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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:
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: September 26, 2013
Last verified: September 2013
  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:


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

Primary Outcome Measures:
  • Peak pressure at lateral forefoot [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Peak pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    In 5 foot areas: heel, midfoot, medial forefoot, hallux and toes.

  • Peak pressure [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    In foot areas: heel, midfoot, medial forefoot, lateral forefoot, hallux and toes.

  • Time-to-peak pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    In 6 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux and toes.

  • Time-to-peak pressure [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    In 6 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux and toes.

  • Pressure-time integral [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    In 6 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux and toes.

  • Pressure-time integral [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    In 6 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux and toes.

  • Mean velocity of center of pressure displacement [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Sagittal range of motion of ankle [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Sagittal peak of extensor moment of ankle [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Sagittal peak of extensor moment of ankle [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Sagittal peak of flexor moment of ankle [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Sagittal peak of flexor moment of ankle [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Michigan Neuropathy Screening Instrument score for symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Michigan Neuropathy Screening Instrument score for symptoms [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Michigan Neuropathy Screening Instrument score for physical assessment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Michigan Neuropathy Screening Instrument score for physical assessment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Functional tests score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Functional tests score [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Muscle function score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Muscle function score [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Activities-Specific Balance Confidence Scale (ABC) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Activities-Specific Balance Confidence Scale (ABC) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: August 2010
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, proprioception training and gait training.
Other: Physical Therapy
strengthening passive and active stretching balance training gait training
No Intervention: Control

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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: September 26, 2013
Health Authority: Brazil: Ethics Committee

Additional relevant MeSH terms:
Diabetic Neuropathies
Muscle Weakness
Paresis
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Neuromuscular Manifestations
Pathologic Processes
Peripheral Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014