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

NCT01207284 | Completed Phase 1

• 1 other identifier: LaBiMPH-001
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Peak pressure at lateral forefoot

  12 weeks

Secondary Outcomes (24)

• Peak pressure

  12 weeks

• Peak pressure

  24 weeks

• Time-to-peak pressure

  12 weeks

• Time-to-peak pressure

  24 weeks

• Pressure-time integral

  12 weeks

Study Arms (2)

Physical Therapy

EXPERIMENTAL

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

Other: Physical Therapy

Control

NO INTERVENTION

Interventions

Physical Therapy OTHER

strengthening passive and active stretching balance training gait training

Physical Therapy

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Department of Speech, Physical Therapy and Occupational Therapy

São Paulo, São Paulo, 05360160, Brazil

Location

Related Publications (2)

• 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.

  PMID: 24767584 DERIVED

• 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.

  PMID: 22429765 DERIVED

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Isabel CN Sacco

  University of Sao Paulo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2010
• First Posted: September 22, 2010
• Study Start: August 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: June 1, 2013
• Last Updated: September 27, 2013

Record last verified: 2013-09

Locations

BR (1)