NCT04232995

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 12, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

August 19, 2021

Status Verified

August 1, 2021

Enrollment Period

1.5 years

First QC Date

January 11, 2020

Last Update Submit

August 18, 2021

Conditions

Diabetic Neuropathy With Neurologic Complication

Keywords

Diabetes Mellitus type 2Diabetic neuropathyRehabilitationBalance exercisesBerg Balance Scale

Outcome Measures

Primary Outcomes (3)

  • 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 )

Study Arms (2)

Experimental Group

EXPERIMENTAL

Balance training by 9 positions with 1 min hold, repeated twice 1. Stand with feet together, eyes remain open 2. Stand with together, eyes closed 3. \& 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 TrainingOther: General Exercises

Control Group

ACTIVE COMPARATOR

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

Interventions

Balance TrainingOTHER

Balance enhancing exercises

Experimental Group
General ExercisesOTHER

General Exercises

Control GroupExperimental Group

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Karachi, Sindh, 74200, Pakistan

Location

MeSH Terms

Conditions

Diabetic NeuropathiesDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 11, 2020

First Posted

January 18, 2020

Study Start

March 12, 2019

Primary Completion

September 1, 2020

Study Completion

November 1, 2020

Last Updated

August 19, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)