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

K

Klaus Widhalm

Status

Completed

Conditions

Hip Replacement

Treatments

Other: Supervised group exercise therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT06161194
CIP_SETT_RCT-THA

Details and patient eligibility

About

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.

Enrollment

38 patients

Sex

All

Ages

50 to 75 years old

Volunteers

No Healthy Volunteers

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").

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

38 participants in 2 patient groups

Intervention Group (IG)
Experimental group
Description:
IG will perform the home-exercise program supported by the digital real-time exercise feedback prototype for digitally guided training.
Treatment:
Other: Supervised group exercise therapy
Control Group (CG)
Active Comparator group
Description:
The CG will perform a usual care home-exercise by means of printed hand-outs describing each exercise.
Treatment:
Other: Supervised group exercise therapy

Trial contacts and locations

1

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Central trial contact

Klaus Widhalm

Data sourced from clinicaltrials.gov

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