Clinical trial NCT02790931: Effects of Foot Muscle Strengthening in Daily Activity in Diabetic Neuropathic Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Neuropathies
Keywords: diabetic foot
therapeutic exercises
foot
preventive care
rehabilitation
Diabetic Neuropathy
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2016-06-06
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Daily Physical Activity
timeFrame: 12 weeks
measure: Self Selected Gait Speed
timeFrame: 12 weeks
measure: Fast Gait Speed
timeFrame: 12 weeks
Secondary outcomes:
measure: Risk Classification of Plantar Ulceration
timeFrame: 12 weeks
measure: Foot Health and Functionality
timeFrame: 12 weeks
measure: Foot Strength
timeFrame: 12 weeks
measure: Foot and Ankle Kinematics During Gait
timeFrame: baseline, 12 weeks
measure: Ankle and Knee Joint Moments and Power During Gait
timeFrame: baseline, 12 weeks
measure: Plantar Ulcers
timeFrame: 12 months
measure: Tactile Sensitivity
timeFrame: 12 weeks
measure: Vibration Sensitivity
timeFrame: 12 weeks
measure: Neuropathy Symptoms
timeFrame: 12 weeks
measure: Range of Motion
timeFrame: 12 weeks
measure: EQ-5D Score
timeFrame: 12 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Universidade de São Paulo
Study officials:
affiliation: Associate Professor at São Paulo University
name: Isabel CN Sacco, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.