N/A
Completed N=78
Effects of Foot Muscle Strengthening in Daily Activity in Diabetic Neuropathic Patients
Diabetic Neuropathies
Source: ClinicalTrials.gov NCT02790931 ↗
Enrolled (actual)
78
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcomePrimary: Daily Physical Activity — 8744; 7373 number of steps per week
Summary
The main objective of this trial is to investigate the effects of foot muscle strengthening in daily activity of patients with diabetic neuropathy.
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 |
— | — |
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. Informational only — not medical advice.