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Ankle Proprioceptive Training In Patients With Diabetic Peripheral Neuropathy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05848180
Enrollment
62
Registered
2023-05-08
Start date
2023-05-05
Completion date
2023-09-30
Last updated
2023-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Peripheral Neuropathy

Keywords

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

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.

Interventions

OTHERAnkle 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

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

Sponsors

Riphah International University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

The participents of both groups and the outcome assessor will be blinded

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.

Eligibility

Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mini BESTestBaselineMini 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)BaselineThe 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 4 (DN4) QuestionnaireBaselineThe 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.
Douleur Neuropathique en 4 (DN4) QuestionnaireAt 4 weeksThe 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 testBaselineUnilateral 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.
The Falls Efficacy Scale International (FES-I)BaselineThe 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.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026