Dataset Information

Home-based rehabilitation programme compared with traditional physiotherapy for patients at risk of poor outcome after knee arthroplasty: the CORKA randomised controlled trial.

ABSTRACT:

Objectives

To evaluate whether a home-based rehabilitation programme for people assessed as being at risk of a poor outcome after knee arthroplasty offers superior outcomes to traditional outpatient physiotherapy.

Design

A prospective, single-blind, two-arm randomised controlled superiority trial.

Setting

14 National Health Service physiotherapy departments in the UK.

Participants

621 participants identified at high risk of a poor outcome after knee arthroplasty using a bespoke screening tool.

Interventions

A multicomponent home-based rehabilitation programme delivered by rehabilitation assistants with supervision from qualified therapists versus usual care outpatient physiotherapy.

Main outcome measures

The primary outcome was the Late-Life Function and Disability Instrument (LLFDI) at 12 months. Secondary outcomes were the Oxford Knee Score (a disease-specific measure of function), Knee injury and Osteoarthritis Outcome Score Quality of Life subscale, Physical Activity Scale for the Elderly, 5 dimension, 5 level version of Euroqol (EQ-5D-5L) and physical function assessed using the Figure of 8 Walk test, 30 s Chair Stand Test and Single Leg Stance.

Results

621 participants were randomised between March 2015 and January 2018. 309 were assigned to CORKA (Community Rehabilitation after Knee Arthroplasty) home-based rehabilitation, receiving a median five treatment sessions (IQR 4-7). 312 were assigned to usual care, receiving a median 4 sessions (IQR 2-6). The primary outcome, LLFDI function total score at 12 months, was collected for 279 participants (89%) in the home-based CORKA group and 287 participants (92%) in the usual care group. No clinically or statistically significant difference was found between the groups (intention-to-treat adjusted difference=0.49 points; 95% CI -0.89 to 1.88; p=0.48). There were no statistically significant differences between the groups on any of the patient-reported or physical secondary outcome measures at 6 or 12 months.There were 18 participants in the intervention group reporting a serious adverse event (5.8%), only one directly related to the intervention, all other adverse events recorded throughout the trial related to underlying chronic medical conditions.

Conclusions

The CORKA intervention was not superior to usual care. The trial detected no significant differences, clinical or statistical, between the two groups on either primary or secondary outcomes. CORKA offers an evaluation of an intervention utilising a different service delivery model for this patient group.

Trial registration number

ISRCTN13517704.

SUBMITTER: Barker KL

PROVIDER: S-EPMC8404435 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Formal rehabilitation programs are often assumed to be required after total knee arthroplasty to optimize patient recovery. Inpatient rehabilitation is a costly rehabilitation option after total knee arthroplasty and, in Australia, is utilized most frequently for privately insured patients. With the exception of comparisons with domiciliary services, no randomized trial has compared inpatient rehabilitation to any outpatient based program. The Hospital Inpatient versus HOme (HIHO) study primarily aims to determine whether 10 days of post-acute inpatient rehabilitation followed by a hybrid home program provides superior recovery of functional mobility on the 6-minute walk test (6MWT) compared to a hybrid home program alone following total knee arthroplasty. Secondarily, the trial aims to determine whether inpatient rehabilitation yields superior recovery in patient-reported function.This is a two-arm parallel randomized controlled trial (RCT), with a third, non-randomized, observational group. One hundred and forty eligible, consenting participants who have undergone a primary total knee arthroplasty at a high-volume joint replacement center will be randomly allocated when cleared for discharge from acute care to either 10 days of inpatient rehabilitation followed by usual care (a 6-week hybrid home program) or to usual care. Seventy participants in each group (140 in total) will provide 80% power at a significance level of 5% to detect an increase in walking capacity from 400 m to 460 m between the Home and Inpatient groups, respectively, in the 6MWT at 6 months post-surgery, assuming a SD of 120 m and a drop-out rate of <10%.The outcome assessor will assess participants at 10, 26 and 52 weeks post-operatively, and will remain blind to group allocation for the duration of the study, as will the statistician. Participant preference for rehabilitation mode stated prior to randomization will be accounted for in the analysis together with any baseline differences in potentially confounding characteristics as required.The HIHO Trial will be the first RCT to investigate the efficacy of inpatient rehabilitation compared to any outpatient alternative following total knee arthroplasty.U.S. National Institutes of Health Clinical Trials Registry (http://clinicaltrials.gov) ref: NCT01583153.

Project description:BACKGROUND:Physical rehabilitation is recommended after total knee arthroplasty (TKA). With the expected increase in TKA over the next few decades, it is important to find new ways of delivering cost-effective interventions. Technological interventions have been developed with this intent, but only preliminary evidence exists regarding their validity, with short follow-up times. OBJECTIVE:This study aimed to present the follow-up results of a feasibility study comparing two different home-based programs after TKA: conventional face-to-face sessions and a digital intervention performed through the use of an artificial intelligence-powered biofeedback system under remote clinical monitoring. METHODS:The digital intervention uses a motion tracker allowing 3D movement quantification, a mobile app and a Web portal. This study presents the results of the previous single-center, prospective, parallel-group, feasibility study including an 8-week active treatment stage and further assessments at 3 and 6 months post-TKA. Primary outcome was the Timed Up and Go score, and secondary outcomes were the Knee Osteoarthritis Outcome Scale (KOOS) score and knee range of motion. RESULTS:A total of 59 patients completed the study (30 in the digital intervention group and 29 in the conventional rehabilitation group) and follow-up assessments. During the active treatment stage, patients in the digital intervention group demonstrated high engagement and satisfaction levels, with an 82% retention rate. Both groups attained clinically relevant improvements from baseline to 6 months post-TKA. At the end of the 8-week program, clinical outcomes were superior in the digital intervention group. At the 3- and 6-month assessments, the outcomes remained superior for the Timed Up and Go score (P<.001) and all KOOS subscale scores (at 3 months, P<.001 overall; at 6 months, KOOS Symptoms: P=.006, Pain: P=.002, Activities of Daily Living: P=.001, Sports: P=.003, and Quality of Life: P=.001). There was progressive convergence between both groups in terms of the knee range of motion, which remained higher for standing flexion in the digital intervention group than the conventional group at 6 months (P=.01). For the primary outcome, at 6 months, the median difference between groups was 4.87 seconds (95% CI 1.85-7.47), in favor of the digital intervention group. CONCLUSIONS:The present study demonstrates that this novel digital intervention for independent home-based rehabilitation after TKA is feasible, engaging, and capable of maximizing clinical outcomes in comparison to conventional rehabilitation in the short and medium term; in addition, this intervention is far less demanding in terms of human resources. TRIAL REGISTRATION:ClinicalTrials.gov NCT03047252; https://clinicaltrials.gov/ct2/show/NCT03047252.

Project description:OBJECTIVE:To evaluate whether a progressive course of outpatient physiotherapy offers superior outcomes to a single physiotherapy review and home exercise based intervention when targeted at patients with a predicted poor outcome after total knee arthroplasty. DESIGN:Parallel group randomised controlled trial. SETTING:13 secondary and tertiary care centres in the UK providing postoperative physiotherapy. PARTICIPANTS:334 participants with knee osteoarthritis who were defined as at risk of a poor outcome after total knee arthroplasty, based on the Oxford knee score, at six weeks postoperatively. 163 were allocated to therapist led outpatient rehabilitation and 171 to a home exercise based protocol. INTERVENTIONS:All participants were reviewed by a physiotherapist and commenced 18 sessions of rehabilitation over six weeks, either as therapist led outpatient rehabilitation (progressive goal oriented functional rehabilitation protocol, modified weekly in one-one contact sessions) or as physiotherapy review followed by a home exercise based regimen (without progressive input from a physiotherapist). MAIN OUTCOME MEASURES:Primary outcome was Oxford knee score at 52 weeks, with a 4 point difference between groups considered to be clinically meaningful. Secondary outcomes included additional patient reported outcome measures of pain and function at 14, 26, and 52 weeks post-surgery. RESULTS:334 patients were randomised. Eight were lost to follow-up. Intervention compliance was more than 85%. The between group difference in Oxford knee score at 52 weeks was 1.91 (95% confidence interval -0.18 to 3.99) points, favouring the outpatient rehabilitation arm (P=0.07). When all time point data were analysed, the between group difference in Oxford knee score was a non-clinically meaningful 2.25 points (0.61 to 3.90, P=0.01). No between group differences were found for secondary outcomes of average pain (0.25 points, -0.78 to 0.28, P=0.36) or worst pain (0.22 points, -0.71 to 0.41, P=0.50) at 52 weeks or earlier time points, or of satisfaction with outcome (odds ratio 1.07, 95% confidence interval 0.71 to 1.62, P=0.75) or post-intervention function (4.64 seconds, 95% confidence interval -14.25 to 4.96, P=0.34). CONCLUSIONS:Outpatient therapist led rehabilitation was not superior to a single physiotherapist review and home exercise based regimen in patients at risk of poor outcomes after total knee arthroplasty. No clinically relevant differences were observed across primary or secondary outcome measures. TRIALS REGISTRATION:Current Controlled Trials ISRCTN23357609 and ClinicalTrials.gov NCT01849445.