Clinical trial NCT05848180: Ankle Proprioceptive Training In Patients With Diabetic Peripheral Neuropathy
Official title: Effect Of Ankle Proprioceptive Training On Balance And Risk Of Fall In Patients With Diabetic Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Peripheral Neuropathy
Keywords: Diabetes
Diabetic neuropathy
Balance
Risk of fall
Ankle proprioceptive training
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-05-08
Enrollment: 62
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mini BESTest
timeFrame: Baseline
measure: Mini BESTest
timeFrame: At 4 weeks
measure: Mini BESTest
timeFrame: At 8 weeks
measure: Sharpened Romberg (SR)
timeFrame: Baseline
measure: Sharpened Romberg (SR)
timeFrame: At 4 weeks
measure: Sharpened Romberg (SR)
timeFrame: At 8 weeks
measure: Douleur Neuropathique 4 (DN4) Questionnaire
timeFrame: Baseline
measure: Douleur Neuropathique en 4 (DN4) Questionnaire
timeFrame: At 4 weeks
measure: Douleur Neuropathique en 4 (DN4) Questionnaire
timeFrame: At 8 weeks
measure: Unilateral stance test
timeFrame: Baseline
measure: Unilateral stance test
timeFrame: At 4 weeks
measure: Unilateral stance test
timeFrame: At 8 weeks
measure: The Falls Efficacy Scale International (FES-I)
timeFrame: Baseline
measure: The Falls Efficacy Scale International (FES-I)
timeFrame: At 4 weeks
measure: The Falls Efficacy Scale International (FES-I)
timeFrame: At 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Capital developmental authority hospital
state: Islamabad Capital Territory
Study officials:
affiliation: Riphah International University
name: Kiran Khushnood, MSNMPT
role: STUDY_CHAIR
References: