TelerehabilitationNCT04923373
Telerehabilitation After Total Knee Arthroplasty
A study testing telerehabilitation and standard physiotherapy in people with Telerehabilitation and Total Knee Arthoplasty, run by University of Rzeszow at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Telerehabilitation, Total Knee Arthoplasty, Physiotherapy
- What is being tested?
- telerehabilitation and standard physiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 sitePoland
- Study dates
- 1 Mar 2010to 15 Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Szpital Specjalistyczny im. Świętej Rodziny
Rudna Mała, Podkarpackie Voivodeship, 36-060
About this study
Official title: Early Function Recovery in Geriatric Patients With Total Knee Arthroplasty by Telerehabilitation
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.
Read the detailed 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.
- Conditions
- Telerehabilitation, Total Knee Arthoplasty, Physiotherapy
- Being tested
- telerehabilitation, standard physiotherapy
- Keywords
- disability, geriatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telerehabilitationOther
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
standard physiotherapyProcedure or surgery
standard physiotherapy
| Study group | Role | What they receive |
|---|---|---|
| telerehabilitation | Experimental | physiotherapeutic programme brochure exercises 7/week controlled by phone every week (5x in total) Receives: Other: telerehabilitation |
| standard physiotherapy | Active comparator | Supervised physical therapy 3/ week,
+ physiotherapeutic programme brochure 4/week Receives: Procedure: standard physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6 - Minute Walk Test
Change in walking distance in 6 minutes ( in meters)
Measured: 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.
Measured: 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
Measured: 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
Measured: Change from baseline- 1st measurement before total knee arthroplasty and final - 2nd measurement in 6 weeks after total knee arthroplasty and physiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start1 Mar 2010
- Primary completion15 Dec 2011
- Study completion15 Dec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for TelerehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rzeszow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justyna Drzał-Grabiec, University of Rzeszow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923373
- Sponsor's protocol ID
- 2/11/2006
- Status last verified
- Jun 2021
- First submitted
- 25 May 2021
- Last updated
- 11 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33010747Benz 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.
PubMed 26497597Russell 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.
PubMed 15603622Piqueras 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.
PubMed 23474735Moffet 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.
PubMed 26178888
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Function Recovery in Geriatric Patients With Total Knee Arthroplasty by Telerehabilitation
- ClinicalTrials.gov ID
- NCT04923373
- Acronym / sponsor ID
- 2/11/2006
- Conditions
- Telerehabilitation, Total Knee Arthoplasty, Physiotherapy
- Keywords
- disability, geriatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of RzeszowUniversity, hospital or other
- Study start
- 1 Mar 2010 (actual)
- Primary completion
- 15 Dec 2011 (actual)
- Study completion
- 15 Dec 2011 (actual)
- First posted
- 11 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| telerehabilitation | Experimental | Other: telerehabilitationphysiotherapeutic programme brochure exercises 7/week controlled by phone every week (5x in total) |
| standard physiotherapy | Active comparator | Procedure: standard physiotherapySupervised physical therapy 3/ week, + physiotherapeutic programme brochure 4/week |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| telerehabilitationProcedure 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 | Other | telerehabilitation |
| standard physiotherapystandard physiotherapy | Procedure or surgery | standard physiotherapy |
Primary outcome
Change in 6 - Minute Walk Test
Time frame: Change from baseline- 1st measurement before total knee arthroplasty and final - 2nd measurement in 6 weeks after total knee arthroplasty and physiotherapy
Change in walking distance in 6 minutes ( in meters)
Change in Knee Society Score
Time frame: Change from baseline- 1st measurement before total knee arthroplasty and final - 2nd measurement in 6 weeks after total knee arthroplasty and physiotherapy
Change in disability measured by Knee disability score (min 0 - max 200 points). Higher scores mean a better outcome.
Change in range of knee motion [degrees]
Time frame: 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 flexion
Change of knee pain intensity in Visual Analogue Scale
Time frame: 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 (0-10), 0 - no pain, 10 - worst pain
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Results publication: PubMed 33010747Truszczynska-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.
- Results publication: PubMed 26497597Benz 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.
- Results publication: PubMed 15603622Russell 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.
- Results publication: PubMed 23474735Piqueras 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.
- Results publication: PubMed 26178888Moffet 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing telerehabilitation and standard physiotherapy in people with Telerehabilitation and Total Knee Arthoplasty, run by University of Rzeszow at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 6 - Minute Walk Test (time frame: Change from baseline- 1st measurement before total knee arthroplasty and final - 2nd measurement in 6 weeks after total knee arthroplasty and physiotherapy). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04923373, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021.