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BRACE(Balance, Resistance, Aerobic and Cognitive Exercise) Protocol for Diabetic).Peripheral Neuropathic Patients.

Primary Purpose

Diabetic Peripheral Neuropathy (DPN)

Status
Unknown status
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
RACE Protocol: Balance training along with resistance, aerobic and cognitive exercises.
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Peripheral Neuropathy (DPN) focused on measuring Diabetic Peripheral Neuropathy, Balance training, Strengthening, Cognitive exercises, Aerobics exercises

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with type-2 Diabetes
  • Diabetes of more than 5 years of the duration

Exclusion Criteria:

  • Patients have vertebrobasilar insufficiency (tested by VBI tests)
  • Atlanto-axial instability (tested by sharp purser test)
  • Osteoporosis
  • Rheumatoid arthritis
  • Neuropathies
  • Recent surgeries

Sites / Locations

  • Riphah International UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Balance Training Home plan

BRACE Protocol: Balance training along with resistance, aerobic and cognitive excercises

Arm Description

The Control group is undergoing balance training only, 3 days a week, and will be for 8 weeks. Balance training includes 10minutes of warm-up and 30 minutes of balance exercises. A force plate will be used to measure the postural sways. Measurements will be taken at a base-line, after the first session, at mid-level (4th week) and at the end (8th week). These exercises include Static Balance exercises(1-2weeks): Romberg with eyes open & close, Tandem standing with eyes open & close with alternate feet, Single leg stance. Static/ Dynamic/ Anticipatory Postural Control (3-4weeks): Sit to Stand, FRT( forward reach test) that is forward, sideways, cross reach, and timed up and go test. Static/ Dynamic/ Anticipatory? Reactive Postural Control (5-6weeks): Perturbations: Controlled by the therapist in sitting & standing, Throwing a ball, kicking a ball. (7-8weeks): Combination of All

BRACE protocol for balance training 3 days a week for 8 consecutive weeks on alternate days. These exercises include Static Balance exercises(1-2weeks) plus Chair rise 30 sec without using hands, 6-minute walk, count reverse from 50, push the wall, and reverse count from 20. Static, dynamic, anticipatory postural control (3-4weeks) plus Stair climbing without using rails, marching in space, remember 5 words, name 5 animals, repeat 5 words, spell the word like APPLE, spell backward again. Static, dynamic, anticipatory postural control (5-6weeks) plus Squatting, cycling, count even numbers from 1-50. calculation: Addition, subtraction, multiplication, division. (7-8weeks): Combination of all.

Outcomes

Primary Outcome Measures

Berg Balance Scale
To objectively determine a patient's ability (or inability) to safely balance during a series of pre-determined 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 with a total of 56 scores. This scale is interpreted as 0-20 on the BBS represents balance impairment; 21-40 on the BBS represents acceptable balance; 41-56 on the BBS represents a good balance. Measurements will be taken at a base-line, after the first session, at mid-level (4th week) and at the end (8th week).

Secondary Outcome Measures

TUG test
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance.[1] It uses the time that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees. The scores of ten seconds or less indicate normal mobility, 11-20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention. A score of 30 seconds or more suggests that the person may be prone to falls. Measurements will be taken at a base-line, after the first session, at mid-level (4th week) and at the end (8th week).
FRT test
Functional Reach Test (FRT) is a clinical outcome measure and assessment tool for ascertaining dynamic balance in one simple task. In standing, measures the distance between the length of an outstretched arm in a maximal forward reach, while maintaining a fixed base of support. This information is correlated with the risk of falling. Measurement Interpretation: 10"/25 cm or greater Low risk of falls; 6"/15cm to 10"/25cm Risk of falling is 2x greater than normal; 6"/15cm or less Risk of falling is 4x greater than normal; Unwilling to reach Risk of falling is 8x greater than normal. Measurements will be taken at a base-line, after the first session, at mid-level (4th week) and at the end (8th week).
MoCA
The Montreal Cognitive Assessment (MoCA) is a widely used screening assessment for detecting cognitive impairment. MoCA scores range between 0 and 30. A score of 26 or over is considered to be normal. In a study, people without cognitive impairment score an average of 27.4; people with mild cognitive impairment (MCI) score an average of 22.1; people with Alzheimer's disease score an average of 16.2. Measurements will be taken at a base-line, after the first session, at mid-level (4th week) and at the end (8th week).
Postural sway
A force plate will be used to measure the postural sways. Measurements will be taken at a base-line, after the first session, at mid-level (4th week) and at the end (8th week).
Gait and Posture assessment by application
A mobile application (Gait and posture) will be used to measure the postural sways and balance. Measurements will be taken at a base-line, after the first session, at mid-level (4th week) and at the end (8th week).
Michigan Neuropathy Screening Instrument
The Michigan Neuropathy Screening Instrument (MNSI) is designed to screen for the presence of diabetic neuropathy. The first part of the screening instrument, the history questionnaire, consists of 15 self-administered "yes or no" questions on foot sensation including pain, numbness, and temperature sensitivity. A higher score (out of a maximum of 13 points) indicates more neuropathic symptoms. The second part of the MNSI is a brief physical assessment (completed by health professionals). Patients screening positive on the clinical portion of the MNSI (greater than 2 points on a 10 point scale) are considered neuropathic and referred for further evaluation. A force plate will be used to measure the postural sways. Measurements will be taken at a base-line, after the first session, at mid-level (4th week) and at the end (8th week).

Full Information

First Posted
March 29, 2021
Last Updated
September 8, 2021
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04832464
Brief Title
BRACE(Balance, Resistance, Aerobic and Cognitive Exercise) Protocol for Diabetic).Peripheral Neuropathic Patients.
Official Title
Effects of BRACE (Balance, Resistance, Aerobic and Cognitive Exercise) Protocol for Balance Training in Patients With Diabetic Peripheral Neuropathy.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 30, 2021 (Actual)
Primary Completion Date
February 27, 2022 (Anticipated)
Study Completion Date
February 27, 2022 (Anticipated)

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
No

5. Study Description

Brief Summary
The purpose of the study is to determine the effects of the BRACE( Balance, Resistance, Aerobic and Cognitive Exercise) protocol for balance training in patients with Diabetic Peripheral Neuropathy. A Randomized Control Trial is being conducted at Railways General Hospital, Rawalpindi. The sample size was calculated through the open epi tool. A total of 60 patients are divided into two groups, 30 participants in the experimental group and 30 participants in the control group. The study duration will be six months. The sampling technique applied was simple random sampling for recruitment and group randomization using the sealed envelope method. Patients with the age of 40-65 years having type II diabetes for more than 5 years are included in the study. Tools used in the study are Berg balance scale, timed up and go test, functional reach test, Montreal Cognitive Assessment scale (MOCA), and force plate. Data will be analyzed through Statistical Package for the Social Sciences (SPSS), version 21.
Detailed Description
American Diabetic Association (ADA) defined Diabetes mellitus as a group of metabolic diseases characterized by hyperglycemia resulting from defects in insulin secretion, insulin action, or both. The chronic hyperglycemia of diabetes is associated with dysfunction of various organs, especially the eyes, kidneys, nerves, heart, and blood vessels. Most common among the neuropathies are chronic sensorimotor distal symmetric polyneuropathy (DPN) and autonomic neuropathies. According to ADA(American Diabetes Association), DPN(Diabetic Peripheral Neuropathy) is "the presence of symptoms and/or signs of peripheral nerve dysfunction in people with diabetes after exclusion of other causes. It is estimated that 60% to 70% of individuals with diabetes have mild to severe forms of nervous system damage. DPN(Diabetic Peripheral Neuropathy) causes decreased sensation, proprioception, reflexes, and strength in the lower extremities, leading to balance dysfunction. Physical therapy interventions utilized to reduce the balance dysfunction can range from restoration of the health of the neurons to sensory integration to compensatory strategies. Various treatment protocols include improving circulation, the guided practice of integrating internal and external sensory input, education on sensation loss and fall risk, instruction on home modifications, and introduction of assistive devices to minimize balance dysfunction. A systematic and evidence-based search of relevant literature was performed by utilizing PubMed and Google Scholar as search engines. Search term for the initial literature review was Diabetes mellitus, the prevalence of DPN(diabetic peripheral neuropathy), causes of peripheral neuropathies and loss of balance, the pathophysiology of diabetes-related peripheral neuropathy, treatment options for balance training, strengthening lower extremities, aerobics, cognitive approach. The search was limited to papers in English preferably published since 2000 with full text available. Different studies were available regarding balance exercises and their effects but limited data was available regarding BRACE ( Balance, Resistance, Anaerobic, and Cognitive Exercise) protocol as a whole in recent years. Balance exercises are feasible and safe and have the potential to improve balance and gait. These should be used as supportive therapy for DPN patients. Lower extremity resistance (strengthening) exercises are fairly recommended for clinical use in treating balance dysfunction in patients with DPN than monochromatic infrared energy therapy, vibrating insoles, and use of a cane. Previously, walking and weight-bearing were considered contraindicated in DPN patients to avoid foot ulcers, deformity, or fall risk. Emerging research has revealed positive adaptations in response to overload stress in these people, including evidence for peripheral neuroplasticity in animal models and early clinical trials. According to WHO estimation, a number of individuals approximately 47 million worldwide have cognitive impairments which will increase to 75 million by 2030. A 2 years longitudinal study in Korea showed a significant association between cognitive decline and physical activity. Pain interference may be reduced following an aerobic exercise intervention among people with painful DPN, without a change in pain intensity. Although, multiples researches have shown the effects of particular interventions on DPN still there is a lack of multi-component interventional studies to show the effects on balance issues.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Peripheral Neuropathy (DPN)
Keywords
Diabetic Peripheral Neuropathy, Balance training, Strengthening, Cognitive exercises, Aerobics exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Outcomes assessor and participants.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Balance Training Home plan
Arm Type
Active Comparator
Arm Description
The Control group is undergoing balance training only, 3 days a week, and will be for 8 weeks. Balance training includes 10minutes of warm-up and 30 minutes of balance exercises. A force plate will be used to measure the postural sways. Measurements will be taken at a base-line, after the first session, at mid-level (4th week) and at the end (8th week). These exercises include Static Balance exercises(1-2weeks): Romberg with eyes open & close, Tandem standing with eyes open & close with alternate feet, Single leg stance. Static/ Dynamic/ Anticipatory Postural Control (3-4weeks): Sit to Stand, FRT( forward reach test) that is forward, sideways, cross reach, and timed up and go test. Static/ Dynamic/ Anticipatory? Reactive Postural Control (5-6weeks): Perturbations: Controlled by the therapist in sitting & standing, Throwing a ball, kicking a ball. (7-8weeks): Combination of All
Arm Title
BRACE Protocol: Balance training along with resistance, aerobic and cognitive excercises
Arm Type
Experimental
Arm Description
BRACE protocol for balance training 3 days a week for 8 consecutive weeks on alternate days. These exercises include Static Balance exercises(1-2weeks) plus Chair rise 30 sec without using hands, 6-minute walk, count reverse from 50, push the wall, and reverse count from 20. Static, dynamic, anticipatory postural control (3-4weeks) plus Stair climbing without using rails, marching in space, remember 5 words, name 5 animals, repeat 5 words, spell the word like APPLE, spell backward again. Static, dynamic, anticipatory postural control (5-6weeks) plus Squatting, cycling, count even numbers from 1-50. calculation: Addition, subtraction, multiplication, division. (7-8weeks): Combination of all.
Intervention Type
Other
Intervention Name(s)
RACE Protocol: Balance training along with resistance, aerobic and cognitive exercises.
Other Intervention Name(s)
Balance Training Home plan
Intervention Description
therapy for the preservation, enhancement, or restoration of movement and physical function impaired or threatened by disease, injury, or disability that utilizes therapeutic exercise, physical modalities (such as massage and electrotherapy), assistive devices, and patient education and training.
Primary Outcome Measure Information:
Title
Berg Balance Scale
Description
To objectively determine a patient's ability (or inability) to safely balance during a series of pre-determined 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 with a total of 56 scores. This scale is interpreted as 0-20 on the BBS represents balance impairment; 21-40 on the BBS represents acceptable balance; 41-56 on the BBS represents a good balance. Measurements will be taken at a base-line, after the first session, at mid-level (4th week) and at the end (8th week).
Time Frame
Up to 8 weeks
Secondary Outcome Measure Information:
Title
TUG test
Description
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance.[1] It uses the time that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees. The scores of ten seconds or less indicate normal mobility, 11-20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention. A score of 30 seconds or more suggests that the person may be prone to falls. Measurements will be taken at a base-line, after the first session, at mid-level (4th week) and at the end (8th week).
Time Frame
Up to 8 weeks
Title
FRT test
Description
Functional Reach Test (FRT) is a clinical outcome measure and assessment tool for ascertaining dynamic balance in one simple task. In standing, measures the distance between the length of an outstretched arm in a maximal forward reach, while maintaining a fixed base of support. This information is correlated with the risk of falling. Measurement Interpretation: 10"/25 cm or greater Low risk of falls; 6"/15cm to 10"/25cm Risk of falling is 2x greater than normal; 6"/15cm or less Risk of falling is 4x greater than normal; Unwilling to reach Risk of falling is 8x greater than normal. Measurements will be taken at a base-line, after the first session, at mid-level (4th week) and at the end (8th week).
Time Frame
Up to 8 weeks
Title
MoCA
Description
The Montreal Cognitive Assessment (MoCA) is a widely used screening assessment for detecting cognitive impairment. MoCA scores range between 0 and 30. A score of 26 or over is considered to be normal. In a study, people without cognitive impairment score an average of 27.4; people with mild cognitive impairment (MCI) score an average of 22.1; people with Alzheimer's disease score an average of 16.2. Measurements will be taken at a base-line, after the first session, at mid-level (4th week) and at the end (8th week).
Time Frame
Up to 8 weeks
Title
Postural sway
Description
A force plate will be used to measure the postural sways. Measurements will be taken at a base-line, after the first session, at mid-level (4th week) and at the end (8th week).
Time Frame
Up to 8 weeks
Title
Gait and Posture assessment by application
Description
A mobile application (Gait and posture) will be used to measure the postural sways and balance. Measurements will be taken at a base-line, after the first session, at mid-level (4th week) and at the end (8th week).
Time Frame
Up to 8 weeks
Title
Michigan Neuropathy Screening Instrument
Description
The Michigan Neuropathy Screening Instrument (MNSI) is designed to screen for the presence of diabetic neuropathy. The first part of the screening instrument, the history questionnaire, consists of 15 self-administered "yes or no" questions on foot sensation including pain, numbness, and temperature sensitivity. A higher score (out of a maximum of 13 points) indicates more neuropathic symptoms. The second part of the MNSI is a brief physical assessment (completed by health professionals). Patients screening positive on the clinical portion of the MNSI (greater than 2 points on a 10 point scale) are considered neuropathic and referred for further evaluation. A force plate will be used to measure the postural sways. Measurements will be taken at a base-line, after the first session, at mid-level (4th week) and at the end (8th week).
Time Frame
Up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with type-2 Diabetes Diabetes of more than 5 years of the duration Exclusion Criteria: Patients have vertebrobasilar insufficiency (tested by VBI tests) Atlanto-axial instability (tested by sharp purser test) Osteoporosis Rheumatoid arthritis Neuropathies Recent surgeries
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, PhD
Phone
(+92)3324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Imran Amjad, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International University
City
Islamabad
State/Province
Fedral
ZIP/Postal Code
44000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Imran Amjad, PhD
Email
imran.amjad@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Azka Tariq, MSNMPT*

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Pandey S, Raj IJS. Comparison of Game Based Rehabilitation and Mixed Sport Training on Balance in Diabetic Neuropathy: Lovely Professional University; 2017
Results Reference
background
PubMed Identifier
23264425
Citation
American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2013 Jan;36 Suppl 1(Suppl 1):S67-74. doi: 10.2337/dc13-S067. No abstract available.
Results Reference
background
Citation
O'Sullivan SB, Schmitz TJ, Fulk G. Physical rehabilitation: FA Davis; 2019
Results Reference
background
PubMed Identifier
27445060
Citation
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.
Results Reference
background
Citation
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):1-9
Results Reference
background
PubMed Identifier
29422020
Citation
Wallin A, Kettunen P, Johansson PM, Jonsdottir IH, Nilsson C, Nilsson M, Eckerstrom M, Nordlund A, Nyberg L, Sunnerhagen KS, Svensson J, Terzis B, Wahlund LO, Georg Kuhn H. Cognitive medicine - a new approach in health care science. BMC Psychiatry. 2018 Feb 8;18(1):42. doi: 10.1186/s12888-018-1615-0.
Results Reference
background
Citation
Kiani N, Marryam M, Malik AN, Amjad I. The effect of aerobic exercises on balance in diabetic neuropathy patients. Journal Of Medical Sciences. 2018;26(2):141-5
Results Reference
background

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BRACE(Balance, Resistance, Aerobic and Cognitive Exercise) Protocol for Diabetic).Peripheral Neuropathic Patients.

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