N/A
N=78
Effects of Foot Muscle Strengthening in Daily Activity in Diabetic Neuropathic Patients
Diabetic Neuropathies
Bottom Line
View on ClinicalTrials.gov: NCT02790931 ↗Enrolled (actual)
78
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Daily Physical Activity — 8744; 7373 number of steps per week
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intervention Group (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Sao Paulo General Hospital
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Daily Physical Activity |
8744; 7373 | — |
| PRIMARY Self Selected Gait Speed |
1.06; 1.00 | — |
| PRIMARY Fast Gait Speed |
1.68; 1.49 | — |
| SECONDARY Risk Classification of Plantar Ulceration |
— | — |
| SECONDARY Foot Health and Functionality |
— | — |
| SECONDARY Foot Strength |
— | — |
| SECONDARY Foot and Ankle Kinematics During Gait |
— | — |
| SECONDARY Ankle and Knee Joint Moments and Power During Gait |
— | — |
| SECONDARY Plantar Ulcers |
— | — |
| SECONDARY Tactile Sensitivity |
— | — |
| SECONDARY Vibration Sensitivity |
— | — |
| SECONDARY Neuropathy Symptoms |
— | — |
| SECONDARY Range of Motion |
— | — |
| SECONDARY EQ-5D Score |
— | — |
Summary
The main objective of this trial is to investigate the effects of foot muscle strengthening in daily activity of patients with diabetic neuropathy.
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
Data sourced from ClinicalTrials.gov (NCT02790931). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.