NCT06592898

Brief Summary

This study take 84 patients with Patellofemoral Pain Syndrome in Peking University Third Hospital during January to September in 2023 as subjects, aiming to explore the efficacy and intervention effects of three different static squat modes including straight leg raise, wall squat, direct squat and wall squat assisted by elastic bands for patients with PFPS, in order to providing theoretical basis and effective guidance for future home rehabilitation of patients with PFPS combined with mobile health.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

July 1, 2024

Enrollment Period

1 month

First QC Date

July 25, 2024

Last Update Submit

September 9, 2024

Conditions

Keywords

patellofemoral pain syndromestatic squatrehabilitation

Outcome Measures

Primary Outcomes (1)

  • Efficacy of three different static squat modes for home rehabilitation of patients with patellofemoral pain syndrome.

    Investigators assessed the efficacy of wall squat, direct squat and wall squat assisted by elastic bands by measure Kujala score, Lysholm score, VAS-W score, VAS-U score, thigh circumference score, results of peak knee torque in isokinetic muscle strength test and peak knee moment results for isokinetic muscle strength test by using USA Biodex isokinetic muscle strength tester at 3rd week and 6th week. Before statistics, the measurement data are tested for normality and homogeneity of variance. The data meet the conditions of normal distribution and homogeneity of variance, and the statistical results are expressed in the form of mean ± standard deviation (x ± s).Count data were analyzed by the chi-square test. P \<0.05 represents a statistically significant difference. Higher values for all scores proved better intervention treatment.

    6 weeks

Study Arms (4)

Control group: straight leg raise

ACTIVE COMPARATOR

The patient was supine position, one knee angle was 90°, the foot was flatted on the ground. The ankle was flexed to contract the quadriceps on the other side. Then straighten the knee joint and the hip was 30° and lift the thigh, the heel was about 20cm away from the ground, and put down the lower limb after 2 seconds. Ten times are in a group, each practice has 5 groups, rest between the groups is 1 minute. Practice 5 times a week, practice on both sides, take uniform respiration without holding breath.

Behavioral: straight leg raise

Experimental group A: wall squat

EXPERIMENTAL

The subjects' upper body was upright, the distance between feet was same as width of shoulder, and hands were placed on each side of the body or above the thighs. Tiptoes were towards the front, and perpendicular to the wall. The distance between the wall and heel was about a foot long, and the back was close to the wall, squatted slowly.

Behavioral: wall squat

Experimental group B: direct squat

EXPERIMENTAL

The subjects stood on the flat ground, the upper body was upright, the distance between feet was same as width of shoulder, and tiptoes were towards the front. The trunk was adjusted forward according to the Angle of static squat. The specific method is to adjust the trunk position to the line of the shoulder joint and knee joint perpendicular to the ground. Knee joint can bend at a large angle.The center of gravity was between the feet, put hands in front of body.The angle was set at 30° for the first two weeks, increased to 45° after two weeks, and set at 60° for the last two weeks.

Behavioral: direct squat

Experimental group C: wall squat assisted by elastic bands

EXPERIMENTAL

Based on wall squat, subjects put elastic band of 20 pounds between the thighs, open thighs and feet at a low speed, so that the elastic bands were slightly deformed and sence of resistance was obvious on the outside of the thighs.The angle was set at 30° for the first two weeks, increased to 45° after two weeks, and set at 60° for the last two weeks.

Behavioral: wall squat assisted by elastic bands

Interventions

The patient was supine position, one knee angle was 90°, the foot was flatted on the ground. The ankle was flexed to contract the quadriceps on the other side. Then straighten the knee joint and the hip was 30° and lift the thigh, the heel was about 20cm away from the ground, and put down the lower limb after 2 seconds. Ten times are in a group, each practice has 5 groups, rest between the groups is 1 minute. Practice 5 times a week, practice on both sides, take uniform respiration without holding breath.

Control group: straight leg raise
wall squatBEHAVIORAL

The subjects' upper body was upright, the distance between feet was same as width of shoulder, and hands were placed on each side of the body or above the thighs. Tiptoes were towards the front, and perpendicular to the wall. The distance between the wall and heel was about a foot long, and the back was close to the wall, squatted slowly.

Experimental group A: wall squat
direct squatBEHAVIORAL

The subjects stood on the flat ground, the upper body was upright, the distance between feet was same as width of shoulder, and tiptoes were towards the front. The trunk was adjusted forward according to the Angle of static squat. The specific method is to adjust the trunk position to the line of the shoulder joint and knee joint perpendicular to the ground. Knee joint can bend at a large angle. The center of gravity was between the feet, put hands in front of body.The angle was set at 30° for the first two weeks, increased to 45° after two weeks, and set at 60° for the last two weeks.

Experimental group B: direct squat

Based on wall squat, subjects put elastic band of 20 pounds between the thighs, open thighs and feet at a low speed, so that the elastic bands were slightly deformed and sence of resistance was obvious on the outside of the thighs.The angle was set at 30° for the first two weeks, increased to 45° after two weeks, and set at 60° for the last two weeks.

Experimental group C: wall squat assisted by elastic bands

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Meet the diagnostic criteria of PFPS.
  • Age between 20 and 45 years (to reduce the risk of suffer from patellofemoral joint bone joint)
  • Have no other treatments before the experiment.
  • Sign the informed consent form.

You may not qualify if:

  • Patients with a history of knee surgery.
  • With other lower limb injuries such as meniscus tear, bursitis, ligament injury, patellar tendon injury, joint degeneration, etc.
  • With a history of dislocation and subluxation of patellofemoral joint.
  • With cardiovascular vessels, lung, kidney and other important organs.
  • Not available to use mobile phone APP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

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

July 25, 2024

First Posted

September 19, 2024

Study Start

October 1, 2023

Primary Completion

November 1, 2023

Study Completion

December 1, 2023

Last Updated

September 19, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations