Influence of Physical Therapy for Foot and Ankle in the Gait of Individuals With Diabetic Neuropathy
- Conditions
- Diabetic Neuropathy With Loss of SensationFoot and Ankle Muscle WeaknessFoot and Ankle Range of Movement Restriction
- Interventions
- Other: Physical Therapy
- Registration Number
- NCT01207284
- Lead Sponsor
- University of Sao Paulo General Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Physical Therapy Physical Therapy Foot and ankle passive and active stretching, muscle strengthening, proprioception training and gait training.
- Primary Outcome Measures
Name Time Method Peak pressure at lateral forefoot 12 weeks
- Secondary Outcome Measures
Name Time Method Peak pressure 24 weeks In foot areas: heel, midfoot, medial forefoot, lateral forefoot, hallux and toes.
Sagittal peak of extensor moment of ankle 24 weeks Sagittal peak of flexor moment of ankle 24 weeks Michigan Neuropathy Screening Instrument score for symptoms 24 weeks Michigan Neuropathy Screening Instrument score for physical assessment 24 weeks Time-to-peak pressure 24 weeks In 6 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux and toes.
Pressure-time integral 24 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 24 weeks Functional tests score 24 weeks Muscle function score 24 weeks Activities-Specific Balance Confidence Scale (ABC) 24 weeks
Trial Locations
- Locations (1)
Department of Speech, Physical Therapy and Occupational Therapy
🇧🇷Sao Paulo, Brazil