Telerehabilitation After Total Knee Arthroplasty

• Sponsor: University of Rzeszow (Other)
• Overall Status: Completed
• CT.gov ID: NCT04923373
• Collaborator: (none)
• Enrollment: 105
• Location: 1
• Arms: 2
• Actual Duration (Months): 21.5
• Patients Per Site Per Month: 4.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Telerehabilitation; Total Knee Arthoplasty; Physiotherapy	Other: telerehabilitation; Procedure: standard physiotherapy	N/A

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

• Study Type: Interventional
• Actual Enrollment: 105 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.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)
• Primary Purpose: Treatment
• Official Title: Early Function Recovery in Geriatric Patients With Total Knee Arthroplasty by Telerehabilitation
• Actual Study Start Date: Mar 1, 2010
• Actual Primary Completion Date: Dec 15, 2011
• Actual Study Completion Date: Dec 15, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: telerehabilitation physiotherapeutic programme brochure exercises 7/week controlled by phone every week (5x in total)	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
Active Comparator: standard physiotherapy Supervised physical therapy 3/ week, + physiotherapeutic programme brochure 4/week	Procedure: standard physiotherapy; standard physiotherapy

Outcome Measures

Primary Outcome Measures

1. Change in 6 - Minute Walk Test [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)

2. Change in Knee Society Score [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.

3. Change in range of knee motion [degrees] [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

4. Change of knee pain intensity in Visual Analogue Scale [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Szpital Specjalistyczny im. Świętej Rodziny	Rudna Mała	Podkarpackie	Poland	36-060

Sponsors and Collaborators

• University of Rzeszow

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Justyna Drzał-Grabiec, Professor, University of Rzeszow
• ClinicalTrials.gov Identifier: NCT04923373
• Other Study ID Numbers: 2/11/2006
• First Posted: Jun 11, 2021
• Last Update Posted: Jun 11, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Justyna Drzał-Grabiec, Professor, University of Rzeszow: disability; geriatric

Study Results

No Results Posted as of Jun 11, 2021