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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed 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.

Official Title
-----------------
Influence of Physical Therapy Intervention on the Foot and Ankle in Gait Biomechanics in Individuals With Diabetic Neuropathy: a Randomized Clinical Trial

Conditions
-----------------
Diabetic Neuropathy With Loss of Sensation, Foot and Ankle Muscle Weakness, Foot and Ankle Range of Movement Restriction

Intervention / Treatment
-----------------
* Other: Physical Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical Therapy<br>Foot and ankle passive and active stretching, muscle strengthening, proprioception training and gait training. | Other: Physical Therapy<br>* strengthening passive and active stretching balance training gait training<br>|
| No Intervention: Control<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak pressure at lateral forefoot |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak pressure | In 5 foot areas: heel, midfoot, medial forefoot, hallux and toes. | 12 weeks | 
| Peak pressure | In foot areas: heel, midfoot, medial forefoot, lateral forefoot, hallux and toes. | 24 weeks | 
| Time-to-peak pressure | In 6 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux and toes. | 12 weeks | 
| Time-to-peak pressure | In 6 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux and toes. | 24 weeks | 
| Pressure-time integral | In 6 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux and toes. | 12 weeks | 
| Pressure-time integral | In 6 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux and toes. | 24 weeks | 
| Mean velocity of center of pressure displacement | In 7 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux, toes and total area. | 12 weeks | 
| Mean velocity of center or pressure displacement | In 7 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux, toes and total area. | 24 weeks | 
| Sagittal range of motion of ankle |  | 12 weeks | 
| Sagittal range of motion of ankle |  | 24 weeks | 
| Sagittal peak of extensor moment of ankle |  | 12 weeks | 
| Sagittal peak of extensor moment of ankle |  | 24 weeks | 
| Sagittal peak of flexor moment of ankle |  | 12 weeks | 
| Sagittal peak of flexor moment of ankle |  | 24 weeks | 
| Michigan Neuropathy Screening Instrument score for symptoms |  | 12 weeks | 
| Michigan Neuropathy Screening Instrument score for symptoms |  | 24 weeks | 
| Michigan Neuropathy Screening Instrument score for physical assessment |  | 12 weeks | 
| Michigan Neuropathy Screening Instrument score for physical assessment |  | 24 weeks | 
| Functional tests score |  | 12 weeks | 
| Functional tests score |  | 24 weeks | 
| Muscle function score |  | 12 weeks | 
| Muscle function score |  | 24 weeks | 
| Activities-Specific Balance Confidence Scale (ABC) |  | 12 weeks | 
| Activities-Specific Balance Confidence Scale (ABC) |  | 24 weeks |