Plantar Intrinsic Muscles Exercises and Three-dimensional Ankle Foot Exercises Comparative Effect in DPN

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-75
SponsorRiphah International University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Plantar intrinsic foot exercises

    Other intervention

    Plantar 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 intervention

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Plantar intrinsic muscle exercisesActive comparator 1 intervention
Group B: Three-Dimensional ankle foot exercisesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
8th week

Secondary outcomes

1

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.

Time frame
8th week

Other outcomes

Sponsors and contacts

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