Diabetic Neuropathy With Loss of Sensation, Foot and Ankle Muscle Weakness, Foot and Ankle Range of Movement Restriction
Conditions
Brief summary
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.
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.
Interventions
OTHERPhysical Therapy
strengthening passive and active stretching balance training gait training
Sponsors
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
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak pressure at lateral forefoot | 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time-to-peak pressure | 12 weeks | In 6 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux and toes. |
| Pressure-time integral | 12 weeks | In 6 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux and toes. |
| Mean velocity of center of pressure displacement | 12 weeks | In 7 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux, toes and total area. |
| Mean velocity of center or pressure displacement | 24 weeks | In 7 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux, toes and total area. |
| Sagittal range of motion of ankle | 12 weeks | — |
| Sagittal peak of extensor moment of ankle | 12 weeks | — |
| Peak pressure | 12 weeks | In 5 foot areas: heel, midfoot, medial forefoot, hallux and toes. |
| Michigan Neuropathy Screening Instrument score for symptoms | 12 weeks | — |
| Michigan Neuropathy Screening Instrument score for physical assessment | 12 weeks | — |
| Functional tests score | 12 weeks | — |
| Muscle function score | 12 weeks | — |
| Activities-Specific Balance Confidence Scale (ABC) | 12 weeks | — |
| Sagittal peak of flexor moment of ankle | 12 weeks | — |
Countries
Brazil
Outcome results
None listed