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BRIFE RESUME OF INTENDED WORK:
6.1 NEED OF THE STUDY:
Osteoarthritis is among the most prevalent musculoskeletal disorders and is the major cause of pain and disability in older individuals. The knee is the most common joint associated with dysfunction1.The primary surgical treatment of knee osteoarthritis patient is the replacement of native knee joint with a prosthesis (Total Knee Replacement). 90% of TKR are performed for the severe stage of osteoarthritis of knee.
TKR is one of the most common orthopedic procedures performed. In 2001, 171335 primary knee replacements were performed2 .By 2030 it is estimated that that there will be an 85% increase in TKR 3.
The objective of the TKR surgery is to provide the patient with a pain free, well aligned and stable knee joint whose function approaches that of a normal knee4.85% to95% of TKR patients report pain relief after surgery and 70 to 80% report functional improvement5 .These procedures are elective and expensive and because of prevalence of arthritis is expected to grow substantially as the population ages6,7.With improvements in surgical technique. Implant longevity and surgeon experience these procedures being performed on many patients (younger individuals, the very elderly, and those with multiple medical impairments or disabilities) who previously would not have been considered candidates for the surgery4
TKR patients without major preoperative complication (i.e. fever, infection, acute blood loss anemia) are discharged to home within a week8. The trend toward earlier hospital discharge after TKR has meant that patients are returning home during a more acute phase of recovery. These factors had direct implication for the rehabilitation of the patient with TKR.9.
In a consensus statement on TKR the national institute of health identified rehabilitation as the most understudied yet widely used practice concerning TKR10.The goals of rehabilitation after TKR are to obtain and maintain rapid recovery of knee ROM,to develop hip and knee strength, and to obtain functional independence11.After discharge to home , physiotherapy required, with a focus on progressing the distance and quality of gait without an assistive device ,stair climbing and strength and flexibility4.
After discharge from hospital some of the TKR patients would like to undergo out patient rehabilitation programme and on the other hand some of the TKR patient thought that they can do their exercise of their own so, they start home based exercise programme.
After one month from the date of discharge it is expected that both the groups of TKR patient would show some improvement in their functional activities. However, it is unknown whether the outcomes of TKR in these two groups will be similar or different when matched with age, gender and type of prosthesis.
The objective of this study is to compare the outcomes of TKR patients who will undergo for supervised physical therapy with unsupervised home based physical therapy.
6.2 REVIEW OF LITERATURE:
1) JANET K. FREBURGER et al (2000)12 had done a study to examine the relationship between the physical therapy utilization and outcomes of the care for patients following total hip arthroplasty.The results of the study preliminary evidence to support the use of physical therapy intervention in the acute care of the patient following total hip arthroplasty.
2) C.SOSIO et al (2005)13 a had done a study to evaluate the functional performance of the patients underwent to two different types of total knee replacement prosthesis and concluded that the functional performance of the patients is same ,regardless of the type of prosthesis implants.
3) VINCENT KR et al(2006)14 had done retrospective comparative study on 286 primary TKA patients and 138 revision TKA patients and concluded that primary and revision TKA patients make improvements in functional independence during in patient rehabilitation
4) WALSH MB et al(2006)15 had performed a retrospective study on 87 pairs of patients on the outcomes after rehabilitation for total replacement at IRF(inpatient rehabilitation facilities) and SNF(skilled nursing facilities) and given conclusion that when patients are matched for age ,gender, operative diagnosis, and admission ambulation FIM,those who received rehabilitation in the IRF had, on average,a shorter length of stay and superior functional outcomes than those treated in SNF.
5) BRANDER et al(2006)11 had done a study on rehabilitation after hip and knee joint replacement: Anexperience and evidence based approach to care.And he had concluded that post operative rehabilitation is to be done avoid post operative complication.
6) WELLER R et al (2008)17 had done a study to examine the physical function,gait and quality of the life of patients after total hip replacement randomly assigned to either atargeted home or centre based exercise programme. And concluded that targeted strengthening was effectie for both the home and centre based groups
7) TRIBE KJ et al(2005)18 had done a study to analyse the difference in patient health outcomes and out of pocket costs following hip and knee replacement for osteoarthritis between the patients who underwent home immediately after acute care hospital stay and those who were admitted to to inpatient rehabilitation care before going home .And he had concluded that majority of the total joint replacement patients can be discharged directly home and achieve excellent outcomes at 12 months post surgery.
8) RUTH SINGER et al( 2003)19 had done a studt on comparision of two home care protocols for total joint replacement and concluded that otal joint replacement patients who receiver the more effective home care protocols(9-12 visits) experienced comparable outcomes to those who received existing protocols (11-47 visits).
9) S.KIM et al (2008)20 had done a study to estimate the incidence of total knee replacement by age and sex and the trend of TKR utilization from 2002 to 2005 in South Korea.And found that the rate of TKR increased steadily from 20002 to 2005 in south korea.TKR rate in women wsa mich larger than that in men
10) SANDRA JO et al (2006)21 conducted a study on a randomized controlled trial of supervised versus unsupervised exercise programme for ambulatory stroke survivors and foud that supervised programme has a greater improvement trends than unsupervised programmes
11) L.M. March et al (2000)22 had done a study to assess changes in physical function and quality of life with the Western Ontario and McMaster Universities Index (WOMAC) and the instrument of the Medical Outcomes Study SF-36 Health Survey (MOS SF-36), respectively, in patients undergoing hip and knee joint replacement surgery and to compare the responsiveness of these outcomes measures 1 year after surgery. And concluded that WOMAC and MOS SF-36 detect significant and clinically meaningful changes in outcome after hip and knee replacement.
12) JOHN M STANG et al (2005)23 had done a study to compare the outcomes between home based exercise therapy programme and clinically based physical therapy programme .And concluded that after one month WOMAC scores gain by the subjects in the clinic treatment group as twice as compare to subjects who performed similar unsupervised exercise at home.
13) ROOS EM et al (1999 )24 had done s syudy on validity of WOMAC for use in Sweden and concluded that the swedis versiocn of WOMAC is valid,reliable and responsive instrument.
6.3 OBJECTIVES OF THE STUDY:
1) To compare the functional ability of TKR patients of who will undergo supervised and unsupervised exercise programme..
6.4 HYPOTHESIS:
(A) ALTERNATIVE HYPOTHESIS: There is significant difference in improvement
of functional ability amoung postoperative TKR subjects who undergoes supervised and
unsupervised exercise programme.
(B) NULL HYPOTHESIS: There is no significant difference in improvement of functional ability amoung postoperative TKR patients who undergoes supervised and unsupervised exercise programme.
7. MATERIALS AND METHODS:
7.1 STUDY DESIGN AND SETTING:
7.1.1 STUDY DESIGN:
Cohort study.
7.1.2 SOURCE OF DATA:
1) Sagar Apollo Hospital
2) Hosmat Hospital
7.2 METHODOLOGY
7.2.1 POPULATION:
Both male and female patients who underwent TKR and fulfill the selection criteria below mentioned.
7.2.2 SELECTION CRITERIA:
A. INCLUSION CRITERIA.
• Subjects who underwent for unilateral primary total knee replacement surgery.
• Age of 60 to 70 years.
• Both genders
• Subjects implanted with cemented prosthesis.
• Subjects who can understand and cooperate for the study.
B. EXCLUSION CRITERIA:
• Subjects suffering from arthritis of the other joint.
• Subjects suffering from any systemic chronic disease.
• Subjects should not have any complication of previous fracture and dislocation of lower limb joint.
• Subjects with any neurological problems
• Any mental disorder participants.
• Uncooperative subjects
7.2.3 SAMLING:
(A) Sampling Method:
Purposive sampling
(B) Sample size:
30 unilateral TKR patients. 15 patients in each group.
7.2.4 PROCEDURE:
According to inclusion and exclusion criteria 30 subjects will be selected and informed consent will be taken from the patients. At the time of discharge from the hospital functional abilities of the patient will be checked by WOMAC scale.
All the subjects are divided two groups(supervised and unsupervised) according to the sampling procedure after obtaining the ethical and informed consent form from the subjects.In these two groups, one will under go for supervised physical therapy and other group will undergo for unsupervised home based exercise programme.
After 3 weeks, from the date of discharge how much they will improve in their functional abilities will be checked by WOMAC scale.
Finally, the functional gains of one group that will undergo for supervised physical therapy is compared with the functional gains of the other group that will under go for unsupervised home based exercise programme.
7.2.4(a) DURATION AND FOLLOW UP OF THE STUDY
3 weeks for each participant.
7.2.4(b) MATERIAL USED:
Data collection sheet
WOMAC scale
7.3.1 OUTCOME MEASURE:
Womac scale
7.3.2 STATISTICAL ANALYSIS:
A Data analysis
• Wilcoxon Sign Test
• Mann Whitney U Test
7.4 (a) Does the study requires any interventions to be conducted on patients or other humans or animals?
This study requires intervention as used to assess WOMAC scale in TKR patients. All the above assessment procedures will not cause any harm to the individual subjects.
(B) Has the ethical consent for the study has been obtained from the institution?
Yes, it has been obtained from the Ethical clearance from is attached as appendix (II). An informed consent will be obtained prior to study in their native.