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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04923373
Other study ID # 2/11/2006
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2010
Est. completion date December 15, 2011

Study information

Verified date June 2021
Source University of Rzeszow
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The study population consisted of 105 patients who had knee arthroplasty due to knee arthrosis followed by 6- weeks physiotherapy, mean age 68.5 ± 7.3 years. The patients were randomly divided into two groups: I - telerehabilitation group (n=54), and II clinical control group (n=51), who received physiotherapy supervised by physiotherapist. All patients were given the following tests: VAS (0-10), 6-Minute Walk Test, and KSS - Knee Society Score.


Recruitment information / eligibility

Status Completed
Enrollment 105
Est. completion date December 15, 2011
Est. primary completion date December 15, 2011
Accepts healthy volunteers No
Gender All
Age group 50 Years to 80 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Poland Szpital Specjalistyczny im. Swietej Rodziny Rudna Mala Podkarpackie

Sponsors (1)

Lead Sponsor Collaborator
University of Rzeszow

Country where clinical trial is conducted

Poland, 

References & Publications (5)

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. 2 — View Citation

Moffet H, Tousignant M, Nadeau S, Mérette C, Boissy P, Corriveau H, Marquis F, Cabana F, Ranger P, Belzile ÉL, Dimentberg R. In-Home Telerehabilitation Compared with Face-to-Face Rehabilitation After Total Knee Arthroplasty: A Noninferiority Randomized Co — View Citation

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) — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
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