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Effect of a 3-month Intervention with Biomechanical and Sensorimotor Foot Orthoses on Pain and Gait Kinematics in Patellofemoral Knee Patients – A Randomized Controlled Clinical Study

Effect of a 3-month Intervention with Biomechanical and Sensorimotor Foot Orthoses on Pain and Gait Kinematics in Patellofemoral Knee Patients – A Randomized Controlled Clinical Study - SMFO-study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
DRKS
Registry ID
DRKS00035082
Enrollment
27
Registered
2024-09-17
Start date
2024-03-14
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M22.2

Interventions

Group 1: Intervention group wearing SMFO (sensorimotor foot orthoses) over 3-month intervention period Group 2: Control group wearing BMFO (biomechanical foot orthoses) over 3-month intervention perio

Sponsors

Rheinland-Pfälzische Technische Universität
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 60 Years

Inclusion criteria

Inclusion criteria: - Knee pain (anterior, retropatellar) during at least two weight-bearing activities (walking up stairs, squatting, standing up): Pain during these activities on most days in the last month that is =30 mm on a 100 mm visual analog scale (VAS) - Insole indication due to foot misalignment/strain - Indications to be included: Chondropathia patellae up to grade 3 with pathological alignment and femoral antetorsion; femoropatellar pain syndrome; runner's knee, jumper's knee - Altered Q-angle of the lower extremity (“malalignment”) / recognizable rotational abnormality of the foot and tibia/femur during gait

Exclusion criteria

Exclusion criteria: - Post knee joint arthroplasty or osteotomy - Previous (surgical) treatment (< 12 months) in the area of the ankle, knee or hip joint - X-ray evidence of fixed bone deformity or joint erosion - Moderate or severe concomitant tibiofemoral OA (Kellgren and Lawrence grade =3 on anteroposterior X-ray) - Underlying neurological pathology - Known underlying rheumatic disease with drug treatment - Acute muscle/ligament injury (< 4 weeks) with associated restriction of the musculoskeletal system

Design outcomes

Primary

MeasureTime frame
Subjective pain reduction in the affected knee

Secondary

MeasureTime frame
Kinematic changes of the ankle and knee joint angles as part of a gait analysis and a front-step-down test

Countries

Germany

Contacts

Public ContactSteven Simon

Rheinland-Pfälzische Technische Universität

steven.simon@rptu.de+49 (0) 631 205 5739

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026