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

NCT ID: NCT01207284

Last Updated: 2013-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2013-06-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Physical Therapy

Foot and ankle passive and active stretching, muscle strengthening, proprioception training and gait training.

Group Type EXPERIMENTAL

Physical Therapy

Intervention Type OTHER

strengthening passive and active stretching balance training gait training

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Physical Therapy

strengthening passive and active stretching balance training gait training

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Isabel CN Sacco

Role: STUDY_CHAIR

University of Sao Paulo

Locations

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Department of Speech, Physical Therapy and Occupational Therapy

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 24767584 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22429765 (View on PubMed)

Other Identifiers

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LaBiMPH-001

Identifier Type: -

Identifier Source: org_study_id