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Ankle Proprioceptive Training In Patients With Diabetic Peripheral Neuropathy

Primary Purpose

Diabetic Peripheral Neuropathy

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Ankle proprioceptive training (APT)
Balance training (BT)
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 focused on measuring Diabetes, Diabetic neuropathy, Balance, Risk of fall, Ankle proprioceptive training

Eligibility Criteria

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

Inclusion Criteria: Known case of diabetic peripheral neuropathy (DPN), Patients who met the criteria of DN4 scored equal or greater than 4. Patients who have positive SHARPEND ROMBERG TEST Exclusion Criteria: Patients with DVT orthostatic hypotension Any recent surgery of lower limb Amputies Patients with crutches or walking aids Patients with gangrene Lower BMI Acute systemic illness Vestibular impairment

Sites / Locations

  • Capital developmental authority hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Iinterventional group

control group

Arm Description

Ankle proprioceptive and balance training 3 days a week for 8 weeks.

Balance training 3 days a week for 8 weeks.

Outcomes

Primary Outcome Measures

Mini BESTest
Mini BESTest is a 27-item physical performance test that distributes the items among the six sub-systems of static and dynamic balance, including stability limits/verticality, biomechanical constraints, anticipatory postural adjustments, postural responses, sensory orientation and stability in gait.
Mini BESTest
Mini BESTest is a 27-item physical performance test that distributes the items among the six sub-systems of static and dynamic balance, including stability limits/verticality, biomechanical constraints, anticipatory postural adjustments, postural responses, sensory orientation and stability in gait.
Mini BESTest
Mini BESTest is a 27-item physical performance test that distributes the items among the six sub-systems of static and dynamic balance, including stability limits/verticality, biomechanical constraints, anticipatory postural adjustments, postural responses, sensory orientation and stability in gait.
Sharpened Romberg (SR)
The Sharpened Romberg (SR) has been proposed as a quick screening tool for balance. SR requires the client to stand in tandem, with the heel of one foot touching the toe of the other foot, for 30 or 60 seconds.
Sharpened Romberg (SR)
The Sharpened Romberg (SR) has been proposed as a quick screening tool for balance. SR requires the client to stand in tandem, with the heel of one foot touching the toe of the other foot, for 30 or 60 seconds.
Sharpened Romberg (SR)
The Sharpened Romberg (SR) has been proposed as a quick screening tool for balance. SR requires the client to stand in tandem, with the heel of one foot touching the toe of the other foot, for 30 or 60 seconds.
Douleur Neuropathique 4 (DN4) Questionnaire
The Douleur Neuropathique 4 (DN4) Questionnaire is a screening tool for neuropathic pain that includes physical exams and 10 interview questions (DN4-interview). As referred in its original version scores lower than 4 were defined negative and 4 or more as positive.
Douleur Neuropathique en 4 (DN4) Questionnaire
The Douleur Neuropathique 4 (DN4) Questionnaire is a screening tool for neuropathic pain that includes physical exams and 10 interview questions (DN4-interview). As referred in its original version scores lower than 4 were defined negative and 4 or more as positive.
Douleur Neuropathique en 4 (DN4) Questionnaire
The Douleur Neuropathique 4 (DN4) Questionnaire is a screening tool for neuropathic pain that includes physical exams and 10 interview questions (DN4-interview). As referred in its original version scores lower than 4 were defined negative and 4 or more as positive.
Unilateral stance test
Unilateral stance test is used for postural stability. The participant must stand unsupported on one leg. Participants are more likely to fall hurt if they can't maintain the one-leg position for at least five seconds.
Unilateral stance test
Unilateral stance test is used for postural stability. The participant must stand unsupported on one leg. Participants are more likely to fall hurt if they can't maintain the one-leg position for at least five seconds.
Unilateral stance test
Unilateral stance test is used for postural stability. The participant must stand unsupported on one leg. Participants are more likely to fall hurt if they can't maintain the one-leg position for at least five seconds.
The Falls Efficacy Scale International (FES-I)
The Falls Efficacy Scale International (FES-I) measures people's fear about falling. FES-I scores ranging from minimum 7 (no concern about falling) to maximum 28 could be used as a rapid screening tool to evaluate a person's self-reported fear of falling.
The Falls Efficacy Scale International (FES-I)
The Falls Efficacy Scale International (FES-I) measures people's fear about falling. FES-I scores ranging from minimum 7 (no concern about falling) to maximum 28 could be used as a rapid screening tool to evaluate a person's self-reported fear of falling.
The Falls Efficacy Scale International (FES-I)
The Falls Efficacy Scale International (FES-I) measures people's fear about falling. FES-I scores ranging from minimum 7 (no concern about falling) to maximum 28 could be used as a rapid screening tool to evaluate a person's self-reported fear of falling.

Secondary Outcome Measures

Full Information

First Posted
April 12, 2023
Last Updated
October 11, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05848180
Brief Title
Ankle Proprioceptive Training In Patients With Diabetic Peripheral Neuropathy
Official Title
Effect Of Ankle Proprioceptive Training On Balance And Risk Of Fall In Patients With Diabetic Peripheral Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
May 5, 2023 (Actual)
Primary Completion Date
August 30, 2023 (Actual)
Study Completion Date
September 30, 2023 (Actual)

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
Yes

5. Study Description

Brief Summary
Diabetes being a very prevalent condition results in various complications including neuropathy, which can impair various functional outcomes in patients including balance. Ankle proprioceptive training (APT) is an intervention that is used to tackle this problem. The study will compare APT with standard balance training in subjects with diabetic neuropathy.
Detailed Description
The study will include the diagnosed diabetic subjects with score of 4 or more on Douleur neuropathique 4 questionnaire (DN4Q). The subjects will be randomly divided into 2 groups; interventional group and control group. Interventional group will receive APT 3 days a week for 8 weeks. Balance training exercises will be given to both groups 3 days a week for 8 weeks. The assessments will be done at baseline, after 4 weeks and after 8 weeks of interventions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Peripheral Neuropathy
Keywords
Diabetes, Diabetic neuropathy, Balance, Risk of fall, Ankle proprioceptive training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There will be two groups .One is interventional and the other is control group. Interventional group will be taking ankle proprioceptive training and balance training, where control will be having only balance training exercises.
Masking
ParticipantOutcomes Assessor
Masking Description
The participents of both groups and the outcome assessor will be blinded
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Iinterventional group
Arm Type
Experimental
Arm Description
Ankle proprioceptive and balance training 3 days a week for 8 weeks.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Balance training 3 days a week for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Ankle proprioceptive training (APT)
Intervention Description
APT comprise of exercises including towel curls, uni-leg stance on foam with activity, writing alphabets on gym ball with toes, picking marbles with toes. BT includes tendem walk, side leg raises, sit to stand, side walk, back leg raise
Intervention Type
Other
Intervention Name(s)
Balance training (BT)
Intervention Description
Balance training exercises comprising of side walk, tandem walk, standing on one leg, walking with alternating arm raise up to 90 degrees
Primary Outcome Measure Information:
Title
Mini BESTest
Description
Mini BESTest is a 27-item physical performance test that distributes the items among the six sub-systems of static and dynamic balance, including stability limits/verticality, biomechanical constraints, anticipatory postural adjustments, postural responses, sensory orientation and stability in gait.
Time Frame
Baseline
Title
Mini BESTest
Description
Mini BESTest is a 27-item physical performance test that distributes the items among the six sub-systems of static and dynamic balance, including stability limits/verticality, biomechanical constraints, anticipatory postural adjustments, postural responses, sensory orientation and stability in gait.
Time Frame
At 4 weeks
Title
Mini BESTest
Description
Mini BESTest is a 27-item physical performance test that distributes the items among the six sub-systems of static and dynamic balance, including stability limits/verticality, biomechanical constraints, anticipatory postural adjustments, postural responses, sensory orientation and stability in gait.
Time Frame
At 8 weeks
Title
Sharpened Romberg (SR)
Description
The Sharpened Romberg (SR) has been proposed as a quick screening tool for balance. SR requires the client to stand in tandem, with the heel of one foot touching the toe of the other foot, for 30 or 60 seconds.
Time Frame
Baseline
Title
Sharpened Romberg (SR)
Description
The Sharpened Romberg (SR) has been proposed as a quick screening tool for balance. SR requires the client to stand in tandem, with the heel of one foot touching the toe of the other foot, for 30 or 60 seconds.
Time Frame
At 4 weeks
Title
Sharpened Romberg (SR)
Description
The Sharpened Romberg (SR) has been proposed as a quick screening tool for balance. SR requires the client to stand in tandem, with the heel of one foot touching the toe of the other foot, for 30 or 60 seconds.
Time Frame
At 8 weeks
Title
Douleur Neuropathique 4 (DN4) Questionnaire
Description
The Douleur Neuropathique 4 (DN4) Questionnaire is a screening tool for neuropathic pain that includes physical exams and 10 interview questions (DN4-interview). As referred in its original version scores lower than 4 were defined negative and 4 or more as positive.
Time Frame
Baseline
Title
Douleur Neuropathique en 4 (DN4) Questionnaire
Description
The Douleur Neuropathique 4 (DN4) Questionnaire is a screening tool for neuropathic pain that includes physical exams and 10 interview questions (DN4-interview). As referred in its original version scores lower than 4 were defined negative and 4 or more as positive.
Time Frame
At 4 weeks
Title
Douleur Neuropathique en 4 (DN4) Questionnaire
Description
The Douleur Neuropathique 4 (DN4) Questionnaire is a screening tool for neuropathic pain that includes physical exams and 10 interview questions (DN4-interview). As referred in its original version scores lower than 4 were defined negative and 4 or more as positive.
Time Frame
At 8 weeks
Title
Unilateral stance test
Description
Unilateral stance test is used for postural stability. The participant must stand unsupported on one leg. Participants are more likely to fall hurt if they can't maintain the one-leg position for at least five seconds.
Time Frame
Baseline
Title
Unilateral stance test
Description
Unilateral stance test is used for postural stability. The participant must stand unsupported on one leg. Participants are more likely to fall hurt if they can't maintain the one-leg position for at least five seconds.
Time Frame
At 4 weeks
Title
Unilateral stance test
Description
Unilateral stance test is used for postural stability. The participant must stand unsupported on one leg. Participants are more likely to fall hurt if they can't maintain the one-leg position for at least five seconds.
Time Frame
At 8 weeks
Title
The Falls Efficacy Scale International (FES-I)
Description
The Falls Efficacy Scale International (FES-I) measures people's fear about falling. FES-I scores ranging from minimum 7 (no concern about falling) to maximum 28 could be used as a rapid screening tool to evaluate a person's self-reported fear of falling.
Time Frame
Baseline
Title
The Falls Efficacy Scale International (FES-I)
Description
The Falls Efficacy Scale International (FES-I) measures people's fear about falling. FES-I scores ranging from minimum 7 (no concern about falling) to maximum 28 could be used as a rapid screening tool to evaluate a person's self-reported fear of falling.
Time Frame
At 4 weeks
Title
The Falls Efficacy Scale International (FES-I)
Description
The Falls Efficacy Scale International (FES-I) measures people's fear about falling. FES-I scores ranging from minimum 7 (no concern about falling) to maximum 28 could be used as a rapid screening tool to evaluate a person's self-reported fear of falling.
Time Frame
At 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Known case of diabetic peripheral neuropathy (DPN), Patients who met the criteria of DN4 scored equal or greater than 4. Patients who have positive SHARPEND ROMBERG TEST Exclusion Criteria: Patients with DVT orthostatic hypotension Any recent surgery of lower limb Amputies Patients with crutches or walking aids Patients with gangrene Lower BMI Acute systemic illness Vestibular impairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kiran Khushnood, MSNMPT
Organizational Affiliation
Riphah International University
Official's Role
Study Chair
Facility Information:
Facility Name
Capital developmental authority hospital
City
Islamabad
State/Province
Islamabad Capital Territory
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Ankle Proprioceptive Training In Patients With Diabetic Peripheral Neuropathy

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