Status:
COMPLETED
Influence of Physical Therapy for Foot and Ankle in the Gait of Individuals With Diabetic Neuropathy
Lead Sponsor:
University of Sao Paulo General Hospital
Collaborating Sponsors:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Conditions:
Diabetic Neuropathy With Loss of Sensation
Foot and Ankle Muscle Weakness
Eligibility:
All Genders
45-65 years
Phase:
PHASE1
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...
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 d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT01207284
Start Date
August 1 2010
End Date
June 1 2013
Last Update
September 27 2013
Active Locations (1)
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1
Department of Speech, Physical Therapy and Occupational Therapy
São Paulo, São Paulo, Brazil, 05360160