Diabetic Neuropathy With Loss of Sensation Clinical Trial
Official title:
Influence of Physical Therapy Intervention on the Foot and Ankle in Gait Biomechanics in Individuals With Diabetic Neuropathy: a Randomized Clinical Trial
| Verified date | September 2013 |
| Source | University of Sao Paulo General Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Brazil: Ethics Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 55 |
| Est. completion date | June 2013 |
| Est. primary completion date | October 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 45 Years to 65 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Department of Speech, Physical Therapy and Occupational Therapy | Sao Paulo |
| Lead Sponsor | Collaborator |
|---|---|
| University of Sao Paulo General Hospital | 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 |
Brazil,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Peak pressure at lateral forefoot | 12 weeks | No | |
| Secondary | Peak pressure | In 5 foot areas: heel, midfoot, medial forefoot, hallux and toes. | 12 weeks | No |
| Secondary | Peak pressure | In foot areas: heel, midfoot, medial forefoot, lateral forefoot, hallux and toes. | 24 weeks | No |
| Secondary | Time-to-peak pressure | In 6 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux and toes. | 12 weeks | No |
| Secondary | Time-to-peak pressure | In 6 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux and toes. | 24 weeks | No |
| Secondary | Pressure-time integral | In 6 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux and toes. | 12 weeks | No |
| Secondary | Pressure-time integral | In 6 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux and toes. | 24 weeks | No |
| Secondary | Mean velocity of center of pressure displacement | In 7 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux, toes and total area. | 12 weeks | No |
| Secondary | Mean velocity of center or pressure displacement | In 7 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux, toes and total area. | 24 weeks | No |
| Secondary | Sagittal range of motion of ankle | 12 weeks | No | |
| Secondary | Sagittal range of motion of ankle | 24 weeks | No | |
| Secondary | Sagittal peak of extensor moment of ankle | 12 weeks | No | |
| Secondary | Sagittal peak of extensor moment of ankle | 24 weeks | No | |
| Secondary | Sagittal peak of flexor moment of ankle | 12 weeks | No | |
| Secondary | Sagittal peak of flexor moment of ankle | 24 weeks | No | |
| Secondary | Michigan Neuropathy Screening Instrument score for symptoms | 12 weeks | No | |
| Secondary | Michigan Neuropathy Screening Instrument score for symptoms | 24 weeks | No | |
| Secondary | Michigan Neuropathy Screening Instrument score for physical assessment | 12 weeks | No | |
| Secondary | Michigan Neuropathy Screening Instrument score for physical assessment | 24 weeks | No | |
| Secondary | Functional tests score | 12 weeks | No | |
| Secondary | Functional tests score | 24 weeks | No | |
| Secondary | Muscle function score | 12 weeks | No | |
| Secondary | Muscle function score | 24 weeks | No | |
| Secondary | Activities-Specific Balance Confidence Scale (ABC) | 12 weeks | No | |
| Secondary | Activities-Specific Balance Confidence Scale (ABC) | 24 weeks | No |