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Biodex Balance System Training in Diabetic Neuropathy

Primary Purpose

Diabetic Neuropathies

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Biodex balance system
conventional exercises
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Neuropathies

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.

Sites / Locations

  • Armed Forces Institute of Rehabilitation And Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BIODEX training group

Conventional therapy group

Arm Description

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

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).

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

Full Information

First Posted
June 21, 2021
Last Updated
December 13, 2021
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04943614
Brief Title
Biodex Balance System Training in Diabetic Neuropathy
Official Title
Effect of BIODEX Balance System Training on Balance in Type II-diabetic Neuropathy.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
August 27, 2021 (Actual)
Study Completion Date
August 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Diabetes mellitus is one of the most common critical illnesses with a higher prevalence all over the world. Diabetic neuropathy is the most common and correlated problem with diabetes that deteriorates with the passage of time. Diabetic neuropathy is a progressive and complex disease, characterized by regular distal deterioration of peripheral nerves which lead to symptoms of sensory loss and pain. During normal situations, somatosensory inputs from the feet and legs participate in the stability of posture. Posture reflex and balance alignment are common findings in diabetic neuropathy because of reduced proprioception and rising time of reflex reactions. Balance disorders are also results of movement strategy damage, biomechanical and mechanical disorientation. About 20-30% of patients with diabetic neuropathy suffer from neuropathic pains. Neuropathic complications are prevalent among 39.6% of the diabetic population. Diabetic neuropathy lowers significantly the quality of life and considerably increases health expenses related to diabetes. Diabetic neuropathy patients exhibit stability disorders and are vulnerable to falls even with open eyes. The instability sources in patients with type-II diabetic neuropathy comprise the incapability of the central nervous system (CNS) to integrate properly available information of postural control and a shift of balance strategy from ankle-based to hip-based. Furthermore, a rise in the reliance on visual information and the use of vestibular information change the format of postural control in patients with diabetic neuropathy. Stability can be referred to as the warmth of a dynamic system to different worries, and local constancy is the sensitivity of the structure to internal distresses, for example, natural fluxes like variation in muscle activity respond to gravity which occurs during stability. The impacts of such natural variations were inspected for assessing diverse measures of postural influence. Multiple studies on diabetic patients by neuropathic postural instability recommend relative shortfalls in their capability to sustain posture and specify higher instability as compared to non-diabetics and positive relations between falling and postural instability. Moreover, studies of posture instability in diabetic patients with diabetic neuropathy have shown greater scores for postural stability indexes, area of sway, speed, greater ranges of the centre of pressure; increased values of the centre of mass variables and increase of sway power in less stable postures. Awareness and appropriately performing balance and stability training in patients involve comprehensive knowledge of the causes of postural complications. Postural control involves a composite organization that controls the equilibrium and orientation of the body during upright stand. In addition, posture control involves multiple underlying physiological organizations and dependent upon six contexts: (a) cognitive processing, (b) sensory approaches, (c) movement approaches, (d) dynamics control (e), space orientation and (f) biomechanical task limitations. The sensory afferents sources which seem to participate in postural control comprise proprioception, visual systems, and vestibular. Subclinical and pathological constrictions in patients with diabetic neuropathy are because of context-specific and distinct instabilities like sensory and movement approaches. Reactive movement approaches are helpful for patients in developing multi-joint coordinated movement, and sensory approaches for selecting proper sensory information to control posture. The hip and ankle reactive movement approach reported being helpful to return the equilibrium of the body and keeping the feet in position. When people stand on a rigid surface, the ankle approach maintains balance with little movements in the form of an inverted pendulum. Rehabilitation and reactive movement strategies comprise the patient's exposure to external perturbations which differ in direction, amplitude, and speed. However, few studies have reported the correlation between balance training and external response. These trainings are useful to progress the sensory integration and dynamic balance capabilities of aged adults with a falling history and support for frail aged women in domestic care. It also has been ideal to balance training at home. In addition, static-standing stability can be trained efficiently through weight-bearing exercise, and a visual guided weight-shifting drill can develop a standing balance mechanism of static balance in diabetic neuropathy patients. Like so, 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. As these patients are often of old age and have symptoms of instability identical to those of elder people, it is supposed that a balance-training platform with a BIODEX balance system may also improve balance in patients with diabetic neuropathy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathies

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BIODEX training group
Arm Type
Experimental
Arm Description
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
Arm Title
Conventional therapy group
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Biodex balance system
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
conventional exercises
Intervention Description
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
Primary Outcome Measure Information:
Title
Berg Balance Scale
Description
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
Time Frame
week 8
Title
Timed up and go test
Description
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
Time Frame
week 8
Title
Functional reach test
Description
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
Time Frame
week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayesha Afridi, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Armed Forces Institute of Rehabilitation And Medicine
City
Rawalpindi
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24286949
Citation
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.
Results Reference
background
PubMed Identifier
21912405
Citation
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.
Results Reference
background
PubMed Identifier
24803311
Citation
Peltier A, Goutman SA, Callaghan BC. Painful diabetic neuropathy. BMJ. 2014 May 6;348:g1799. doi: 10.1136/bmj.g1799. Erratum In: BMJ. 2014;348:g3440.
Results Reference
background
PubMed Identifier
21852677
Citation
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.
Results Reference
background
PubMed Identifier
22773533
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
27648053
Citation
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.
Results Reference
background
PubMed Identifier
24373831
Citation
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.
Results Reference
background
PubMed Identifier
26678611
Citation
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.
Results Reference
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Biodex Balance System Training in Diabetic Neuropathy

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