Ankle Proprioceptive Training In Patients With Diabetic Peripheral Neuropathy

Effect Of Ankle Proprioceptive Training On Balance And Risk Of Fall In Patients With Diabetic Peripheral Neuropathy

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Peripheral Neuropathy
• Intervention / Treatment: Other: Ankle proprioceptive training (APT); Other: Balance training (BT)

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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Islamabad Capital Territory
    • Islamabad, Islamabad Capital Territory, Pakistan, 44000
      • Capital developmental authority hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Iinterventional group; Ankle proprioceptive and balance training 3 days a week for 8 weeks.	Other: Ankle proprioceptive training (APT); 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; Other: Balance training (BT); Balance training exercises comprising of side walk, tandem walk, standing on one leg, walking with alternating arm raise up to 90 degrees
Active Comparator: control group; Balance training 3 days a week for 8 weeks.	Other: Balance training (BT); Balance training exercises comprising of side walk, tandem walk, standing on one leg, walking with alternating arm raise up to 90 degrees

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline
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.	At 4 weeks
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.	At 8 weeks
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.	Baseline
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.	At 4 weeks
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.	At 8 weeks
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.	Baseline
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.	At 4 weeks
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.	At 8 weeks
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.	Baseline
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.	At 4 weeks
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.	At 8 weeks
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.	Baseline
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.	At 4 weeks
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.	At 8 weeks

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Study Chair: Kiran Khushnood, MSNMPT, Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2023
• Primary Completion (Actual): August 30, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: April 12, 2023
• First Submitted That Met QC Criteria: May 4, 2023
• First Posted (Actual): May 8, 2023

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Diabetes; Balance; Diabetic neuropathy; Risk of fall; Ankle proprioceptive training
• 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: RIPHAH/FR&AHS/Letter-014124

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