Balance Training in Diabetic Neuropathy

Efficacy of Balance Training in Comparison to General Exercises Alone in Diabetic Neuropathy

This study evaluates the efficacy of balance training in Diabetic Neuropathy. Control group will receive general exercises while Eperimental/ Interventional group will receive Balance exercises along with general exercises.

Study Overview

• Status: Completed
• Conditions: Diabetic Neuropathy With Neurologic Complication
• Intervention / Treatment: Other: Balance Training; Other: General Exercises

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74200
      • Institute of physical medicine and rehabilitation, Dow University of health sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age group: 30-60 years
• Diabetes type II patients diagnosed with peripheral neuropathy by medical doctor for at least 5 years
• Neuropathy present (on the basis of Michigan Neuropathy Screening Instrument
• Have balance impairment ( evaluation on Berg Balance Scale)

Exclusion Criteria:

• Neuropathy due to other medical conditions like Vitamin deficiency, Hypothyroidism, Auto-immune/ demyelinating diseases
• Foot ulcers
• Lower limb amputee
• Vestibular diseases
• Retinopathy
• Cardiac problems
• Hemiplegia/ Stroke

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental Group; Balance training by 9 positions with 1 min hold, repeated twice; Stand with feet together, eyes remain open; Stand with together, eyes closed; & 4) Tandem Standing with Right and Left in front alternately 5) Forward Reaching 6) & 7) Single Leg Standing, with Right and Left foot alternately 8) & 9) Step up, with Right and Left foot alternately General Exercises for 25 min; Active Range of Motion Exercises and Foot Care Education-5 min; Treadmill- 15 min; Cycling -5 min No. Of Sessions 24, thrice a week for 8 weeks	Other: Balance Training; Balance enhancing exercises; Other: General Exercises; General Exercises
ACTIVE_COMPARATOR: Control Group; General Exercises for 25 min; Active Range of Motion Exercises and Foot Care Education-5 min; Treadmill- 15 min; Cycling -5 min No. Of Sessions 24, thrice a week for 8 weeks	Other: General Exercises; General Exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Berg Balance Scale	The Berg Balance Scale (BBS) is a 56-point scale that evaluates 14 tasks. Katherine Berg developed this test to assess the level of function and balance in various patient populations. Minimum score is 0 (means severe balance deficit) and Maximum score is 56 (means No balance deficit)	Baseline (Pre treatment)
Berg Balance Scale	The Berg Balance Scale (BBS) is a 56-point scale that evaluates 14 tasks. Katherine Berg developed this test to assess the level of function and balance in various patient populations. Minimum score is 0 (means severe balance deficit) and Maximum score is 56 (means No balance deficit)	At 4th week of treatment
Berg Balance Scale	The Berg Balance Scale (BBS) is a 56-point scale that evaluates 14 tasks. Katherine Berg developed this test to assess the level of function and balance in various patient populations. Minimum score is 0 (means severe balance deficit) and Maximum score is 56 (means No balance deficit)	At 8th week of treatment (Post treatment )

Collaborators and Investigators

• Sponsor: Dow University of Health Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 12, 2019
• Primary Completion (ACTUAL): September 1, 2020
• Study Completion (ACTUAL): November 1, 2020

Study Registration Dates

• First Submitted: January 11, 2020
• First Submitted That Met QC Criteria: January 15, 2020
• First Posted (ACTUAL): January 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 19, 2021
• Last Update Submitted That Met QC Criteria: August 18, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Rehabilitation; Diabetes Mellitus type 2; Diabetic neuropathy; Berg Balance Scale; Balance exercises
• Additional Relevant MeSH Terms: Nervous System Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Diabetic Neuropathies
• Other Study ID Numbers: RTazeem

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No