NCT04923373

Brief Summary

The aim of this study was to assess the function, pain intensity and walking distance in patients prior to and after total knee arthroplasty, who received therapy either in a clinic under direct supervision of a physical therapist and patients who received telerehabilitation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2011

Completed
9.4 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 11, 2021

Completed
Last Updated

June 11, 2021

Status Verified

June 1, 2021

Enrollment Period

1.8 years

First QC Date

May 25, 2021

Last Update Submit

June 8, 2021

Conditions

Keywords

disabilitygeriatric

Outcome Measures

Primary Outcomes (4)

  • Change in 6 - Minute Walk Test

    Change in walking distance in 6 minutes ( in meters)

    Change from baseline- 1st measurement before total knee arthroplasty and final - 2nd measurement in 6 weeks after total knee arthroplasty and physiotherapy

  • Change in Knee Society Score

    Change in disability measured by Knee disability score (min 0 - max 200 points). Higher scores mean a better outcome.

    Change from baseline- 1st measurement before total knee arthroplasty and final - 2nd measurement in 6 weeks after total knee arthroplasty and physiotherapy

  • Change in range of knee motion [degrees]

    Change in knee flexion

    Change from baseline- 1st measurement before total knee arthroplasty and final - 2nd measurement in 6 weeks after total knee arthroplasty and physiotherapy

  • Change of knee pain intensity in Visual Analogue Scale

    Change of knee pain intensity (0-10), 0 - no pain, 10 - worst pain

    Change from baseline- 1st measurement before total knee arthroplasty and final - 2nd measurement in 6 weeks after total knee arthroplasty and physiotherapy

Study Arms (2)

telerehabilitation

EXPERIMENTAL

physiotherapeutic programme brochure exercises 7/week controlled by phone every week (5x in total)

Other: telerehabilitation

standard physiotherapy

ACTIVE COMPARATOR

Supervised physical therapy 3/ week, \+ physiotherapeutic programme brochure 4/week

Procedure: standard physiotherapy

Interventions

Procedure for both groups: I pre surgery evaluation 1. initial training in hospital 2. physiotherapeutic programme telerehabilitation versus standard 7 times a week Therapy duration: 6 weeks post-surgery II 6weeks post-surgery evaluation

telerehabilitation

standard physiotherapy

standard physiotherapy

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • total cemented knee arthroplasty with posterior stability (PS -cruciate sacrificing, posterior stabilized),
  • informed consent to participate in the study,
  • full medical record,
  • patients' regular control visits,
  • knee degenerative disorder stage II and III according to Altman classification,
  • ability to understand and independently perform the complete physiotherapeutic programme

You may not qualify if:

  • partial arthroplasty,
  • deformation aetiology other knee degenerative disorder,
  • cognitive disorders resulting in inability to fill out the study questionnaire, - degenerative disorders of multiple joints,
  • poor general health that prevented the patient from understanding or performing the full physiotherapeutic programme,
  • intraoperative and postoperative complications preventing the patient from understanding or performing the full physiotherapeutic programme,
  • lack of informed consent to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Szpital Specjalistyczny im. Świętej Rodziny

Rudna Mała, Podkarpackie Voivodeship, 36-060, Poland

Location

Related Publications (5)

  • Truszczynska-Baszak A, Dadura E, Drzal-Grabiec J, Tarnowski A. Static balance assessment in patients with severe osteoarthritis of the knee. Knee. 2020 Oct;27(5):1349-1356. doi: 10.1016/j.knee.2020.06.014. Epub 2020 Jul 27.

  • Benz T, Angst F, Oesch P, Hilfiker R, Lehmann S, Mueller Mebes C, Kramer E, Verra ML. Comparison of patients in three different rehabilitation settings after knee or hip arthroplasty: a natural observational, prospective study. BMC Musculoskelet Disord. 2015 Oct 24;16:317. doi: 10.1186/s12891-015-0780-2.

  • Russell TG, Buttrum P, Wootton R, Jull GA. Rehabilitation after total knee replacement via low-bandwidth telemedicine: the patient and therapist experience. J Telemed Telecare. 2004;10 Suppl 1:85-7. doi: 10.1258/1357633042614384.

  • Piqueras M, Marco E, Coll M, Escalada F, Ballester A, Cinca C, Belmonte R, Muniesa JM. Effectiveness of an interactive virtual telerehabilitation system in patients after total knee arthoplasty: a randomized controlled trial. J Rehabil Med. 2013 Apr;45(4):392-6. doi: 10.2340/16501977-1119.

  • Moffet H, Tousignant M, Nadeau S, Merette C, Boissy P, Corriveau H, Marquis F, Cabana F, Ranger P, Belzile EL, Dimentberg R. In-Home Telerehabilitation Compared with Face-to-Face Rehabilitation After Total Knee Arthroplasty: A Noninferiority Randomized Controlled Trial. J Bone Joint Surg Am. 2015 Jul 15;97(14):1129-41. doi: 10.2106/JBJS.N.01066.

MeSH Terms

Interventions

Telerehabilitation

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The patients (n=105) were randomly divided into two groups: telerehabilitation group (n=54) - 42 women and 12 men and control group (n=51) 40 women and 11 men - direct physiotherapist supervised group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 25, 2021

First Posted

June 11, 2021

Study Start

March 1, 2010

Primary Completion

December 15, 2011

Study Completion

December 15, 2011

Last Updated

June 11, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations