Effects of Foot Muscle Strengthening in Daily Activity in Diabetic Neuropathic Patients

NCT02790931 | Completed Results DMC

• 1 other identifier: LaBiMPH
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this trial is to investigate the effects of foot muscle strengthening in daily activity of patients with diabetic neuropathy.

Conditions

Diabetic Neuropathies

Keywords

diabetic foot; therapeutic exercises; foot; preventive care; rehabilitation; Diabetic Neuropathy

Outcome Measures

Primary Outcomes (3)

• Daily Physical Activity

  Calculate the number of steps per week

  12 weeks

• Self Selected Gait Speed

  self selected gait speed shod walking velocity in a walkway

  12 weeks

• Fast Gait Speed

  Fast gait speed shod walking velocity in a walkway

  12 weeks

Secondary Outcomes (11)

• Risk Classification of Plantar Ulceration

  12 weeks

• Foot Health and Functionality

  12 weeks

• Foot Strength

  12 weeks

• Foot and Ankle Kinematics During Gait

  baseline, 12 weeks

• Ankle and Knee Joint Moments and Power During Gait

  baseline, 12 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

Patients will receive a physical therapy intervention in groups twice/wk, and using a software twice/ wk for 3 months.

Other: Intervention Group

Control Group

NO INTERVENTION

Patients will not receive any exercise treatment, will not have acess to the software, but they will keep their recommended clinical treatment.

Interventions

Intervention Group OTHER

Patients will receive a physical therapy intervention in groups twice/wk, and using a software twice/ wk for 3 months, for foot and ankle strengthening, stretching and functional training. They must continue to exercise at home twice a week with the software supervision for one year.

Also known as: Foot and ankle kinesiotherapy

Intervention Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetes mellitus type 1 or 2
• Moderate or severe polyneuropathy confirmed with the fuzzy software
• Ability to walk independently in the laboratory
• Accessibility to electronic devices
• Loss of at least 4 degrees of ankle range of motion
• Loss of at least 1 degree of force in the clinical scale of the plantar interosseous or lumbrical muscles

You may not qualify if:

• Ulceration not healed for at least 6 months
• Hallux amputation or total amputation of the foot
• Receiving any physiotherapy intervention or offloading devices
• Neurological or orthopedic impairments
• Major vascular complications
• Severe retinopathy

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Universidade de São Paulo

São Paulo, 05360-160, Brazil

Location

Related Publications (2)

• Monteiro RL, Ferreira JSSP, Silva EQ, Cruvinel-Junior RH, Verissimo JL, Bus SA, Sacco ICN. Foot-ankle therapeutic exercise program can improve gait speed in people with diabetic neuropathy: a randomized controlled trial. Sci Rep. 2022 May 9;12(1):7561. doi: 10.1038/s41598-022-11745-0.

  PMID: 35534614 DERIVED

• Monteiro RL, Sartor CD, Ferreira JSSP, Dantas MGB, Bus SA, Sacco ICN. Protocol for evaluating the effects of a foot-ankle therapeutic exercise program on daily activity, foot-ankle functionality, and biomechanics in people with diabetic polyneuropathy: a randomized controlled trial. BMC Musculoskelet Disord. 2018 Nov 14;19(1):400. doi: 10.1186/s12891-018-2323-0.

  PMID: 30428863 DERIVED

Related Links

• Laboratory of Biomechanics of Human Movement and Posture website
• University of Sao Paulo website

MeSH Terms

Conditions

Diabetic Neuropathies; Diabetic Foot

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Isabel de Camargo Neves Sacco
• Organization: University of Sao Paulo

icnsacco@usp.br

+551130918426

Study Officials

• Isabel CN Sacco, PhD

  Associate Professor at São Paulo University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 25, 2016
• First Posted: June 6, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: December 27, 2024
• Results First Posted: April 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)