Clinical trial NCT06161194: Efficacy of Real-time Feedback Exercise Therapy in Patients Following Total Hip Arthroplasty
Official title: Efficacy of Real-time Feedback Exercise Therapy in Patients Following Total Hip Arthroplasty: a Pilot Cluster-randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hip Replacement
Keywords: hip replacement
exercise therapy
real-time feedback
movement analysis
Lead sponsor: FH Campus Wien, University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: Orthopedic Hospital Vienna Speising
First posted: 2023-12-07
Enrollment: 38
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: cluster-randomized, two-arm parallel-group controlled trial
Primary purpose: TREATMENT

Brief summary: This pilot cluster-randomized, two-arm parallel-group controlled trial, aims at enhancing the understanding of the effects of real-time feedback on functional deficits as knee valgus thrust, pelvic drop, and lateral trunk lean after total hip arthroplasty. Biomechanical and patient-reported outcomes will be assessed after a total hip arthroplasty as well as at three and six months follow-ups. The primary research question is, whether digital real-time feedback supported home-exercising improves the control of the frontal knee range of motion, pelvic obliquity, and lateral trunk lean, superior to exercising supported by written instructions as comparator. The secondary aspect focuses on potential differences between groups concerning aspects of quality of life, function, and physical activity. Tertiary functional outcomes between groups will be compared for reasons of quantification movement quality.


Eligibility criteria: Inclusion Criteria:

* age from 50-75 years
* body mass index from 18.5 to 29.99 kg/m²
* able to walk without walking aids at baseline assessment
* scheduled for elective unilateral total hip arthroplasty surgery
* willing to comply with all study related procedures and provide informed consent

Exclusion Criteria:

* symptoms of delayed healing concerning the implant
* cardio-respiratory symptoms limiting exercise therapy (for example severe heart disease)
* symptoms of musculoskeletal or cardio-respiratory overload
* neuro-motor diseases (for example previous Stroke, Multiple Sclerosis, Morbus Parkinson Disease)
* other reasons which would lead to obvious limitations concerning their participation in the intervention (for example severe contralateral osteoarthritis (OA), lower extremity fractures within previous 12 months, other elective lower extremity surgery within 6 months, inadequacy in German concerning questionnaires and exercise instructions, mentally unable to participate)
* non-adherence (see definition under "therapeutic adherence").

Primary outcomes:
measure: Frontal knee angle range of motion Pelvic obliquity angle range of motion Frontal trunk angle range of motion
timeFrame: Baseline 4 weeks post-surgery; 3-months post-surgery; 6-months post-surgery
Secondary outcomes:
measure: Harris Hip Score (HHS) Hip Osteoarthritis Outcome Score (HOOS) Short-Form-Health Survey (SF12) International Physical Activity Questionnaire - short form (IPAQ) if applicable: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Baseline 4 weeks post-surgery; 3-months post-surgery; 6-months post-surgery
Other outcomes:
measure: 3D-movement-analysis parameters (kinematic, kinetic, spatio-temporal)
timeFrame: Baseline 4 weeks post-surgery; 3-months post-surgery; 6-months post-surgery
Locations:
city: Vienna
country: Austria
facility: Orthopaedic Hospital Vienna Speising
Study officials:
affiliation: FH Campus Wien, University of Applied Sciences
name: Klaus Widhalm
role: STUDY_DIRECTOR
References: