned). The possible total score is 64 in the worst case and 16 in the best condition to do all tasks with no concern of falling.

  week 8

• Timed up and go test (TUG)

  The Timed Up and Go (TUG) is a screening tool used to test basic mobility skills of frail elderly patients (60-90 years old). They can use the TUG with but is not limited to, persons with stroke. 10s Completely independent With or without walking aid for ambulation and transfers \< 20s Independent for main transfers With or without walking aid, independent for basic tub or shower transfers and able to climb most stairs and go outside alone \> 30s Requires assistance dependent in most activities

  week 8

• Berg Balance Scale

  The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item comprising a five-point ordinal scale ranging from 0 to 4, with 0 showing the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete.

  week 8

• Modified Toronto Clinical Neuropathy Score (mTCNS)

  It is a screening tool for diabetic peripheral neuropathy and correlates with the severity of diabetic neuropathy. The mTCNS comprises two sub-scores only: symptom score and sensory test score. The values of the symptoms score range between 0 and 18 points.

  week 8

Study Arms (2)

Experimental group

EXPERIMENTAL

The experimental group will receive ankle proprioceptive training. Ankle proprioceptive training includes the following group of exercises: 1. Training on the floor for 10 minutes (1-8 weeks) 2. Training on balance pad for 10 minutes (1-4 weeks) 3. Training on rocked balance board for 10 minutes (5-8 week)

Other: Proprioceptive neuromuscular facilitation

Conventional therapy group

ACTIVE COMPARATOR

The control group will receive Traditional physical therapy exercises. 1. Active range of motion exercises for ankle and subtalar joints for 5 minutes. 2. Functional balance training for 15 minutes involving 3. Gait training for 10 minutes.

Other: conventional therapy

Interventions

Proprioceptive neuromuscular facilitation OTHER

* Weight shifting in each direction (anteriorly, posteriorly, and lateral side) combined with side-to-side head movements (5 times for each direction). * One-legged stance with slight knee flexion of another leg for 15 seconds (5 times for each leg). * One-legged stance with increasing knee flexion of the other leg for 15 seconds (5 times for each leg). * Standing on a balance pad with shifting weight (anteriorly, posteriorly, and lateral side) 10 times in each direction. * In standing position, moving the weight left and right maximally. * In standing position, moving the weight forward and backward maximally. * In standing position, moving both heels of feet up and down. * In standing position, bending and stretching both knees by squatting as much as possible.

Experimental group

conventional therapy OTHER

(Dorsiflexion, planter flexion, eversion and inversion) 10 repetitions for each movement. (A) Sit to stand (5 times). (B) Standing with shifting Weight anteriorly, posteriorly, and sideway (5 times for each direction). (C) Functional reach sideway and anterior for touching targets set by the therapist (5 times for each direction). (D) Standing on heels for 20 seconds (5 times). (E) Standing on toes for 20 seconds (5 times). (A) Spot marching (2 min). (B) Walking over the heels, toes, lateral border of feet with the preferred speed (6 min). (C) Tandem walking in a straight line (2 min).

Conventional therapy group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients having peripheral neuropathy previously diagnosed by physician / Modified Toronto Clinical Neuropathy Score 9-11 = moderate neuropathy; ≥ 12 = severe neuropathy
• Type II diabetes mellitus
• Timed up and go test \<20 sec
• Berg Balance score between 20-40
• Able to walk without assistance or assistive device
• controlled blood glucose level

You may not qualify if:

• Cognitive Deficits
• Severe retinopathy
• Severe nephropathy that causes edema or needs hemodialysis.
• Scars under their feet
• Other neurological or orthopedic impairments (such as stroke, poliomyelitis, rheumatoid arthritis, or severe osteoarthritis)
• Any medical conditions that would confound the assessment of neuropathy, such as malignancy, active/untreated thyroid disease.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Maryam Day Care Clinic Kallar Kahar

Kallar Kahar, Pakistan

Location

Related Publications (10)

• Atre JJ, Ganvir SS. Effect of functional strength training versus proprioceptive neuromuscular facilitation on balance and gait in patients with diabetic neuropathy. Indian Journal of Physical Therapy and Research. 2020;2(1):47

  BACKGROUND

• Ahmad I, Hussain E, Singla D, Verma S, Ali K. Balance training in diabetic peripheral neuropathy: A Narrative Review. JSM Diabetol Manag. 2017;2(1):1002.

  BACKGROUND

• Dominguez-Muñoz FJ, Hernández-Mocholi MA, Manso LJ, Collado-Mateo D, Villafaina S, Adsuar JC, et al. Test-retest reliability of kinematic parameters of timed up and go in people with type 2 diabetes. Applied Sciences. 2019;9(21):4709.

  BACKGROUND

• Skamagas M, Breen TL, LeRoith D. Update on diabetes mellitus: prevention, treatment, and association with oral diseases. Oral Dis. 2008 Mar;14(2):105-14. doi: 10.1111/j.1601-0825.2007.01425.x.

  PMID: 18302671 BACKGROUND

• Olokoba AB, Obateru OA, Olokoba LB. Type 2 diabetes mellitus: a review of current trends. Oman Med J. 2012 Jul;27(4):269-73. doi: 10.5001/omj.2012.68.

  PMID: 23071876 BACKGROUND

• Khan MAB, Hashim MJ, King JK, Govender RD, Mustafa H, Al Kaabi J. Epidemiology of Type 2 Diabetes - Global Burden of Disease and Forecasted Trends. J Epidemiol Glob Health. 2020 Mar;10(1):107-111. doi: 10.2991/jegh.k.191028.001.

  PMID: 32175717 BACKGROUND

• Asiimwe D, Mauti GO, Kiconco R. Prevalence and risk factors associated with type 2 diabetes in elderly patients aged 45-80 years at Kanungu District. Journal of diabetes research. 2020;2020.

  BACKGROUND

• American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2014 Jan;37 Suppl 1:S81-90. doi: 10.2337/dc14-S081. No abstract available.

  PMID: 24357215 BACKGROUND

• Saleh MS, Rehab NI. Effect of ankle proprioceptive training on gait and risk of fall in patients with diabetic neuropathy: A randomized controlled trial. International Journal of Diabetes Research. 2019;2(1):40-5.

  BACKGROUND

• Jeannin AC, Salem JE, Massy Z, Aubert CE, Vermeer C, Amouyal C, Phan F, Halbron M, Funck-Brentano C, Hartemann A, Bourron O. Inactive matrix gla protein plasma levels are associated with peripheral neuropathy in Type 2 diabetes. PLoS One. 2020 Feb 24;15(2):e0229145. doi: 10.1371/journal.pone.0229145. eCollection 2020.

  PMID: 32092076 BACKGROUND

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ayesha Afridi, PhD*

  Riphah International University

  PRINCIPAL INVESTIGATOR

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: December 29, 2021
• First Posted: January 13, 2022
• Study Start: January 15, 2022
• Primary Completion: July 27, 2022
• Study Completion: July 27, 2022
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)