Biodex Balance System Training in Diabetic Neuropathy

NCT04943614 | Completed DMC

• 1 other identifier: REC/00817 Rabia
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

Type II-diabetic neuropathy is the most common and correlated problem with diabetes that deteriorates with the passage of time. Balance disorders are also resulting of movement strategy damage, biomechanical and mechanical disorientation. The balance disorder has been reported to be related to abnormal somatosensory feedback, which is utilized in the development of an interior depiction of body motion and position (inner model) in the central nervous system. The Biodex stability system offers a system that can deliver particular hip and ankle postural training strategy with external biofeedback as a monitor to enhance the reduced subclinical limitations of patients with diabetic neuropathy.

Conditions

Diabetic Neuropathies

Outcome Measures

Primary Outcomes (3)

• 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 consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete

  week 8

• Timed up and go test

  The Timed Up and Go (TUG) is a screening tool used to test basic mobility skills of frail elderly patients (60-90 years old). The TUG can be used 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

• Functional reach test

  The Functional Reach Test is a single item test developed as a quick screen for balance problems in older adults. Interpretation: A score of 6 or less indicates a significant increased risk for falls. A score between 6-10 inches indicates a moderate risk for falls

  week 8

Study Arms (2)

BIODEX training group

EXPERIMENTAL

These individuals will receive conventional along with postural stability training with biodex balance system which stimulates specific movement patterns or strategies by placing markers on a specific location on-screen grid subject attempted to touch targets nine times using an onscreen cursor manoeuvred by the subject leg on the device platform

Other: Biodex balance system

Conventional therapy group

ACTIVE COMPARATOR

These individuals will perform balance exercises including proprioception exercises, balance board exercises, walking on different surfaces, Wobble board exercise and parallel bars for ambulatory training, range of motion exercises, foot care as a home program (advices).

Other: conventional exercises

Interventions

Biodex balance system OTHER

BIODEX stability system (BIODEX Medical Systems Inc; Shirley, New York) offers a system that can deliver particular hip and ankle postural training strategy with external biofeedback as a monitor to enhance the reduced subclinical limitations of patients with diabetic neuropathy

BIODEX training group

conventional exercises OTHER

balance board exercises, walking on different surfaces, Wobble board exercise and parallel bars for ambulatory training, range of motion exercises, foot care as a home program. Same duration treatment

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:

• Age over 40 years both gender
• moderate \& severe Type 2 diabetic neuropathy (modified Toronto Clinical Neuropathy Score) 9-11 = moderate neuropathy; ≥ 12 = severe neuropathy
• Ability to stand and walk independently.
• Berg balance score \<50
• No cognitive impairments (Mini-Mental State Examination \>23)

You may not qualify if:

• Individuals with other neurological deficits.
• Type 1 diabetic neuropathy.
• Diabetic ulcer, infection or partial amputation in feet.
• Orthopedic problem or severe pain affecting balance.
• History of repeated ankle sprains
• Visual problems.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Armed Forces Institute of Rehabilitation And Medicine

Rawalpindi, Pakistan

Location

Related Publications (9)

• Vinik AI, Nevoret ML, Casellini C, Parson H. Diabetic neuropathy. Endocrinol Metab Clin North Am. 2013 Dec;42(4):747-87. doi: 10.1016/j.ecl.2013.06.001.

  PMID: 24286949 BACKGROUND

• Vincent AM, Callaghan BC, Smith AL, Feldman EL. Diabetic neuropathy: cellular mechanisms as therapeutic targets. Nat Rev Neurol. 2011 Sep 13;7(10):573-83. doi: 10.1038/nrneurol.2011.137.

  PMID: 21912405 BACKGROUND

• Peltier A, Goutman SA, Callaghan BC. Painful diabetic neuropathy. BMJ. 2014 May 6;348:g1799. doi: 10.1136/bmj.g1799.

  PMID: 24803311 BACKGROUND

• Abbott CA, Malik RA, van Ross ER, Kulkarni J, Boulton AJ. Prevalence and characteristics of painful diabetic neuropathy in a large community-based diabetic population in the U.K. Diabetes Care. 2011 Oct;34(10):2220-4. doi: 10.2337/dc11-1108. Epub 2011 Aug 18.

  PMID: 21852677 BACKGROUND

• Akbari M, Jafari H, Moshashaee A, Forugh B. Do diabetic neuropathy patients benefit from balance training? J Rehabil Res Dev. 2012;49(2):333-8. doi: 10.1682/jrrd.2010.10.0197.

  PMID: 22773533 BACKGROUND

• Pan X, Bai J. Balance training in the intervention of fall risk in elderly with diabetic peripheral neuropathy: A review. Int J Nurs Sci. 2014;1(4):441-5.

  BACKGROUND

• Ghazal J, Malik AN, Amjad I. Task oriented training improves the balance outcome & reducing fall risk in diabetic population. Pak J Med Sci. 2016 Jul-Aug;32(4):983-7. doi: 10.12669/pjms.324.10092.

  PMID: 27648053 BACKGROUND

• Singh R, Kishore L, Kaur N. Diabetic peripheral neuropathy: current perspective and future directions. Pharmacol Res. 2014 Feb;80:21-35. doi: 10.1016/j.phrs.2013.12.005. Epub 2013 Dec 25.

  PMID: 24373831 BACKGROUND

• Schwenk M, Grewal GS, Holloway D, Muchna A, Garland L, Najafi B. Interactive Sensor-Based Balance Training in Older Cancer Patients with Chemotherapy-Induced Peripheral Neuropathy: A Randomized Controlled Trial. Gerontology. 2016;62(5):553-63. doi: 10.1159/000442253. Epub 2015 Dec 18.

  PMID: 26678611 BACKGROUND

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

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

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: June 21, 2021
• First Posted: June 29, 2021
• Study Start: December 1, 2020
• Primary Completion: August 27, 2021
• Study Completion: August 27, 2021
• Last Updated: December 15, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)