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Clinical Trials/NCT05848180
NCT05848180
Completed
N/A

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

Riphah International University1 site in 1 country62 target enrollmentMay 5, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Diabetic Peripheral Neuropathy
Sponsor
Riphah International University
Enrollment
62
Locations
1
Primary Endpoint
Mini BESTest
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 5, 2023
End Date
September 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Known case of diabetic peripheral neuropathy (DPN),
  • Patients who met the criteria of DN4 scored equal or greater than
  • Patients who have positive SHARPEND ROMBERG TEST

Exclusion Criteria

  • Patients with DVT
  • orthostatic hypotension
  • Any recent surgery of lower limb
  • Patients with crutches or walking aids
  • Patients with gangrene
  • Lower BMI
  • Acute systemic illness
  • Vestibular impairment

Outcomes

Primary Outcomes

Mini BESTest

Time Frame: At 8 weeks

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)

Time Frame: At 8 weeks

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 en 4 (DN4) Questionnaire

Time Frame: At 8 weeks

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

Time Frame: At 8 weeks

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.

Douleur Neuropathique 4 (DN4) Questionnaire

Time Frame: Baseline

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.

The Falls Efficacy Scale International (FES-I)

Time Frame: At 8 weeks

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.

Study Sites (1)

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