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

Primary Purpose

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

Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Physical Therapy
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Neuropathy With Loss of Sensation

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Speech, Physical Therapy and Occupational Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Physical Therapy

Control

Arm Description

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

Outcomes

Primary Outcome Measures

Peak pressure at lateral forefoot

Secondary Outcome Measures

Peak pressure
In 5 foot areas: heel, midfoot, medial forefoot, hallux and toes.
Peak pressure
In foot areas: heel, midfoot, medial forefoot, lateral forefoot, hallux and toes.
Time-to-peak pressure
In 6 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux and toes.
Time-to-peak pressure
In 6 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux and toes.
Pressure-time integral
In 6 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux and toes.
Pressure-time integral
In 6 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux and toes.
Mean velocity of center of pressure displacement
In 7 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux, toes and total area.
Mean velocity of center or pressure displacement
In 7 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux, toes and total area.
Sagittal range of motion of ankle
Sagittal range of motion of ankle
Sagittal peak of extensor moment of ankle
Sagittal peak of extensor moment of ankle
Sagittal peak of flexor moment of ankle
Sagittal peak of flexor moment of ankle
Michigan Neuropathy Screening Instrument score for symptoms
Michigan Neuropathy Screening Instrument score for symptoms
Michigan Neuropathy Screening Instrument score for physical assessment
Michigan Neuropathy Screening Instrument score for physical assessment
Functional tests score
Functional tests score
Muscle function score
Muscle function score
Activities-Specific Balance Confidence Scale (ABC)
Activities-Specific Balance Confidence Scale (ABC)

Full Information

First Posted
September 20, 2010
Last Updated
September 26, 2013
Sponsor
University of Sao Paulo General Hospital
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT01207284
Brief Title
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

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathy With Loss of Sensation, Foot and Ankle Muscle Weakness, Foot and Ankle Range of Movement Restriction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical Therapy
Arm Type
Experimental
Arm Description
Foot and ankle passive and active stretching, muscle strengthening, proprioception training and gait training.
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Physical Therapy
Intervention Description
strengthening passive and active stretching balance training gait training
Primary Outcome Measure Information:
Title
Peak pressure at lateral forefoot
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Peak pressure
Description
In 5 foot areas: heel, midfoot, medial forefoot, hallux and toes.
Time Frame
12 weeks
Title
Peak pressure
Description
In foot areas: heel, midfoot, medial forefoot, lateral forefoot, hallux and toes.
Time Frame
24 weeks
Title
Time-to-peak pressure
Description
In 6 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux and toes.
Time Frame
12 weeks
Title
Time-to-peak pressure
Description
In 6 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux and toes.
Time Frame
24 weeks
Title
Pressure-time integral
Description
In 6 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux and toes.
Time Frame
12 weeks
Title
Pressure-time integral
Description
In 6 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux and toes.
Time Frame
24 weeks
Title
Mean velocity of center of pressure displacement
Description
In 7 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux, toes and total area.
Time Frame
12 weeks
Title
Mean velocity of center or pressure displacement
Description
In 7 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux, toes and total area.
Time Frame
24 weeks
Title
Sagittal range of motion of ankle
Time Frame
12 weeks
Title
Sagittal range of motion of ankle
Time Frame
24 weeks
Title
Sagittal peak of extensor moment of ankle
Time Frame
12 weeks
Title
Sagittal peak of extensor moment of ankle
Time Frame
24 weeks
Title
Sagittal peak of flexor moment of ankle
Time Frame
12 weeks
Title
Sagittal peak of flexor moment of ankle
Time Frame
24 weeks
Title
Michigan Neuropathy Screening Instrument score for symptoms
Time Frame
12 weeks
Title
Michigan Neuropathy Screening Instrument score for symptoms
Time Frame
24 weeks
Title
Michigan Neuropathy Screening Instrument score for physical assessment
Time Frame
12 weeks
Title
Michigan Neuropathy Screening Instrument score for physical assessment
Time Frame
24 weeks
Title
Functional tests score
Time Frame
12 weeks
Title
Functional tests score
Time Frame
24 weeks
Title
Muscle function score
Time Frame
12 weeks
Title
Muscle function score
Time Frame
24 weeks
Title
Activities-Specific Balance Confidence Scale (ABC)
Time Frame
12 weeks
Title
Activities-Specific Balance Confidence Scale (ABC)
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabel CN Sacco
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Speech, Physical Therapy and Occupational Therapy
City
Sao Paulo
ZIP/Postal Code
05360160
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
24767584
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.
Results Reference
derived
PubMed Identifier
22429765
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.
Results Reference
derived

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

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