Effects of Whole Body Vibration in Diabetic Peripheral Neuropathy .

NCT05058807 | Completed DMC

• 1 other identifier: Quratulain
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to conduct a randomized controlled trail to compare and analyze the effects of both whole body vibrator (WBV) and Tai Chi program on static and dynamic postural balance variables of the diabetic population. The purpose of the study is to determine that whether whole body vibrator is more evident for promoting functional independency and improving balance in diabetic neuropathy. Hence distinguishing choices to prevent fall and advancing functional independency by using the appropriate intervention without using extreme loads.

Conditions

Diabetic Neuropathies

Outcome Measures

Primary Outcomes (2)

• •Berg Balance Scale

  BBS is a gold standard tool, developed by Berg et al. in 1998 for functional assessment of balance. It has been widely used for older people with balance impairments, stroke, Parkinson's disease, vestibular disorders and in different healthcare settings (7,23). It consists of 14 items to detect static (5 items) and dynamic (9 items) balance. Each item has a score of 0-4 on ordinal scale. Total score is 56, higher the score better is the balance. 0-20 indicates poor balance and predicts high risk of fall, 21-40 indicates acceptable balance and medium fall risk and 41-56 indicates good balance and low fall risk (7, 24). BBS exhibits an excellent reliability; test-retest (ICC) = 0.91) and inter-rater (ICC = 0.97). This scale also has some limitations such as it has a little focus on gait and dynamic balance. Secondly, it has ceiling effect that was reported as 22.5% in community-dwelling older adults

  Change from Baseline mobility and balance to 4th week, 8 Weeks

• 5 times sit to stand test

  To evaluate lower-limb muscle strength, the five-times-sit-to stand (FTSTS) test was used. For this test, the subject was asked to sit in an armless chair (with its back supported against a wall) with arms crossed over his/her chest and then instructed to stand and sit five times as quickly as possible. The same chair was used for all subjects. Subjects performed two timed trials. The instructor commenced the test with "Ready, Set, Go", started a digital stopwatch on "Go," and counted aloud each of the five completed sit to stand cycles. The stopwatch was stopped when the subject returned to the seated position for the fifth time

  Change from Baseline balance to 4th week ,8th Weeks

Secondary Outcomes (1)

• Single leg stance test

  Change from Baseline , balance and fall prevention to 4Weeks, 8 weeks

Study Arms (2)

Whole body vibration group

EXPERIMENTAL

Experimental Group will receive WBV training and balance exercises under the supervision of a physical therapist by using a vibration platform. Balance exercises include: Double leg stance with eyes open and eyes closed 10 Reps \* 3 minutes Tandem walk for 3 minutes Sideways walk for 3 minutes Single leg stance for 1 minute with 5 Reps, with 30 sec rest interval WHOLE BODY VIBRATION: The patient stood on the platform with his/her feet barefoot shoulder width and stared at the front, delivered on a side alternating vibration platform in an intermittent way: five repetitions of 1 min vibration followed by a 1 min rest. The vibration frequency and amplitude were 20 Hz and 3.0 mm respectively. These outcomes will be evaluated at baseline, and after 4 week and at 8th week

Other: Whole body vibration group

TAI CHI Group

ACTIVE COMPARATOR

Control group will receive Balance exercises include: Double leg stance with eyes open and eyes closed 10 Reps \* 3 minutes Tandem walk for 3 minutes Sideways walk for 3 minutes Single leg stance for 1 minute with 5 Reps ,with 30 sec rest interval Yang style Tai chi exercise which consist of 10 positions. 1\. Hold the ball ward off 2: Grasping the sparrows tail left; 3.Grasping the sparrows tail Right;; 5.Repulse Monkey; 6. Part wild horse's Mane; 7.Brush knee Twist step; 8.Lift kick left; .Lift kick Right; 10.Cross hands with double leg stance 1st and 2nd week will last for 5reps, 3rd and 4th week will last for 10reps,5th and 6th week will last for 15reps,7th and 8th week will last for 20reps, starting with 10 minutes warming- up and ending with 10 minutes cool-down. These outcomes will be evaluated at baseline, and after 4 week and at 8th week.

Other: Tai Chi group

Interventions

Whole body vibration group OTHER

Experimental Group will receive WBV training and balance exercises under the supervision of a physical therapist by using a vibration platform. Balance exercises include: Double leg stance with eyes open and eyes closed 10 Reps \* 3 minutes Tandem walk for 3 minutes Sideways walk for 3 minutes Single leg stance for 1 minute with 5 Reps, with 30 sec rest interval WHOLE BODY VIBRATION: The patient stood on the platform with his/her feet barefoot shoulder width and stared at the front, delivered on a side alternating vibration platform in an intermittent way: five repetitions of 1 min vibration followed by a 1 min rest. The vibration frequency and amplitude were 20 Hz and 3.0 mm respectively. These outcomes will be evaluated at baseline, and after 4 week and at 8th week

Whole body vibration group

Tai Chi group OTHER

Control group will receive Balance exercises include: Double leg stance with eyes open and eyes closed 10 Reps \* 3 minutes Tandem walk for 3 minutes Sideways walk for 3 minutes Single leg stance for 1 minute with 5 Reps ,with 30 sec rest interval Yang style Tai chi exercise which consist of 10 positions. 1. Hold the ball ward off 2: Grasping the sparrows tail left; 3.Grasping the sparrows tail Right;; 5.Repulse Monkey; 6. Part wild horse's Mane; 7.Brush knee Twist step; 8.Lift kick left; 9.Lift kick Right; 10.Cross hands with double leg stance 1st and 2nd week will last for 5reps, 3rd and 4th week will last for 10reps,5th and 6th week will last for 15reps,7th and 8th week will last for 20reps, starting with 10 minutes warming- up and ending with 10 minutes cool-down. These outcomes will be evaluated at baseline, and after 4 week and at 8th week

TAI CHI Group

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Balance : 21-52
• DM type II from past 10 years
• American Diabetes Association (ADA) guideline 2001 or using oral hypoglycemic agent; HbA1C \< 8.5 %
• Taking Medicine and stable patients
• MMSE\>25
• Michigan Diabetic Neuropathy Score (MDNS) between 13 and 29 (mild to moderate neuropathy)

You may not qualify if:

• Patients with any musculoskeletal impairment (such as inability to walk independently), vision impairment, vestibular diseases with a diabetes-related etiology, or dementia (Mini-Mental State Examination score \< 24/30)

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Pakistan General Railway Hospital

Rawalpindi, Islamabad, 46000, Pakistan

Location

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

• Misbah ghous, MS

  Riphah International University Islamabad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: September 28, 2021
• Study Start: October 1, 2021
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: December 12, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)