Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00492674
Status:
UNKNOWN
Last Update Posted:
2007-06-27
First Post:
2007-06-26
Brief Title:
The Effect of Perioperative Neuromuscular Training on the Outcome of Total Knee Arthroplasty
Sponsor:
Assaf-Harofeh Medical Center
Organization:
Assaf-Harofeh Medical Center
Study Overview
Official Title:
The Effect of Perioperative Neuromuscular Training on the Outcome of Total Knee Arthroplasty A Double Blind Randomized Prospective Study
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
NOT_YET_RECRUITING
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:
None
Brief Summary:
Introduction Total knee arthroplasty TKA is a consensus treatment for end-stage knee osteoarthritis The peri-operative rehabilitation is an important part of the outcome of such procedure Previous studies have shown that there is correlation between both pre-operative functional status and the intensiveness of the post-operative rehabilitation to the post operative function of the patient
An important part of the peri-operative rehabilitation in TKA is the neuromuscular control re-education
A novel biomechanical device comprising of four individually calibrated elements attached onto foot-worn platforms was recently developed This device is capable of bringing the patient to a functional bio-mechanical alignment during standing and walking while simultaneously strengthening dynamic stabilizers and training neuromuscular control by means of controlled biomechanical perturbations
Objectives The aim of this study is to evaluate the influence of pre and post operative training with the biomechanical device mentioned above on the functional outcome and quality of life of patients undergoing TKA
Design and Setting Randomized controlled and double blind prospective trial
Patients 120 patients who are candidates to TKA
Interventions Patients will randomly assigned into five groups active sham and control and will followed for fourteen months two moths pre-operative and twelve months post-operative All groups will undergo post-operative physical therapy PT according to the standard guidelines In addition the active groups will be treated with the device and its four biomechanical elements that had been individually calibrated for each patient The sham group will be treated with the same device however the biomechanical elements will have zero perturbation and will be positioned along the central longitudinal line of the shoe-platform The control group will be treated only according to the standard post-operative protocol
The five groups
1 Pre- operative BD training and post-operative PT and BD training
2 Pre- operative sham training and post-operative PT and BD training
3 Pre- operative sham training and post-operative PT and sham training
4 No pre-operative training according to the guidelines in Israel and post-operative PT and BD training
5 No pre-operative training according to the guidelines in Israel and post-operative PT and sham training
Primary Outcome Measures Spatio-temporal measures recorded by Gait-Rite and the Aggregated Locomotor Function ALF assessment
Secondary Outcome Measures Pain and function questionnaire measured by the Western Ontario and McMaster Osteoarthritis Index WOMAC and Quality of life will be evaluated by the SF-36 quality of life questionnaire
Measurements will be taken at day-1 two months before the TKA and at four more stations 1 Week prior to the TKA Three months post the TKA six months post the TKA and twelve months post the TKA
An important part of the peri-operative rehabilitation in TKA is the neuromuscular control re-education
A novel biomechanical device comprising of four individually calibrated elements attached onto foot-worn platforms was recently developed This device is capable of bringing the patient to a functional bio-mechanical alignment during standing and walking while simultaneously strengthening dynamic stabilizers and training neuromuscular control by means of controlled biomechanical perturbations
Objectives The aim of this study is to evaluate the influence of pre and post operative training with the biomechanical device mentioned above on the functional outcome and quality of life of patients undergoing TKA
Design and Setting Randomized controlled and double blind prospective trial
Patients 120 patients who are candidates to TKA
Interventions Patients will randomly assigned into five groups active sham and control and will followed for fourteen months two moths pre-operative and twelve months post-operative All groups will undergo post-operative physical therapy PT according to the standard guidelines In addition the active groups will be treated with the device and its four biomechanical elements that had been individually calibrated for each patient The sham group will be treated with the same device however the biomechanical elements will have zero perturbation and will be positioned along the central longitudinal line of the shoe-platform The control group will be treated only according to the standard post-operative protocol
The five groups
1 Pre- operative BD training and post-operative PT and BD training
2 Pre- operative sham training and post-operative PT and BD training
3 Pre- operative sham training and post-operative PT and sham training
4 No pre-operative training according to the guidelines in Israel and post-operative PT and BD training
5 No pre-operative training according to the guidelines in Israel and post-operative PT and sham training
Primary Outcome Measures Spatio-temporal measures recorded by Gait-Rite and the Aggregated Locomotor Function ALF assessment
Secondary Outcome Measures Pain and function questionnaire measured by the Western Ontario and McMaster Osteoarthritis Index WOMAC and Quality of life will be evaluated by the SF-36 quality of life questionnaire
Measurements will be taken at day-1 two months before the TKA and at four more stations 1 Week prior to the TKA Three months post the TKA six months post the TKA and twelve months post the TKA
Detailed Description:
Introduction Total knee arthroplasty TKA is a consensus treatment for end-stage knee osteoarthritis The peri-operative rehabilitation is an important part of the outcome of such procedure Previous studies have shown that there is correlation between both pre-operative functional status and the intensiveness of the post-operative rehabilitation to the post operative function of the patient
An important part of the peri-operative rehabilitation in TKA is the neuromuscular control re-education
A novel biomechanical device comprising of four individually calibrated elements attached onto foot-worn platforms was recently developed This device is capable of bringing the patient to a functional bio-mechanical alignment during standing and walking while simultaneously strengthening dynamic stabilizers and training neuromuscular control by means of controlled biomechanical perturbations
Objectives The aim of this study is to evaluate the influence of pre and post operative training with the biomechanical device mentioned above on the functional outcome and quality of life of patients undergoing TKA
Design and Setting Randomized controlled and double blind prospective trial
Patients 120 patients who are candidates to TKA
Interventions Patients will randomly assigned into five groups active sham and control and will followed for fourteen months two moths pre-operative and twelve months post-operative All groups will undergo post-operative physical therapy PT according to the standard guidelines In addition the active groups will be treated with the device and its four biomechanical elements that had been individually calibrated for each patient The sham group will be treated with the same device however the biomechanical elements will have zero perturbation and will be positioned along the central longitudinal line of the shoe-platform The control group will be treated only according to the standard post-operative protocol
The five groups
1 Pre- operative BD training and post-operative PT and BD training
2 Pre- operative sham training and post-operative PT and BD training
3 Pre- operative sham training and post-operative PT and sham training
4 No pre-operative training according to the guidelines in Israel and post-operative PT and BD training
5 No pre-operative training according to the guidelines in Israel and post-operative PT and sham training
Primary Outcome Measures Spatio-temporal measures recorded by Gait-Rite and the Aggregated Locomotor Function ALF assessment
Secondary Outcome Measures Pain and function questionnaire measured by the Western Ontario and McMaster Osteoarthritis Index WOMAC and Quality of life will be evaluated by the SF-36 quality of life questionnaire
Measurements will be taken at day-1 two months before the TKA and at four more stations 1 Week prior to the TKA Three months post the TKA six months post the TKA and twelve months post the TKA
An important part of the peri-operative rehabilitation in TKA is the neuromuscular control re-education
A novel biomechanical device comprising of four individually calibrated elements attached onto foot-worn platforms was recently developed This device is capable of bringing the patient to a functional bio-mechanical alignment during standing and walking while simultaneously strengthening dynamic stabilizers and training neuromuscular control by means of controlled biomechanical perturbations
Objectives The aim of this study is to evaluate the influence of pre and post operative training with the biomechanical device mentioned above on the functional outcome and quality of life of patients undergoing TKA
Design and Setting Randomized controlled and double blind prospective trial
Patients 120 patients who are candidates to TKA
Interventions Patients will randomly assigned into five groups active sham and control and will followed for fourteen months two moths pre-operative and twelve months post-operative All groups will undergo post-operative physical therapy PT according to the standard guidelines In addition the active groups will be treated with the device and its four biomechanical elements that had been individually calibrated for each patient The sham group will be treated with the same device however the biomechanical elements will have zero perturbation and will be positioned along the central longitudinal line of the shoe-platform The control group will be treated only according to the standard post-operative protocol
The five groups
1 Pre- operative BD training and post-operative PT and BD training
2 Pre- operative sham training and post-operative PT and BD training
3 Pre- operative sham training and post-operative PT and sham training
4 No pre-operative training according to the guidelines in Israel and post-operative PT and BD training
5 No pre-operative training according to the guidelines in Israel and post-operative PT and sham training
Primary Outcome Measures Spatio-temporal measures recorded by Gait-Rite and the Aggregated Locomotor Function ALF assessment
Secondary Outcome Measures Pain and function questionnaire measured by the Western Ontario and McMaster Osteoarthritis Index WOMAC and Quality of life will be evaluated by the SF-36 quality of life questionnaire
Measurements will be taken at day-1 two months before the TKA and at four more stations 1 Week prior to the TKA Three months post the TKA six months post the TKA and twelve months post the TKA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None