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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01207284
First received: September 20, 2010
Last updated: March 26, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetic Neuropathy With Loss of Sensation
Foot and Ankle Muscle Weakness
Foot and Ankle Range of Movement Restriction
 Other: Physical Therapy
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of Physical Therapy Intervention on the Foot and Ankle in Gait Biomechanics in Individuals With Diabetic Neuropathy: a Randomized Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • plantar pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • lower limbs kinematics [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • follow up period [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Concearning plantar pressure and kinematic outcomes.


Estimated Enrollment: 40
Study Start Date: August 2010
Estimated Study Completion Date: June 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Physical Therapy
Foot and ankle passive and active stretching, muscle strengthening and proprioception training.
 Other: Physical Therapy

Strengthening Exercises

Stretching Exercises

Other Names:
  • Strength Exercise
  • Flexibility Exercises
Active Comparator: standard
Treatment that the medical group prescribes normally, including medication, special shoes and self care.
 Other: Physical Therapy

Strengthening Exercises

Stretching Exercises

Other Names:
  • Strength Exercise
  • Flexibility Exercises

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.

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diabetic neuropathy clinically diagnosed by the medical group
  • BMI between 18,5 e 29,9 kg/m2
  • loss of tactile and/or vibratory sensation
  • foot and/or ankle muscle weakness
  • foot and/or ankle range of movement restriction

Exclusion Criteria:

  • previous or actual ulceration
  • severe macroangiopathy
  • severe ocular impairments
  • history of stroke
  • other orthopaedic or neurologic impairments that compromise independent gait
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01207284

Locations
Brazil
Department of Speech, Physical Therapy and Occupational Therapy
Sao Paulo, Brazil, 05360160
Sponsors and Collaborators
University of Sao Paulo General Hospital
Fundação de Amparo à Pesquisa do Estado de São Paulo
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Study Chair: Isabel CN Sacco University of Sao Paulo
  More Information

No publications provided by University of Sao Paulo General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01207284     History of Changes
Other Study ID Numbers: LaBiMPH-001
Study First Received: September 20, 2010
Last Updated: March 26, 2013
Health Authority: Brazil: Ethics Committee

Additional relevant MeSH terms:
Diabetic Neuropathies
Muscle Weakness
Paresis
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
 Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Pathologic Processes
Signs and Symptoms
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on May 22, 2013