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CompletedNCT03468491Updated Aug 13, 2024

The Additional Effect of Hallux Valgus Correction on Runners With First Ray Instability and Patellofemoral Pain Syndrome

An interventional study of combined training and Proximal training in Patellofemoral Pain Syndrome and Hallux Valgus, sponsored by National Yang Ming Chiao Tung University. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-08-13.

Sponsored by National Yang Ming Chiao Tung University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 11 studies in Patellofemoral Pain Syndrome with a site in Taiwan — none open to participants now, none under way, none of them phase 3. Patellofemoral Pain Syndrome · Taiwan.

Started
2018
the only one that year
No phase
5 of 11
none open now
Registered
9th of 11
by date
Lead sponsor
1 of 11
National Yang Ming Chiao Tung University

Among the 11 studies in Patellofemoral Pain Syndrome with a site in Taiwan, this one is the only one that started in 2018, is one of 5 with no phase, and was the 9th registered.

Patellofemoral Pain Syndrome

297 studies on the registry are indexed under Patellofemoral Pain Syndrome; 74 are open to participants now.

Browse Patellofemoral Pain Syndrome studies →

Open to participants now

None of the 11 studies in Patellofemoral Pain Syndrome with a site in Taiwan is open now. The open studies under Patellofemoral Pain Syndrome, anywhere →

Who these studies take

Of the 45 Patellofemoral Pain Syndrome studies recruiting now, 3 (7%) set no upper age limit and 41 (91%) stop at 75 or younger; 7 take children under 18; 13 take healthy volunteers.

This study: 20 Years to 40 Years · all sexes · no healthy volunteers.

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Download CSVNarrow it in search →With an account: the 11 studies in Patellofemoral Pain Syndrome with a site in Taiwan as a file.
02

Study summary

The study purpose is to investigate the effectiveness of a program combining biomechanical taping with lower extremity neuromuscular exercises for runners with patellofemoral pain syndrome (PFPS) and hallux valgus

Read the detailed description

This will be a single-blind, experimental study with two treatment groups. A total of 30 college athletes with PFPS and hallux valgus and majoring in long distance running or soccer, or recreational runners in Taipei metropolitan area will be recruited. A set of clinical examination will be conducted to rule out abnormal knee structures, pathologies, or injuries apart from PFPS. The lower extremity alignment as well as hip and knee kinematics during a step down test will be tracked using Noraxon's myoMOTION system. Muscle activation of the muscles controlling the hip and knee movements during the step down test will be recorded using TELEmyo DTS of Noraxon. Hallux valgus angle will be measured with surface markers on photographs. Knee pain level will be rated in a visual analog scale. The investigators will analyze the data with Statistical Product and Service Solutions (SPSS) for Windows. Repeated-measure ANOVAs will be used to examine group-by-time interaction on all the outcome variables. All significance level will be set at 0.05.

03

Conditions studied

  • Patellofemoral Pain Syndrome
  • Hallux Valgus

Keywords

  • Patellofemoral pain syndrome
  • Runner
  • First ray instability
  • Lower extremity closed chain exercise
04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • High physical activity level (running at least 5 times/week and at least 2 hours/time)
  • Presenting anterior/retropatellar knee pain in the past 6 months
  • At least two of the following activities provocated symptom: Prolonged sitting, ascending and/or descending stairs, squatting, kneeling, running, limping
  • Not having any pathologies of knee joint (ligament tear, menisci injury, patellofemoral joint dislocation, tendinitis, bursitis...etc.)
  • With hallux valgus angle>15°
  • With 1st metatarsophalangeal joint instability
  • 20\~40 y/o

Exclusion criteria

Exclusion Criteria:

  • Lower extremities osteoarthritis
  • Systematic diseases such as rheumatoid arthritis, systemic lupus erythematosus, DM...etc.
  • Lower extremities fracture history
  • Surgical history of lower extremities
  • Neurological pathology that would interfere with gait
  • Hallux could not be corrected to neutral through passive correction
  • Low back pain and/or sacroiliac joint dysfunction in the past six months
  • Excessive femoral anteversion
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Combined training group

    Biomechanical taping will first being applied to the participants of the combined training group. They will be asked to perform following exercises in this session afterwards. As the treatment session goes on, a set of foot intrinsic muscle strengthening exercise and lower extremity neuromuscular exercise will be provided.

    Other: combined training

  • Active comparator
    Proximal training group

    For participants of the proximal training group, only a set of lower extremity neuromuscular exercise will be provided. This set of exercises is designed to be the same as for participants of combined training group.

    Other: Proximal training

Interventions

  • Othercombined training

    The whole intervention period will last for 6 weeks, 2 visits per week, 1 hour per visit in the Research Building Room 630 of National Yang Ming University. All programs will be under the supervision of a physiotherapist with 2-year experience individually. 1. Hallux valgus correction: 1.1 Joint alignment correction (Grade II joint mobilization, 10 times/set, 3 sets/visit) - 1st MTP joint distraction - Proximal talofibular joint anteroposterior glide - (Grade III joint mobilization if any restriction being found) 1.2 Biomechanical taping (using Dynamic taping, 1 time/ visit, keep the taping for 2 days minimum) 1.3 Foot intrinsic muscle strengthening (10 times/set for each exercise, 3 sets/visit): - Short foot exercise - Toespread out exercise - Heel-rise exercises 2. Lower extremity neuromuscular exercises: (10-15 times/set, 3 sets/visit) 2.1 Single lunge 2.2 Stepping down 2.3 Vertical squat 2.4 Vertical jumping

    Also known as: hallux valgus correction, lower extremity neuromuscular exercises

  • OtherProximal training

    1. Lower extremity neuromuscular exercises: (10-15 times/set, 3 sets/visit) 1.1 Single lunge 1.2 Stepping down 1.3 Vertical squat 1.4 Vertical jumping All exercises will first start on firm surface without additional resistance/weight. Later, settings will be gradually shifted into on firm surface with resisted band from random direction, on a cushion with/ without resisted band, on a BOSU balance trainer. Progression are made every 2 weeks ideally, while adjustments may be taken into concern due to individual differences.

    Also known as: lower extremity neuromuscular exercises

06

What researchers measure

Primary outcomes

  1. Displacement of femur in step-down test

    displacement recorded in cm/BMI

    Time frame: changes from baseline and after 6 weeks of intervention

  2. Displacement of tibia in step-down test

    displacement recorded in cm/BMI

    Time frame: changes from baseline and after 6 weeks of intervention

  3. Knee pain level

    The level of knee pain during daily activities will be quantified with visual analogue scale.

    Time frame: changes from baseline and after 6 weeks of intervention

  4. Changes of pain-free running distance

    The changes of pain-free running distance will be recorded in kilometers.

    Time frame: changes from baseline and after 6 weeks of intervention

  5. EMG amplitude of knee extensor

    amplitude recorded in %MVC

    Time frame: changes from baseline and after 6 weeks of intervention

  6. EMG amplitude of knee flexor

    amplitude recorded in %MVC

    Time frame: changes from baseline and after 6 weeks of intervention

  7. EMG amplitude of hip external rotator

    amplitude recorded in %MVC

    Time frame: changes from baseline and after 6 weeks of intervention

  8. changes of the muscle activation time between vastus medialis oblique and vastus lateralis

    changes of the muscle activation time recorded in second

    Time frame: changes from baseline and after 6 weeks of intervention

Secondary outcomes

  1. Tibiofemoral angle in relaxed standing

    recorded in degree

    Time frame: changes from baseline and after 6 weeks of intervention

  2. Hallux valgus angle in relaxed standing

    recorded in degree

    Time frame: changes from baseline and after 6 weeks of intervention

  3. Navicular drop

    navicular position changes between sitting and relaxed standing, recording in cm

    Time frame: changes from baseline and after 6 weeks of intervention

  4. Arch height index

    arch height in one leg standing, recording in the ratio of arch height and truncated foot length

    Time frame: changes from baseline and after 6 weeks of intervention

  5. Hip rotation angle in relaxed standing

    recorded in degree

    Time frame: changes from baseline and after 6 weeks of intervention

  6. Knee rotation angle in relaxed standing

    recorded in degree

    Time frame: changes from baseline and after 6 weeks of intervention

07

Study locations

1 site
  • National Yng Ming University
    Taipei City, 北投區 112, Taiwan
08

References and documents

Publications

  • Davis IS, Powers CM. Patellofemoral pain syndrome: proximal, distal, and local factors, an international retreat, April 30-May 2, 2009, Fells Point, Baltimore, MD. J Orthop Sports Phys Ther. 2010 Mar;40(3):A1-16. doi: 10.2519/jospt.2010.0302. No abstract available. PubMed 20195028 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2018 to primary completion in Sep 2018, 3 months.

Of 153 non-industry interventional studies with no phase under Patellofemoral Pain Syndrome, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 20. This study's 3 months is below that.

Counting every sponsor, half of 157 studies reached it within 11 months; a quarter within 4 and three quarters within 21.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 6, 2018
First posted
Mar 16, 2018
StartActual
Jun 1, 2018
Primary completionActual
Sep 30, 2018
CompletionActual
Jan 30, 2019
Last update
Aug 13, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03468491
Responsible party
Sponsor
First posted
Mar 16, 2018
Start date
Jun 1, 2018
Primary completion
Sep 30, 2018
Completion
Jan 30, 2019
Last update
Aug 13, 2024

Study contacts

be945a7ts@gmail.com Chen, PhD
study director · National Yang Ming Chiao Tung University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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