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

NCT ID: NCT06318910

Last Updated: 2024-03-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2024-12-31

Brief 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.

Detailed Description

Participants will be allocated to the control (CFO without wedge) or experimental (CFO with W1 or W2) groups according to the seal-envelop randomization technique. Then, they will be assessed all outcomes for the baseline including pain intensity, foot function, lower-extremity muscle activity during gait and standing by the 2nd physical therapist. And the participants will receive the assigned treatment by the 1st physical therapist.

All participants will be asked to use the CFO in daily life during weight-bearing activities, and logbook, chat LINE, or phone call will be used to monitor the participants during the treatment program. They will be asked about activity they done in daily and a number of hour they used CFO per day in diary book. At least 4 hours per day of wearing CFO will be required to each participant. After 3 months of the CFO use, all outcomes will be re-assessed by the 2nd physical therapist. And such outcomes will be then statistically analyzed.

Conditions

Foot Orthoses; Fasciitis, Plantar

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CFO with W1

The therapists will propose the orthotic wedges after examining the foot angles following the foot assessment from the study of Root, the forefoot angle will be determined for both the forefoot and rearfoot wedges. Previous studies recommended the posting at 60% of the measured forefoot angle, up to a maximum of 8 degrees, for extrinsic forefoot varus wedge and the posting at 50% of the measured forefoot angle, up to a maximum of 6 degrees, for extrinsic rearfoot varus wedge. After the posting, all participants will be asked to test the provided foot orthoses within their footwear. If any disturbance has been found during testing, the adjustment will be performed.

Group Type: EXPERIMENTAL

orthotic wedge

Intervention Type: DEVICE

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.

CFO

Intervention Type: DEVICE

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.

CFO with W2

The therapists will propose the orthotic wedges after examining the foot angles following the foot assessment from the study of Monaghan et al., the forefoot will be posted at 50% of the measured forefoot angle, and the rearfoot will be posted at 20% of the measured rearfoot angle. After the posting, all participants will be asked to test the provided foot orthoses within their footwear. If any disturbance has been found during testing, the adjustment will be performed.

Group Type: EXPERIMENTAL

orthotic wedge

Intervention Type: DEVICE

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.

CFO

Intervention Type: DEVICE

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.

CFO without wedge

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.

Group Type: ACTIVE_COMPARATOR

CFO

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Reaching the specific criteria of PHP including

• A complaint of tenderness from the palpation of the medial calcaneal tubercle and the medial aspect of the proximal portion of the plantar fascia, or pain along the plantar fascia at medial longitudinal arch side
• The presence of heel pain immediately during the first few steps of walking in the morning or after a prolonged period of inactivity; and gradually decreased throughout the day with ordinary walking, and worsened with prolonged activity
• Having the symptom of heel pain for at least 6 weeks, indicates the chronic condition
• Having the maximum level of pain intensity during last week using the visual analog scale (VAS) at least 3 out of a full 10 scores

Exclusion Criteria

• Having positive sciatica test, indicating the L5-S1 nerve root irritation
• Having a history of lower extremity fracture
• Having a history of lower extremity surgery
• Having been diagnosed with gout, diabetic neuropathy, rheumatoid arthritis, systemic lupus erythematosus (SLE), cancer, infectious disease, and tumor

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

MU-SRF-RS-27 C/66

Identifier Type: -

Identifier Source: org_study_id