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Completed

NCT Number: NCT05848180

Ankle Proprioceptive Training 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.

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Key information

Conditions

Diabetic Peripheral Neuropathy Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Peripheral Nervous System Diseases

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Capital developmental authority hospital

Islamabad, 44000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ankle proprioceptive training (APT)

Other

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

Balance Training (BT)

Other

Balance training exercises comprising of side walk, tandem walk, standing on one leg, walking with alternating arm raise up to 90 degrees

Primary outcomes

  1. Mini BESTest

    Time frame: Baseline

    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.

  2. Mini BESTest

    Time frame: At 4 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.

  3. 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.

  4. Sharpened Romberg (SR)

    Time frame: Baseline

    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.

  5. Sharpened Romberg (SR)

    Time frame: At 4 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.

  6. 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.

  7. 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.

  8. Douleur Neuropathique en 4 (DN4) Questionnaire

    Time frame: At 4 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.

  9. 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.

  10. Unilateral stance test

    Time frame: Baseline

    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.

  11. Unilateral stance test

    Time frame: At 4 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.

  12. 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.

  13. The Falls Efficacy Scale International (FES-I)

    Time frame: Baseline

    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.

  14. The Falls Efficacy Scale International (FES-I)

    Time frame: At 4 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.

  15. 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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 8, 2023
Registry last updated
Oct 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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