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Balance Training in Diabetic Neuropathy

Primary Purpose

Diabetic Neuropathy With Neurologic Complication

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Balance Training
General Exercises
Sponsored by
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Neuropathy With Neurologic Complication focused on measuring Diabetes Mellitus type 2, Diabetic neuropathy, Rehabilitation, Balance exercises, Berg Balance Scale

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Physical Medicine and Rehabilitation, Dow University of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)
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)
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)

Secondary Outcome Measures

Full Information

First Posted
January 11, 2020
Last Updated
August 18, 2021
Sponsor
Dow University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04232995
Brief Title
Balance Training in Diabetic Neuropathy
Official Title
Efficacy of Balance Training in Comparison to General Exercises Alone in Diabetic Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
March 12, 2019 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
November 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathy With Neurologic Complication
Keywords
Diabetes Mellitus type 2, Diabetic neuropathy, Rehabilitation, Balance exercises, Berg Balance Scale

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Balance Training
Intervention Description
Balance enhancing exercises
Intervention Type
Other
Intervention Name(s)
General Exercises
Intervention Description
General Exercises
Primary Outcome Measure Information:
Title
Berg Balance Scale
Description
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)
Time Frame
Baseline (Pre treatment)
Title
Berg Balance Scale
Description
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)
Time Frame
At 4th week of treatment
Title
Berg Balance Scale
Description
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)
Time Frame
At 8th week of treatment (Post treatment )

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Institute of Physical Medicine and Rehabilitation, Dow University of Health Sciences
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74200
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Balance Training in Diabetic Neuropathy

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