NCT04629040

Brief Summary

Investigators would let knee osteoarthritis patient dressing lateral wedge insole and evaluate the effect for foot pressure modification, quadriceps thickness detected with ultrasound and gait. Investigators would made the patient in control group dressing ordinary insole.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2020

Completed
17 days until next milestone

Study Start

First participant enrolled

November 13, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 16, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

February 1, 2021

Status Verified

January 1, 2021

Enrollment Period

8 months

First QC Date

October 27, 2020

Last Update Submit

January 28, 2021

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in foot pressure at week 12

    Investigators would use pressure insole to detect foot pressure of participants at baseline and 12 weeks after dressing insole

    Baseline and week 12

  • Change from baseline in quadriceps thickness at week 4, week 8 and week 12

    Investigators would use ultrasound to measure quadriceps thickness of participants at baseline, 4 weeks after dressing insole, 8 weeks after dressing insole and 12 weeks after dressing insole

    Baseline, week 4, week 8 and week 12

Study Arms (2)

Intervention

EXPERIMENTAL
Other: Lateral wedge insole

Control

PLACEBO COMPARATOR
Other: Ordinary insole

Interventions

Lateral wedge insoleOTHER

Lateral wedge insole for knee osteoarthritis patient

Intervention
Ordinary insoleOTHER

Ordinary insole

Control

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Knee osteoarthritis patients
  • Medial knee pain

You may not qualify if:

  • Unable to walk independently
  • Ambulation with device
  • Any neurologic disease
  • Rheumatoid arthritis, gouty arthritis
  • History of lower limbs fracture
  • History of operation for lower limbs
  • Any infectious disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asia University Hospital

Taichung, Taiwan

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Wei-Ching Hsu

CONTACT

+8860976517969hsuwc7117@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2020

First Posted

November 16, 2020

Study Start

November 13, 2020

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

February 1, 2021

Record last verified: 2021-01

Locations

TW(1)