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Completed

NCT Number: NCT01207284

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

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.

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Key information

Conditions

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

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Department of Speech, Physical Therapy and Occupational Therapy

São Paulo, 05360160, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical Therapy

Other

strengthening passive and active stretching balance training gait training

Primary outcomes

  1. Peak pressure at lateral forefoot

    Time frame: 12 weeks

Secondary outcomes

  1. Peak pressure

    Time frame: 12 weeks

    In 5 foot areas: heel, midfoot, medial forefoot, hallux and toes.

  2. Peak pressure

    Time frame: 24 weeks

    In foot areas: heel, midfoot, medial forefoot, lateral forefoot, hallux and toes.

  3. Time-to-peak pressure

    Time frame: 12 weeks

    In 6 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux and toes.

  4. Time-to-peak pressure

    Time frame: 24 weeks

    In 6 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux and toes.

  5. Pressure-time integral

    Time frame: 12 weeks

    In 6 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux and toes.

  6. Pressure-time integral

    Time frame: 24 weeks

    In 6 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux and toes.

  7. 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.

  8. 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.

  9. Sagittal range of motion of ankle

    Time frame: 12 weeks

  10. Sagittal range of motion of ankle

    Time frame: 24 weeks

  11. Sagittal peak of extensor moment of ankle

    Time frame: 12 weeks

  12. Sagittal peak of extensor moment of ankle

    Time frame: 24 weeks

  13. Sagittal peak of flexor moment of ankle

    Time frame: 12 weeks

  14. Sagittal peak of flexor moment of ankle

    Time frame: 24 weeks

  15. Michigan Neuropathy Screening Instrument score for symptoms

    Time frame: 12 weeks

  16. Michigan Neuropathy Screening Instrument score for symptoms

    Time frame: 24 weeks

  17. Michigan Neuropathy Screening Instrument score for physical assessment

    Time frame: 12 weeks

  18. Michigan Neuropathy Screening Instrument score for physical assessment

    Time frame: 24 weeks

  19. Functional tests score

    Time frame: 12 weeks

  20. Functional tests score

    Time frame: 24 weeks

  21. Muscle function score

    Time frame: 12 weeks

  22. Muscle function score

    Time frame: 24 weeks

  23. Activities-Specific Balance Confidence Scale (ABC)

    Time frame: 12 weeks

  24. Activities-Specific Balance Confidence Scale (ABC)

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Sep 22, 2010
Registry last updated
Sep 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.