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Ankle Proprioceptive Training In Patients With Diabetic Peripheral Neuropathy

Not Applicable
Completed
Conditions
Diabetic Peripheral Neuropathy
Interventions
Other: Ankle proprioceptive training (APT)
Other: Balance training (BT)
Registration Number
NCT05848180
Lead Sponsor
Riphah International University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
62
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Iinterventional groupAnkle proprioceptive training (APT)Ankle proprioceptive and balance training 3 days a week for 8 weeks.
control groupBalance training (BT)Balance training 3 days a week for 8 weeks.
Iinterventional groupBalance training (BT)Ankle proprioceptive and balance training 3 days a week for 8 weeks.
Primary Outcome Measures
NameTimeMethod
Mini BESTestAt 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)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) QuestionnaireAt 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 testAt 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) QuestionnaireBaseline

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)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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Capital developmental authority hospital

🇵🇰

Islamabad, Islamabad Capital Territory, Pakistan

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