N/A N=50 Randomized Double-blind Treatment

Effect of Educational Booklet for Foot-related Exercises for Prevention and Treatment in People With Diabetic Neuropathy

Diabetic Neuropathies

Bottom Line

View on ClinicalTrials.gov: NCT04008745 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2024

Primary outcome: Primary: Change From Baseline Diabetic Neuropathy Symptoms at 8-weeks — 5.3; 6.2 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Educational and home-based physical therapy by foot-related exercises (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Sao Paulo General Hospital
Primary completion: May 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline Diabetic Neuropathy Symptoms at 8-weeks	5.3; 6.2	—
PRIMARY Change From Baseline of the Fuzzy Classification of the Diabetic Neuropathy Severity at 8-weeks	3.7; 3.3	—
PRIMARY Change From Baseline Diabetic Neuropathy Symptoms at 16-weeks (Follow-up)	5.6; 6.0	—
PRIMARY Change From Baseline of the Fuzzy Classification of the Diabetic Neuropathy Severity at 16-weeks (Follow-up)	3.9; 3.6	—
SECONDARY Change From Baseline of the Foot and Ankle Kinematics During Gait at 8-weeks	23.7; 22.7	—
SECONDARY Change From Baseline of the Foot and Ankle Kinetics During Gait at 8-weeks	1.3; 1.2	—
SECONDARY Change From Baseline Dynamic Plantar Pressure Distribution During Gait at 8-weeks	338.2; 402.4	—
SECONDARY Change From Baseline Tactile Sensitivity at 8-weeks	0; 0	—
SECONDARY Change From Baseline Vibration Sensitivity at 8-weeks	12; 11; 11; 9	—
SECONDARY Change From Baseline Foot Health and Functionality at 8-weeks	37.0; 36.3	—
SECONDARY Change From Baseline Foot Isometric Strength at 8-weeks	13.8; 11.6	—
SECONDARY Change From Baseline Functional Balance at 8-weeks	25.7; 25.5	—
SECONDARY Change From Baseline of the Foot and Ankle Kinematics During Gait at 16-weeks (Follow-up)	24.6; 24.6	—
SECONDARY Change From Baseline of the Foot and Ankle Kinetics During Gait at 16-weeks (Follow-up)	1.20; 1.25	—
SECONDARY Change From Baseline Dynamic Plantar Pressure Distribution During Gait at 16-weeks (Follow-up)	339.9; 378.4	—
SECONDARY Change From Baseline Tactile Sensitivity at 16-weeks (Follow-up)	0; 0	—
SECONDARY Change From Baseline Vibration Sensitivity at 16-weeks (Follow-up)	6; 2; 15; 15	—
SECONDARY Change From Baseline Foot Health and Functionality at 16-weeks (Follow-up)	40.3; 42.6	—
SECONDARY Change From Baseline Foot Isometric Strength at 16-weeks (Follow-up)	13.1; 12.0	—
SECONDARY Change From Baseline Functional Balance at 16-weeks (Follow-up)	26.0; 22.9	—

Summary

The main objective of this trial is to investigate the effect of an educational booklet foot-related exercise in diabetic neuropathy status, functional outcomes and gait biomechanics in people with diabetic neuropathy.

Eligibility Criteria

Inclusion Criteria

Diabetes mellitus type 1 or 2;
Moderate or severe neuropathy confirmed with the fuzzy software;
Ability to walk independently in the laboratory

Exclusion Criteria

Hallux amputation or total amputation of the foot;
History of surgical procedure in the knee, ankle or hip;
History of arthroplasty and / or lower limb orthosis or indication of lower limb arthroplasty throughout the intervention period;
Neurological and / or rheumatologic diseases diagnosed;
Inability to provide consistent information;
Perform physiotherapy intervention throughout the intervention period;
Receiving any physiotherapy intervention or offloading devices;
Major vascular complications;
Severe retinopathy;
Ulceration not healed for at least 6 months and / or active ulcer;
Score between 12-21 (Probable Depression) from the Hospital Anxiety and Depression Scale (HADS).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04008745). 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.