Influence of Physical Therapy for Foot and Ankle in the Gait of Individuals With Diabetic Neuropathy

University of Sao Paulo General Hospital

Status and phase: Completed; Phase 1

Conditions: Foot and Ankle Range of Movement Restriction; Foot and Ankle Muscle Weakness; Diabetic Neuropathy With Loss of Sensation

Treatments: Other: Physical Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01207284

LaBiMPH-001

Details and patient eligibility

About

The hypothesis is that a physical therapy intervention for foot and ankle of diabetic neuropathic individuals would affect positively the way they walk, lowering the harmful forces that these segments receive, that are associated mainly with lower range of movement, muscle weakness and loss of sensation. The participants will be randomly assigned into control group (regular treatment prescribed by their medical group) or into treatment group, that will receive 12 weeks of physical therapy intervention, twice a week, for 45 minutes each session. This will aim for increasing foot and ankle range of movement, muscle strength and improving sensory inputs.

Full description

In this study, were included subjects diagnosed with diabetic neuropathy, aged between 45 and 65 years old. We aimed to assess the effect of a physical therapy program on biomechanics of lower limbs during gait.

Enrollment: 55 patients

Sex: All

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diabetes mellitus type 1 or 2 diagnosed for at least seven years
• body mass index ranging 18.5-29.9 kg/m2 (normal and overweight classifications)
• diabetic polyneuropathy diagnosed by the medical care center: score higher than 2 out of 13 in the Michigan Neuropathy Screening Instrument (MNSI) questionnaire, indicating the presence of at least two diabetic polyneuropathy symptoms; score higher than 1 out of 10 for physical assessment of the MNSI instrument, but always including impaired vibration perception
• ability to walk independently in the laboratory

Exclusion criteria

• ulceration not healed for at least 6 months
• partial or total foot amputation
• receiving any physiotherapy intervention or offloading devices
• neurological or orthopedic impairments
• major vascular complications
• severe retinopathy
• severe nephropathy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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55 participants in 2 patient groups

Physical Therapy

Experimental group

Description:

Foot and ankle passive and active stretching, muscle strengthening, proprioception training and gait training.

Treatment:

Other: Physical Therapy

Control

No Intervention group