Ankle Proprioceptive Training In Patients With Diabetic Peripheral Neuropathy

NCT ID: NCT05848180

Last Updated: 2023-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-05
• Study Completion Date: 2023-09-30

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.

Conditions

Diabetic Peripheral Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Iinterventional group

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

Group Type: EXPERIMENTAL

Ankle proprioceptive training (APT)

Intervention Type: 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)

Intervention Type: OTHER

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

control group

Balance training 3 days a week for 8 weeks.

Group Type: ACTIVE_COMPARATOR

Balance training (BT)

Intervention Type: OTHER

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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kiran Khushnood, MSNMPT

Role: STUDY_CHAIR

Riphah International University

Locations

Capital developmental authority hospital

Islamabad, Islamabad, Pakistan

Countries

Pakistan

Other Identifiers

RIPHAH/FR&AHS/Letter-014124

Identifier Type: -

Identifier Source: org_study_id