NCT06387524

Brief Summary

This study is a quasi experimental and the purpose of this study is to determine the effects of eccentric exercises on gait parameters in patellofemoral pain syndrome: a quasi - experimental study

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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

July 15, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 29, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2024

Completed
Last Updated

June 5, 2024

Status Verified

June 1, 2024

Enrollment Period

1.4 years

First QC Date

April 23, 2024

Last Update Submit

June 4, 2024

Conditions

Outcome Measures

Primary Outcomes (9)

  • Dynamic knee valgus angle

    2D analysis using a video camera will be used to analyze dynamic knee valgus, specifically the inward movement of the knees during task performance. Participants will be instructed to perform a single-leg squat task. They will also be directed to adequately flex the contralateral knee to prevent the foot from touching the floor. A digital video camera positioned at a 90-degree angle to the frontal plane will be placed on a tripod stand 2m in front of the participant's landing point at knee level for 2D video recording purposes. The recorded video will be processed into slow motion and exported to Kinovea software. Dynamic knee valgus angle (DKVA) will be calculated at the intersection point of two lines: the first line connecting markers placed on the anterior superior iliac spine (ASIS) and the middle of the tibio femoral joint, and the second line connecting the middle of the tibio femoral joint and the middle of the ankle mortise.

    6 weeks

  • Hip Range of Motion

    It will be measured with goniometer

    6 weeks

  • Knee Range of Motion

    It will be measured with goniometer

    6 weeks

  • Pain intensity

    Numeric pain rating scale will be used to access pain of the subject pre and post intervention.

    6 weeks

  • Gait Speed

    Gait speed is the distance that the patient has covered per unit time Calculated as: Gait speed = Distance (m) x time (s)

    6 weeks

  • Cadence

    Cadence is the number of steps patient takes per unit time. Calculated as: Cadence (steps/min) = steps counted x 60 / time (s)

    6 weeks

  • Stride length

    Stride length is the distance between two heel strikes of the same foot. Calculated as: SL (m) = speed (m/s) x cycle time (s)

    6 weeks

  • Step length

    Step length is the vertical distance between heels of two feet. Calculated as: Step length (m) = stride length/2

    6 weeks

  • Cycle length

    Cycle length is the time between the two heel strikes of one foot. Calculated as: Cycle time (s) = time (s) x 2/steps counted

    6 weeks

Study Arms (1)

Interventional group

EXPERIMENTAL

There will be only one group in the study. After application of Mc Connell taping, patients will perform eccentric exercises taught by the therapist for 6 weeks. Mentioned below are detailed protocols for the treatment of patellofemoral pain syndrome.

Procedure: McConnell TapingProcedure: ECCENTRIC EXERCISES:

Interventions

Begin with the patient in supine lying with the knee slightly bent. The knee should be completely relaxed and a foam roller or rolled up towel under the knee. Start the tape in line with the middle of the knee cap at the outer aspect of the knee. Using your thumb on top of the sports tape, gently push the patella towards the inner aspect of the knee whilst simultaneously using your fingers to pull the skin at the inner aspect of the knee towards the patella. Finish this taping technique at the inner aspect of the knee ensuring you have created some wrinkling of the skin at the inner aspect of the knee.

Interventional group

Performed for 6 weeks, in 3 sets of 10-12 repetitions each day. Detailed protocol is as under: Warm up phase (5 minutes) It will comprise of following components 5 minutes warm up exercise protocol: Marching in place while swinging your arm, rotating toe touching, walking jacks, leg swings, arm circles, shoulder shrugs Eccentric exercises: Each of the following exercise will be performed for 30 seconds, repetitions and hold time will increase with increasing weeks according to patient's stamina. Straight leg raise, side lying hip abduction, single leg bridging, supported double leg squatting, hip hikes,supported single leg squatting Following is the detailed description of Cool down phase: Hip stretch, cat cow stretch, oblique stretch, lower back stretch, calf stretch, cross body shoulder stretch

Interventional group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-35 years
  • Females
  • Having pain from at least 2 months
  • Pain score greater than 3 on NPRS
  • Retro patellar pain in at least two of the following activities:
  • Ascending, descending stairs
  • Hooping / jumping
  • Prolonged sitting with flexed knees
  • Kneeling and squatting
  • Pain on palpation of medial or lateral patellar facet.
  • Pain on palpation on anterior portion of medial or lateral femoral condyles.

You may not qualify if:

  • Diagnosed with Chondromalacia patellae
  • Instability of tibiofemoral joint
  • Subluxation of patellofemoral joint
  • Patellar instability
  • Previous surgery of lower limb
  • Negative findings on examination of knee ligaments, menisci and bursa.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Rawalpindi, Punjab Province, 46000, Pakistan

RECRUITING

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Central Study Contacts

Safa Rafaqat, MS-MSKPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Quasi experimental study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2024

First Posted

April 29, 2024

Study Start

July 15, 2023

Primary Completion

November 20, 2024

Study Completion

November 20, 2024

Last Updated

June 5, 2024

Record last verified: 2024-06

Locations