Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT06318910
NA

Customized Foot Orthoses on Muscle Activity During Standing and Gait in Plantar Heel Pain

Sponsor: Mahidol University

View on ClinicalTrials.gov

Summary

The present study will use a randomized controlled trial (RCT) to determine the effectiveness of customized foot orthosis (CFO) for the treatment of patients with PHP. Three treatment groups including the CFO without wedge, the CFO with wedge type 1 (W1), and the CFO with wedge type 2 (W2) will be randomly assigned to each participant by a computer-generated randomization. The opaque-sealed envelopes will be used to allocate the groups of participant.

Official title: Effects of Customized Foot Orthoses With Orthotic Wedges on Lower-extremity Muscle Activity During Standing and Gait in the Patients With Plantar Heel Pain: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

75

Start Date

2024-04-01

Completion Date

2024-12-31

Last Updated

2026-07-20

Healthy Volunteers

No

Interventions

DEVICE

orthotic wedge

The orthotic wedges with a full length of 3-mm soft foam layer will be provided to each participant under the molded orthoses; the amount of wedge angle will depend on the rearfoot and forefoot angles of the participants. The present study developed 3-degree, 6-degree, and 8-degree wedges for the rearfoot and forefoot. It was made from solid rubber with a cover of thin fabric. There are three sizes for these products which include small (S), medium (M), and large (L) sizes, according to the foot length of participants.

DEVICE

CFO

The 3-quarter-length CFO will be made from thermoplastic material (rigid foot orthoses) which consists of four layers i.e. two layers of 0.5-mm polyvinyl chloride (PVC), one layer of 1.5-mm thick fiber to increase strength of foot orthoses in the bottom layers as well as one layer of 1.2-mm genuine leather in the upper layer to increase comfort. It incorporates a heat-molding process to adjust individual foot shape in prone position. The materials will be set within approximately three minutes.

Locations (1)

Faculty of Physical Therapy, Mahidol University

Bangkok, Changwat Nakhon Pathom, Thailand