Clinical trial NCT01207284: Influence of Physical Therapy for Foot and Ankle in the Gait of Individuals With Diabetic Neuropathy
Official title: Influence of Physical Therapy Intervention on the Foot and Ankle in Gait Biomechanics in Individuals With Diabetic Neuropathy: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetic Neuropathy With Loss of Sensation
Foot and Ankle Muscle Weakness
Foot and Ankle Range of Movement Restriction
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2010-09-22
Enrollment: 55
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Peak pressure at lateral forefoot
timeFrame: 12 weeks
Secondary outcomes:
measure: Peak pressure
timeFrame: 12 weeks
measure: Peak pressure
timeFrame: 24 weeks
measure: Time-to-peak pressure
timeFrame: 12 weeks
measure: Time-to-peak pressure
timeFrame: 24 weeks
measure: Pressure-time integral
timeFrame: 12 weeks
measure: Pressure-time integral
timeFrame: 24 weeks
measure: Mean velocity of center of pressure displacement
timeFrame: 12 weeks
measure: Mean velocity of center or pressure displacement
timeFrame: 24 weeks
measure: Sagittal range of motion of ankle
timeFrame: 12 weeks
measure: Sagittal range of motion of ankle
timeFrame: 24 weeks
measure: Sagittal peak of extensor moment of ankle
timeFrame: 12 weeks
measure: Sagittal peak of extensor moment of ankle
timeFrame: 24 weeks
measure: Sagittal peak of flexor moment of ankle
timeFrame: 12 weeks
measure: Sagittal peak of flexor moment of ankle
timeFrame: 24 weeks
measure: Michigan Neuropathy Screening Instrument score for symptoms
timeFrame: 12 weeks
measure: Michigan Neuropathy Screening Instrument score for symptoms
timeFrame: 24 weeks
measure: Michigan Neuropathy Screening Instrument score for physical assessment
timeFrame: 12 weeks
measure: Michigan Neuropathy Screening Instrument score for physical assessment
timeFrame: 24 weeks
measure: Functional tests score
timeFrame: 12 weeks
measure: Functional tests score
timeFrame: 24 weeks
measure: Muscle function score
timeFrame: 12 weeks
measure: Muscle function score
timeFrame: 24 weeks
measure: Activities-Specific Balance Confidence Scale (ABC)
timeFrame: 12 weeks
measure: Activities-Specific Balance Confidence Scale (ABC)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Department of Speech, Physical Therapy and Occupational Therapy
Study officials:
affiliation: University of Sao Paulo
name: Isabel CN Sacco
role: STUDY_CHAIR
References:
citation: Sartor CD, Hasue RH, Cacciari LP, Butugan MK, Watari R, Passaro AC, Giacomozzi C, Sacco IC. Effects of strengthening, stretching and functional training on foot function in patients with diabetic neuropathy: results of a randomized controlled trial. BMC Musculoskelet Disord. 2014 Apr 27;15:137. doi: 10.1186/1471-2474-15-137.
citation: Sartor CD, Watari R, Passaro AC, Picon AP, Hasue RH, Sacco IC. Effects of a combined strengthening, stretching and functional training program versus usual-care on gait biomechanics and foot function for diabetic neuropathy: a randomized controlled trial. BMC Musculoskelet Disord. 2012 Mar 19;13:36. doi: 10.1186/1471-2474-13-36.