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Effects of Exercise Using Sound Stimulation and Therapeutic Footwear for the Prevention of Foot Wounds in Patients with Diabetes

The Effect of a Hybrid Therapy Combining Acoustic Stimulation and Therapeutic Footwear in Patients With Type 2 Diabetes: A Randomized Controlled Trial - SHOE-SOUND Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000060096
Enrollment
66
Registered
2025-12-16
Start date
2025-02-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Interventions

In the control group, physical therapists provide standard exercise instruction, including guidance on exercise intensity and frequency, walking instruction, resistance exercise instruction, education
s self-selected comfortable walking speed to assess walking speed, gait sway, and maximum plantar pressure, and we provide feedback based on the results. In addition, we monitor the incidence of foot
s self-selected comfortable walki

Sponsors

Gifu University of Health Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The eligibility criterion for participants is an age of 75 years or younger.

Exclusion criteria

Exclusion criteria: Exclusion criteria include participants who require orthopedic treatment; those with a history of central nervous system disorders; those with severe diabetic retinopathy or nephropathy; those with severe heart disease; those experiencing foot pain; and those deemed unsuitable for exercise therapy by a physician.

Design outcomes

Primary

MeasureTime frame
Maximum plantar pressure during self-paced comfortable walking at 12 months after initiation of the intervention.

Secondary

MeasureTime frame
Walking speed, step length, quadriceps strength, grip strength, and gait sway at 12 months after initiation of the intervention.

Countries

Japan

Contacts

Public ContactKeisuke Suzuki

Gifu University of Health Sciences Department of Physical Therapy, Faculty of Rehabilitation

k-suzuki@gifuhoken.ac.jp058-274-5001

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026