Ankle Proprioceptive Training In Patients With Diabetic Peripheral Neuropathy

NCT05848180 | Completed DMC

• 1 other identifier: RIPHAH/FR&AHS/Letter-014124
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Peripheral Neuropathy

Keywords

Diabetes; Diabetic neuropathy; Balance; Risk of fall; Ankle proprioceptive training

Outcome Measures

Primary Outcomes (15)

• 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

Study Arms (2)

Iinterventional group

EXPERIMENTAL

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

Other: Ankle proprioceptive training (APT); Other: Balance training (BT)

control group

ACTIVE COMPARATOR

Balance training 3 days a week for 8 weeks.

Other: Balance training (BT)

Interventions

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

Iinterventional group

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

Iinterventional group; control group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Capital developmental authority hospital

Islamabad, Islamabad, 44000, Pakistan

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications

Study Officials

• Kiran Khushnood, MSNMPT

  Riphah International University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participents of both groups and the outcome assessor will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: May 8, 2023
• Study Start: May 5, 2023
• Primary Completion: August 30, 2023
• Study Completion: September 30, 2023
• Last Updated: October 12, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)