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

Influence of Physical Therapy Intervention on the Foot and Ankle in Gait Biomechanics in Individuals With Diabetic Neuropathy: a Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Neuropathy With Loss of Sensation; Foot and Ankle Muscle Weakness; Foot and Ankle Range of Movement Restriction
• Intervention / Treatment: Other: Physical Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 1

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05360160
    • Department of Speech, Physical Therapy and Occupational Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Physical Therapy; Foot and ankle passive and active stretching, muscle strengthening, proprioception training and gait training.	Other: Physical Therapy; strengthening passive and active stretching balance training gait training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Peak pressure at lateral forefoot	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak pressure	In 5 foot areas: heel, midfoot, medial forefoot, hallux and toes.	12 weeks
Peak pressure	In foot areas: heel, midfoot, medial forefoot, lateral forefoot, hallux and toes.	24 weeks
Time-to-peak pressure	In 6 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux and toes.	12 weeks
Time-to-peak pressure	In 6 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux and toes.	24 weeks
Pressure-time integral	In 6 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux and toes.	12 weeks
Pressure-time integral	In 6 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux and toes.	24 weeks
Mean velocity of center of pressure displacement	In 7 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux, toes and total area.	12 weeks
Mean velocity of center or pressure displacement	In 7 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux, toes and total area.	24 weeks
Sagittal range of motion of ankle		12 weeks
Sagittal range of motion of ankle		24 weeks
Sagittal peak of extensor moment of ankle		12 weeks
Sagittal peak of extensor moment of ankle		24 weeks
Sagittal peak of flexor moment of ankle		12 weeks
Sagittal peak of flexor moment of ankle		24 weeks
Michigan Neuropathy Screening Instrument score for symptoms		12 weeks
Michigan Neuropathy Screening Instrument score for symptoms		24 weeks
Michigan Neuropathy Screening Instrument score for physical assessment		12 weeks
Michigan Neuropathy Screening Instrument score for physical assessment		24 weeks
Functional tests score		12 weeks
Functional tests score		24 weeks
Muscle function score		12 weeks
Muscle function score		24 weeks
Activities-Specific Balance Confidence Scale (ABC)		12 weeks
Activities-Specific Balance Confidence Scale (ABC)		24 weeks

Collaborators and Investigators

• 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
• Investigators: Study Chair: Isabel CN Sacco, University of Sao Paulo

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: September 20, 2010
• First Submitted That Met QC Criteria: September 21, 2010
• First Posted (Estimate): September 22, 2010

Study Record Updates

• Last Update Posted (Estimate): September 27, 2013
• Last Update Submitted That Met QC Criteria: September 26, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuromuscular Manifestations; Muscle Weakness; Diabetic Neuropathies
• Other Study ID Numbers: LaBiMPH-001