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

Diabetic Neuropathies Clinical Trial

Official title:

Effects of Foot Muscle Strengthening in Daily Activity, Biomechanics and Functionality of Foot and Ankle in Diabetic Polyneuropathy Patients: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02790931
• Other study ID #: LaBiMPH
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: December 2020

Study information

• Verified date: April 2024
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

A randomized controlled trial will be performed with 77 patients with diabetic neuropathy. The participants will be randomly assigned into either a control group (recommended foot care by international consensus with no exercises) or an intervention group which will receive 12-week physical therapy exercises, twice a week, under the supervision of a physiotherapist, and twice a week being remotely supervised by a software at home. Every exercise has its own progression depending on the subjects' execution, increasing in intensity and difficulty.

The subjects will be evaluated in 5 different moments (Baseline, 6 weeks, 12 weeks, 24 weeks and 1 year follow-up)

The hypothesis of this study is that the intervention group will increase daily activity levels, increase self-selected and rapid walking speed, reduce the incidence of plantar ulcers, increase foot health and functionality, improve symptoms, increase tactile and vibration sensitivity, increased passive range of motion, improved quality of life, increased isometric strength of the feet and production of beneficial biomechanical changes during walking compared to the control group after 12 weeks of intervention and follow-up year.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diabetic Neuropathies

Intervention

Other:
• Intervention Group
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.

Locations

Country	Name	City	State
Brazil	Universidade de São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily Physical Activity	Calculate the number of steps per week	12 weeks
Primary	Self Selected Gait Speed	self selected gait speed shod walking velocity in a walkway	12 weeks
Primary	Fast Gait Speed	Fast gait speed shod walking velocity in a walkway	12 weeks
Secondary	Risk Classification of Plantar Ulceration	Score of the classification of the plantar ulcer risk (IWG diabetic foot)	12 weeks
Secondary	Foot Health and Functionality	Score of the Foot Health Status questionnaire - BRAZIL	12 weeks
Secondary	Foot Strength	Hallux and lesser toes force measured by a pressure plate	12 weeks
Secondary	Foot and Ankle Kinematics During Gait	Foot joints and plantar arch motion, ankle range of motion, and maximum ankle extension and flexion during gait	baseline, 12 weeks
Secondary	Ankle and Knee Joint Moments and Power During Gait	Peak joint moment and eccentric and concentric power by inverse dynamic calculations	baseline, 12 weeks
Secondary	Plantar Ulcers	New cases of foot plantar ulcers	12 months
Secondary	Tactile Sensitivity	Evaluation of the tactile sensitivity of four plantar areas with 10g monofilament	12 weeks
Secondary	Vibration Sensitivity	Evaluation of the vibration sensitivity with tuning fork	12 weeks
Secondary	Neuropathy Symptoms	Score of the Michigan Neuropathy Screening Instrument questionnaire Michigan Neuropathy Screening Instrument (MNSI)	12 weeks
Secondary	Range of Motion	Manual goniometry of the range of motion of flexion and extension of the metatarsophalangeal joint of the hallux and ankle.	12 weeks
Secondary	EQ-5D Score	EQ-5D score of the quality of life of the patient	12 weeks

External Links

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