Efficacy of Real-time Feedback Exercise Therapy in Patients Following Total Hip Arthroplasty

Efficacy of Real-time Feedback Exercise Therapy in Patients Following Total Hip Arthroplasty: a Pilot Cluster-randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Hip Replacement
• Intervention / Treatment: Other: Supervised group exercise therapy

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1130
    • Orthopaedic Hospital Vienna Speising

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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").

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group (IG); IG will perform the home-exercise program supported by the digital real-time exercise feedback prototype for digitally guided training.	Other: Supervised group exercise therapy; Participants will participate in a 90 minutes supervised group exercise therapy program 2 times a week for 8 consecutive weeks.
Active Comparator: Control Group (CG); The CG will perform a usual care home-exercise by means of printed hand-outs describing each exercise.	Other: Supervised group exercise therapy; Participants will participate in a 90 minutes supervised group exercise therapy program 2 times a week for 8 consecutive weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frontal knee angle range of motion Pelvic obliquity angle range of motion Frontal trunk angle range of motion	Above listed angles derived from assessed Activities of Daily Living (ADL) tasks	Baseline 4 weeks post-surgery; 3-months post-surgery; 6-months post-surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
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)	Baseline 4 weeks post-surgery; 3-months post-surgery; 6-months post-surgery

Other Outcome Measures

Outcome Measure	Time Frame
3D-movement-analysis parameters (kinematic, kinetic, spatio-temporal)	Baseline 4 weeks post-surgery; 3-months post-surgery; 6-months post-surgery

Collaborators and Investigators

• Sponsor: Klaus Widhalm
• Collaborators: Orthopedic Hospital Vienna Speising
• Investigators: Study Director: Klaus Widhalm, FH Campus Wien, University of Applied Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2024
• Primary Completion (Actual): April 15, 2025
• Study Completion (Actual): May 5, 2025

Study Registration Dates

• First Submitted: November 30, 2023
• First Submitted That Met QC Criteria: November 30, 2023
• First Posted (Actual): December 7, 2023

Study Record Updates

• Last Update Posted (Actual): August 8, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: hip replacement; exercise therapy; real-time feedback; movement analysis
• Other Study ID Numbers: CIP_SETT_RCT-THA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Sharing Time Frame

The study protocol including the statistic analysis plan will be submitted for publication in Trials Journal at begin of 2024.

The final results will be submitted for publication to a relevant journal by the end of 2025.

• IPD Sharing Access Criteria: Open Access publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No