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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01207284
First Posted: September 22, 2010
Last Update Posted: September 27, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
September 20, 2010
September 22, 2010
September 27, 2013
August 2010
October 2012   (Final data collection date for primary outcome measure)
Peak pressure at lateral forefoot [ Time Frame: 12 weeks ]
plantar pressure [ Time Frame: 12 weeks ]
Complete list of historical versions of study NCT01207284 on ClinicalTrials.gov Archive Site
  • Peak pressure [ Time Frame: 12 weeks ]
    In 5 foot areas: heel, midfoot, medial forefoot, hallux and toes.
  • Peak pressure [ Time Frame: 24 weeks ]
    In foot areas: heel, midfoot, medial forefoot, lateral forefoot, hallux and toes.
  • Time-to-peak pressure [ Time Frame: 12 weeks ]
    In 6 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux and toes.
  • Time-to-peak pressure [ Time Frame: 24 weeks ]
    In 6 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux and toes.
  • Pressure-time integral [ Time Frame: 12 weeks ]
    In 6 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux and toes.
  • Pressure-time integral [ Time Frame: 24 weeks ]
    In 6 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux and toes.
  • Mean velocity of center of pressure displacement [ Time Frame: 12 weeks ]
    In 7 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux, toes and total area.
  • Mean velocity of center or pressure displacement [ Time Frame: 24 weeks ]
    In 7 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux, toes and total area.
  • Sagittal range of motion of ankle [ Time Frame: 12 weeks ]
  • Sagittal range of motion of ankle [ Time Frame: 24 weeks ]
  • Sagittal peak of extensor moment of ankle [ Time Frame: 12 weeks ]
  • Sagittal peak of extensor moment of ankle [ Time Frame: 24 weeks ]
  • Sagittal peak of flexor moment of ankle [ Time Frame: 12 weeks ]
  • Sagittal peak of flexor moment of ankle [ Time Frame: 24 weeks ]
  • Michigan Neuropathy Screening Instrument score for symptoms [ Time Frame: 12 weeks ]
  • Michigan Neuropathy Screening Instrument score for symptoms [ Time Frame: 24 weeks ]
  • Michigan Neuropathy Screening Instrument score for physical assessment [ Time Frame: 12 weeks ]
  • Michigan Neuropathy Screening Instrument score for physical assessment [ Time Frame: 24 weeks ]
  • Functional tests score [ Time Frame: 12 weeks ]
  • Functional tests score [ Time Frame: 24 weeks ]
  • Muscle function score [ Time Frame: 12 weeks ]
  • Muscle function score [ Time Frame: 24 weeks ]
  • Activities-Specific Balance Confidence Scale (ABC) [ Time Frame: 12 weeks ]
  • Activities-Specific Balance Confidence Scale (ABC) [ Time Frame: 24 weeks ]
  • lower limbs kinematics [ Time Frame: 12 weeks ]
  • follow up period [ Time Frame: 12 weeks ]
    Concearning plantar pressure and kinematic outcomes.
Not Provided
Not Provided
 
Influence of Physical Therapy for Foot and Ankle in the Gait of Individuals With Diabetic Neuropathy
Influence of Physical Therapy Intervention on the Foot and Ankle in Gait Biomechanics in Individuals With Diabetic Neuropathy: a Randomized Clinical Trial
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.
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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Diabetic Neuropathy With Loss of Sensation
  • Foot and Ankle Muscle Weakness
  • Foot and Ankle Range of Movement Restriction
Other: Physical Therapy
strengthening passive and active stretching balance training gait training
  • Experimental: Physical Therapy
    Foot and ankle passive and active stretching, muscle strengthening, proprioception training and gait training.
    Intervention: Other: Physical Therapy
  • No Intervention: Control

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
June 2013
October 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
45 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT01207284
LaBiMPH-001
No
Not Provided
Not Provided
University of Sao Paulo General Hospital
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
Study Chair: Isabel CN Sacco University of Sao Paulo
University of Sao Paulo General Hospital
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP