About this trial
The aim of this study is to determine the comparative effects of plantar intrinsic muscles exercises and three-dimensional ankle foot exercises on balance, gait and fall risk in patients with diabetic peripheral neuropathy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The participants who scored ≥ 7 (abnormal) as per the Michigan Neuropathy Screening Instrument (MNSI)
Able to ambulate 10 m barefoot without using a walking aid
Patient reporting to have either fear of falling or experienced a fall in the previous 12 months
Cognitive Function on Mini-Mental State Examination is normal (MMSE score: Above 25)
Disqualifiers
Presence of other neurological conditions (GBS, Paraneoplastic Neuropathy, Infectious Neuropathy, others)
Severe Retinopathy, a vascular complication of DM.
Limited Ankle and foot ROM due to fracture or contracture.
Presence of active plantar ulcers.
Trial design
Parallel
Treatments tested in this trial
Plantar intrinsic foot exercises
Other interventionPlantar Intrinsic Foot Exercises (PIFE), for 40 minutes, thrice a week for 8 weeks. Warm-up, conventional therapy, and cool-down will be given.
Three-Dimensional ankle foot exercises
Other intervention3D Ankle-Foot Exercises (3D-AFE), for 40 minutes, thrice a week for 8 weeks. Warm-up, conventional therapy, and cool-down will be given.
Treatment groups
Trial outcomes
Primary outcomes
Tinetti Performance Oriented Mobility Assessment (POMA)
Changes from baseline Tinetti Performance Oriented Mobility Assessment (POMA) is clinical instrument for assessing balance and gait function in patients with neurological or musculoskeletal disorders as well as older patients. Scores of 25-28 indicate low fall risk, 19-24 medium fall risk, and \< 19 high fall risk.
Secondary outcomes
Michigan Neuropathy Screening Instrument (MNSI)
Changes from baseline, the Michigan Neuropathy Screening Instrument (MNSI) is designed to screen for the presence of diabetic neuropathy. The first part of the screening instrument consists of 15 self-administered questions on foot sensation including pain, numbness and temperature sensitivity. The second part of the MNSI is a brief physical examination involving 1) inspection of the feet for deformities, dry skin, hair or nail abnormalities, callous or infection, (2) semi-quantitative assessment of vibration sensation at the dorsum of the great toe, (3) grading of ankle reflexes and, (4) monofilament testing.
Sponsors and contacts
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