Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06188091
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-01-03
First Post:
2023-12-05
Brief Title:
Joint Movement to Increase Range of Motion in Knee Joint After Primary Total Knee Arthroplasty
Sponsor:
Nordsjaellands Hospital
Organization:
Nordsjaellands Hospital
Study Overview
Official Title:
Impact of Active Joint Movement to Increase Range of Motion in Knee Joint After Primary or Revision Total Knee Arthroplasty
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROM
Brief Summary:
The goal of this clinical trail is to investigate if specific active exercises with a certain daily frequency improves the range of motion ROM in the knee joint after primary- or revision total knee arthroplasty TKA
The main questions it aims to answer are
Does it make a difference to the ROM of the knee joint to do specific active exercise 2 times a day compared to 8 times a day in an 18 days period of time
Analyze if range of motion in the knee joint after TKA has an impact on self-reported activity pain and physical activity
Participants will be instructed by a physiotherapist to do a specific exercise to improve the flexion of the knee-joint and and other to improve the extension of the knee-joint
One group will be instructed to do the exercises 2 times a day the other group to do the exercises 8 times a day in total of 18 days
The two groups will be compared to see if there is an effect in ROM and if the effect is significant between the groups if the intervention is done 2 times versus 8 times a day
The main questions it aims to answer are
Does it make a difference to the ROM of the knee joint to do specific active exercise 2 times a day compared to 8 times a day in an 18 days period of time
Analyze if range of motion in the knee joint after TKA has an impact on self-reported activity pain and physical activity
Participants will be instructed by a physiotherapist to do a specific exercise to improve the flexion of the knee-joint and and other to improve the extension of the knee-joint
One group will be instructed to do the exercises 2 times a day the other group to do the exercises 8 times a day in total of 18 days
The two groups will be compared to see if there is an effect in ROM and if the effect is significant between the groups if the intervention is done 2 times versus 8 times a day
Detailed Description:
There is a lack of knowledge about specific rehabilitation in relation to improving joint mobility of the knee joint especially in terms of frequency and the active roll of the patients The studies available describe predominantly passive joint mobilization after TKA machinetherapist Therefore there is a lack of knowledge about specific training methods regarding how patients can actively help increase joint mobility
The purpose of the study is to verify whether increased frequency of two specific active joint movement exercises for reduced flexion andor extension respectively at fixed daily intervals over a continuous 18-day period can further increase joint mobility after TKA
The hypothesis is that patients can increase joint mobility after TKA by repeating individual movement exercises with a high daily frequency
Based on previous clinical experience at the department and data from published articles a realistic assessment is that patients who receive intervention with a high frequency of joint movement exercises 8 times daily will be able to achieve an increased flexion of approx 12 degrees compared to low-frequency intervention 2 times daily where it is estimated that flexion can be increased by 4 degrees from baseline Thus there will be a change between the two intervention groups of 8 degrees
If this kind of focused movement training has an effect it will have a major impact on the composition of postoperative rehabilitation
Montebello is a department for specialized rehabilitation under North Zealand Hospital Capital Region of Denmark Patients are referred by doctors after determining the need for specialized rehabilitation due to a complicated course of the disease Thus it is patients who are accessed as needing a more intensive and specialized course than a usual general rehabilitation offers under municipal communities
Every year approx 1675 patients are received within various specialties of which between 250-300 patients are referred for knee care
Thus knee patients who are referred for admission to Montebello have all experienced complications in relation to their knee function This can be severe fractures complicated jointcartilage damage TKA with reduced mobility and subsequent brisement or revision TKA due to infection or anything else related to replacement of the osteosynthesis material
Intervention Both groups participate in exercise program based on group training in groups of 11 patients focused on improving knee function The general training consists of strength conditioning balance coordination walking and movement training Exercises are adjusted according to the individuals physical level and pain intensity The daily frequency of physical exercise is between 2-4 sessions per day approx 45 minutes per session
In addition instruction is given in appropriate training in relation to prosthesis and pain management education in strength and stability training instruction in the use of TENS Transcutaneous Electric Nerve Stimulation
Both groups will receive supervisioninstruction from the therapist about specific joint movement exercises to be performed on their own
Short-term and long- term risks
During the exercise patients may experience paintightening It is normal for irritation of the knee joint to occur after the exercises This irritation must have subsided before the next round of practice
Should it turn out that the patient cannot complete 2 or 8 repetitions without increased pain intensity they are excluded from the project Experience from the clinic shows that very few patients cannot complete the exercises many times a day Retrospectively it is estimated that approx 20 patients out of approx 2000 have not been able to complete the exercises due to increased pain It is very unlikely that the patients will have any long-term negative side effects from preforming the exercises
Collection of data Both intervention and control groups have their active joint mobility ROM of the knee joint on day 1 for exercise as well as day 18 for hospitalization
Measurement of ROM and secondary outcome is carried out by physiotherapists affiliated with other specialties in the department and thus do not have knowledge of which intervention group the individual patient belongs to Drawing for the intervention group takes place after data has been collected Therapists who perform measurements and tests also do not participate in the daily training of patients
Before the start of the examination the therapist who performs joint measurements will be trained in the procedure for measuring according to the chosen method to ensure optimal reliability of the measurement The same physiotherapist will be measuring the ROM at day 1 and day 18 on the specific patient
Therapists who measure ROM and perform the other tests are instructed not to ask the patient what intervention they have received during the re-testing process Likewise the patient is instructed not to talk about the intervention himself
The selected manual for measuring knee joint mobility by goniometer has been validated A goniometer with a 30 cm arm shall be used
It is assumed that a difference of more than 5represents a real clinical change in the same test
ROM is measured on the 1st day of training at 815 am and immediately afterwards other functional tests are performed On the 18th day of training measurements and tests are repeated at the same time
All measurements and tests performed on patients are already well known to therapists and are used daily on the ward
Statistics and analysis Baseline consists of measurements of ROM as well as the other of the numeric outcome variables collected on the 1st day of training
Measurements from the two intervention groups are compared against each other Paired t-tests will be performed for each of the intervention groups Unpaired t-test is used to test for change between the two intervention groups Results are considered significant when p005 Analysis of data will be carried out in the IBM SPSS Statistics
Sample size is calculated based on the expectation of 8 degree difference between low intensity compared to high intensity of movement exercises 4 vs 12 Standard deviation taken from 2018 department data data from patients with lack of flexion 105 or less Number in the two intervention groups 1-1 Power 80 and significance level 5
In this way it is calculated that in each intervention group there must be 30 patients and 20 6 persons to ensure size in case of dropout a total of 36 However as a solid data basis is desired the goal is to strengthen the study by including a total of 50 patients in each group
Ethics and data security Patients participating in this trial do not receive treatment that exposes them to invasive procedures new medication or otherwise exposes them to greater risk than the treatment normally included in the rehabilitation of TKA patients on the ward The intervention is exercises that are already included in many places in the rehabilitation of TKA patients and are generally used among physiotherapists as good clinical practice after TKA
The patients are informed that they can withdraw his or her consent at any time
Processing of personal data in the project
The study has been approved by the Danish Data Protection Agency The collected data will be stored according to rules of the data protection agency in the Capital Region All project data collected will be handled in accordance with the rules of the Capital Region in relation to current legislation No data are sent abroad
Funding The initiative to plan and execute the study is done by physiotherapist and development- and quality coordinator on the ward Support in terms of advice and statistical analyses are given from the research department at NOH There are no funding outside of the NOH and additional time used to execute the study is covered within the ward
No remuneration is paid to the project participants
Presentation of results The result should have interest to physiotherapist and orthopedic medical staff interested in rehabilitation after total knee arthroplasty both in Denmark and internationally
The study results will be presented in an article aim to be published in national and international peer reviewed journals and in public media Both positive negative and inconclusive results will be published The study will be registered at wwwclinicaltrails
Internally at the ward at NOH the results will be used to evaluate and reflect on the practice of current rehabilitation Depending of the results it might have influence on the rehabilitation offered to patients with primary-or revision total knee arthroplasty
The purpose of the study is to verify whether increased frequency of two specific active joint movement exercises for reduced flexion andor extension respectively at fixed daily intervals over a continuous 18-day period can further increase joint mobility after TKA
The hypothesis is that patients can increase joint mobility after TKA by repeating individual movement exercises with a high daily frequency
Based on previous clinical experience at the department and data from published articles a realistic assessment is that patients who receive intervention with a high frequency of joint movement exercises 8 times daily will be able to achieve an increased flexion of approx 12 degrees compared to low-frequency intervention 2 times daily where it is estimated that flexion can be increased by 4 degrees from baseline Thus there will be a change between the two intervention groups of 8 degrees
If this kind of focused movement training has an effect it will have a major impact on the composition of postoperative rehabilitation
Montebello is a department for specialized rehabilitation under North Zealand Hospital Capital Region of Denmark Patients are referred by doctors after determining the need for specialized rehabilitation due to a complicated course of the disease Thus it is patients who are accessed as needing a more intensive and specialized course than a usual general rehabilitation offers under municipal communities
Every year approx 1675 patients are received within various specialties of which between 250-300 patients are referred for knee care
Thus knee patients who are referred for admission to Montebello have all experienced complications in relation to their knee function This can be severe fractures complicated jointcartilage damage TKA with reduced mobility and subsequent brisement or revision TKA due to infection or anything else related to replacement of the osteosynthesis material
Intervention Both groups participate in exercise program based on group training in groups of 11 patients focused on improving knee function The general training consists of strength conditioning balance coordination walking and movement training Exercises are adjusted according to the individuals physical level and pain intensity The daily frequency of physical exercise is between 2-4 sessions per day approx 45 minutes per session
In addition instruction is given in appropriate training in relation to prosthesis and pain management education in strength and stability training instruction in the use of TENS Transcutaneous Electric Nerve Stimulation
Both groups will receive supervisioninstruction from the therapist about specific joint movement exercises to be performed on their own
Short-term and long- term risks
During the exercise patients may experience paintightening It is normal for irritation of the knee joint to occur after the exercises This irritation must have subsided before the next round of practice
Should it turn out that the patient cannot complete 2 or 8 repetitions without increased pain intensity they are excluded from the project Experience from the clinic shows that very few patients cannot complete the exercises many times a day Retrospectively it is estimated that approx 20 patients out of approx 2000 have not been able to complete the exercises due to increased pain It is very unlikely that the patients will have any long-term negative side effects from preforming the exercises
Collection of data Both intervention and control groups have their active joint mobility ROM of the knee joint on day 1 for exercise as well as day 18 for hospitalization
Measurement of ROM and secondary outcome is carried out by physiotherapists affiliated with other specialties in the department and thus do not have knowledge of which intervention group the individual patient belongs to Drawing for the intervention group takes place after data has been collected Therapists who perform measurements and tests also do not participate in the daily training of patients
Before the start of the examination the therapist who performs joint measurements will be trained in the procedure for measuring according to the chosen method to ensure optimal reliability of the measurement The same physiotherapist will be measuring the ROM at day 1 and day 18 on the specific patient
Therapists who measure ROM and perform the other tests are instructed not to ask the patient what intervention they have received during the re-testing process Likewise the patient is instructed not to talk about the intervention himself
The selected manual for measuring knee joint mobility by goniometer has been validated A goniometer with a 30 cm arm shall be used
It is assumed that a difference of more than 5represents a real clinical change in the same test
ROM is measured on the 1st day of training at 815 am and immediately afterwards other functional tests are performed On the 18th day of training measurements and tests are repeated at the same time
All measurements and tests performed on patients are already well known to therapists and are used daily on the ward
Statistics and analysis Baseline consists of measurements of ROM as well as the other of the numeric outcome variables collected on the 1st day of training
Measurements from the two intervention groups are compared against each other Paired t-tests will be performed for each of the intervention groups Unpaired t-test is used to test for change between the two intervention groups Results are considered significant when p005 Analysis of data will be carried out in the IBM SPSS Statistics
Sample size is calculated based on the expectation of 8 degree difference between low intensity compared to high intensity of movement exercises 4 vs 12 Standard deviation taken from 2018 department data data from patients with lack of flexion 105 or less Number in the two intervention groups 1-1 Power 80 and significance level 5
In this way it is calculated that in each intervention group there must be 30 patients and 20 6 persons to ensure size in case of dropout a total of 36 However as a solid data basis is desired the goal is to strengthen the study by including a total of 50 patients in each group
Ethics and data security Patients participating in this trial do not receive treatment that exposes them to invasive procedures new medication or otherwise exposes them to greater risk than the treatment normally included in the rehabilitation of TKA patients on the ward The intervention is exercises that are already included in many places in the rehabilitation of TKA patients and are generally used among physiotherapists as good clinical practice after TKA
The patients are informed that they can withdraw his or her consent at any time
Processing of personal data in the project
The study has been approved by the Danish Data Protection Agency The collected data will be stored according to rules of the data protection agency in the Capital Region All project data collected will be handled in accordance with the rules of the Capital Region in relation to current legislation No data are sent abroad
Funding The initiative to plan and execute the study is done by physiotherapist and development- and quality coordinator on the ward Support in terms of advice and statistical analyses are given from the research department at NOH There are no funding outside of the NOH and additional time used to execute the study is covered within the ward
No remuneration is paid to the project participants
Presentation of results The result should have interest to physiotherapist and orthopedic medical staff interested in rehabilitation after total knee arthroplasty both in Denmark and internationally
The study results will be presented in an article aim to be published in national and international peer reviewed journals and in public media Both positive negative and inconclusive results will be published The study will be registered at wwwclinicaltrails
Internally at the ward at NOH the results will be used to evaluate and reflect on the practice of current rehabilitation Depending of the results it might have influence on the rehabilitation offered to patients with primary-or revision total knee arthroplasty
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None