Diabetic Peripheral Neuropathy (DPN)
Conditions
Keywords
Diabetic peripheral neuropathy, balance, gait, Plantar intrinsic muscle exercises, Three-Dimensional ankle foot exercises
Brief summary
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.
Detailed description
Diabetic Peripheral Neuropathy (DPN) is among the most common and disabling complications of diabetes mellitus, affecting up to 50% of long-term diabetic patients. Patients commonly present with symmetrical sensory loss (distal extremities), paresthesia, muscle weakness and atrophy (particularly of intrinsic foot musculature), impaired proprioception and vibration sense. Plantar intrinsic muscles exercises target the tiny, stabilizing muscles within the foot particularly, improving intrinsic support and arch integrity, whereas three-dimensional ankle foot exercises place an emphasis on multidirectional motions that increase joint mobility, neuromuscular coordination, and general lower limb strength. The aim of this study is to determine 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. This study will be a single-blinded randomized clinical trial. Non probability convenience sampling will be used to recruit 40 patients of either gender, aged 50-75 years, and diagnosed with Diabetic peripheral neuropathy (DPN). This study will be carried out in Dr. Faisal Masood Teaching Hospital, Sargodha. These participants will be randomly allocated to Group A and Group B through computerized table generator method. Group A will receive plantar intrinsic muscle exercises, whereas group B will receive three-dimensional ankle foot exercises. Both groups will perform their respective exercises 40 minutes, thrice a week for 8 weeks. The participants will be evaluated at the start and end of the exercise program through Michigan Neuropathy Screening Instrument (MNSI) and Tinetti Performance Oriented Mobility Assessment (POMA) to assess the effect of this intervention on balance, gait and fall risk. Data will be analyzed by SPSS version 27.
Interventions
OTHERPlantar intrinsic foot exercises
Plantar Intrinsic Foot Exercises (PIFE), for 40 minutes, thrice a week for 8 weeks. Warm-up, conventional therapy, and cool-down will be given.
OTHERThree-Dimensional ankle foot exercises
3D Ankle-Foot Exercises (3D-AFE), for 40 minutes, thrice a week for 8 weeks. Warm-up, conventional therapy, and cool-down will be given.
Sponsors
Riphah International University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Randomized for RCT
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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) * Patients having difficulties with mobility, gait, or balance in daily life
Exclusion criteria
* 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. * Recent surgeries or injuries in the foot/lower limb. * Musculoskeletal disorders affecting gait (Osteoarthritis, Rheumatoid arthritis, Muscular dystrophy, Hip dysplasia, others) * Participation in another rehabilitation or training concurrently
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tinetti Performance Oriented Mobility Assessment (POMA) | 8th week | 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
| Measure | Time frame | Description |
|---|---|---|
| Michigan Neuropathy Screening Instrument (MNSI) | 8th week | 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. |
Countries
Pakistan
Contacts
CONTACTImran Amjad, Phd
PRINCIPAL_INVESTIGATORHira Jabeen, MS-PT
Riphah International University
PRINCIPAL_INVESTIGATORHira Jabeen
Riphah International University
Outcome results
None listed