Dataset Information

Economic evaluation of robot-assisted training versus an enhanced upper limb therapy programme or usual care for patients with moderate or severe upper limb functional limitation due to stroke: results from the RATULS randomised controlled trial.

ABSTRACT:

Objective

To determine whether robot-assisted training is cost-effective compared with an enhanced upper limb therapy (EULT) programme or usual care.

Design

Economic evaluation within a randomised controlled trial.

Setting

Four National Health Service (NHS) centres in the UK: Queen's Hospital, Barking, Havering and Redbridge University Hospitals NHS Trust; Northwick Park Hospital, London Northwest Healthcare NHS Trust; Queen Elizabeth University Hospital, NHS Greater Glasgow and Clyde; and North Tyneside General Hospital, Northumbria Healthcare NHS Foundation Trust.

Participants

770 participants aged 18 years or older with moderate or severe upper limb functional limitation from first-ever stroke.

Interventions

Participants randomised to one of three programmes provided over a 12-week period: robot-assisted training plus usual care; the EULT programme plus usual care or usual care.

Main economic outcome measures

Mean healthcare resource use; costs to the NHS and personal social services in 2018 pounds; utility scores based on EQ-5D-5L responses and quality-adjusted life years (QALYs). Cost-effectiveness reported as incremental cost per QALY and cost-effectiveness acceptability curves.

Results

At 6 months, on average usual care was the least costly option (£3785) followed by EULT (£4451) with robot-assisted training being the most costly (£5387). The mean difference in total costs between the usual care and robot-assisted training groups (£1601) was statistically significant (p<0.001). Mean QALYs were highest for the EULT group (0.23) but no evidence of a difference (p=0.995) was observed between the robot-assisted training (0.21) and usual care groups (0.21). The incremental cost per QALY at 6 months for participants randomised to EULT compared with usual care was £74 100. Cost-effectiveness acceptability curves showed that robot-assisted training was unlikely to be cost-effective and that EULT had a 19% chance of being cost-effective at the £20 000 willingness to pay (WTP) threshold. Usual care was most likely to be cost-effective at all the WTP values considered in the analysis.

Conclusions

The cost-effectiveness analysis suggested that neither robot-assisted training nor EULT, as delivered in this trial, were likely to be cost-effective at any of the cost per QALY thresholds considered.

Trial registration number

ISRCTN69371850.

SUBMITTER: Fernandez-Garcia C

PROVIDER: S-EPMC8154983 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundLoss of arm function is a common problem after stroke. Robot-assisted training might improve arm function and activities of daily living. We compared the clinical effectiveness of robot-assisted training using the MIT-Manus robotic gym with an enhanced upper limb therapy (EULT) programme based on repetitive functional task practice and with usual care.MethodsRATULS was a pragmatic, multicentre, randomised controlled trial done at four UK centres. Stroke patients aged at least 18 years with moderate or severe upper limb functional limitation, between 1 week and 5 years after their first stroke, were randomly assigned (1:1:1) to receive robot-assisted training, EULT, or usual care. Robot-assisted training and EULT were provided for 45 min, three times per week for 12 weeks. Randomisation was internet-based using permuted block sequences. Treatment allocation was masked from outcome assessors but not from participants or therapists. The primary outcome was upper limb function success (defined using the Action Research Arm Test [ARAT]) at 3 months. Analyses were done on an intention-to-treat basis. This study is registered with the ISRCTN registry, number ISRCTN69371850.FindingsBetween April 14, 2014, and April 30, 2018, 770 participants were enrolled and randomly assigned to either robot-assisted training (n=257), EULT (n=259), or usual care (n=254). The primary outcome of ARAT success was achieved by 103 (44%) of 232 patients in the robot-assisted training group, 118 (50%) of 234 in the EULT group, and 85 (42%) of 203 in the usual care group. Compared with usual care, robot-assisted training (adjusted odds ratio [aOR] 1·17 [98·3% CI 0·70-1·96]) and EULT (aOR 1·51 [0·90-2·51]) did not improve upper limb function; the effects of robot-assisted training did not differ from EULT (aOR 0·78 [0·48-1·27]). More participants in the robot-assisted training group (39 [15%] of 257) and EULT group (33 [13%] of 259) had serious adverse events than in the usual care group (20 [8%] of 254), but none were attributable to the intervention.InterpretationRobot-assisted training and EULT did not improve upper limb function after stroke compared with usual care for patients with moderate or severe upper limb functional limitation. These results do not support the use of robot-assisted training as provided in this trial in routine clinical practice.FundingNational Institute for Health Research Health Technology Assessment Programme.

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Project description:BackgroundUpper limb recovery is one of the main goals of post-stroke rehabilitation due to its importance for autonomy in Activities of Daily Living (ADL). Although the efficacy of upper limb Robot-assisted Therapy (RT) is well established in literature, the impact of the initial status of the patient on the effects of RT is still understudied. This paper aims to identify whether demographic, clinical and motor characteristics of stroke patients may influence the ability to independently perform ADL after RT.MethodsA retrospective study was conducted on sixty stroke patients who conducted planar upper limb goal-directed tasks with the InMotion 2.0 robot. The RT was administered 5 days/week for 4 weeks and each session lasted 45 minutes. The primary outcome measure was the Modified Barthel Index (BI), dichotomized into favourable (BI ≥75) and unfavourable (BI<75) outcomes. The potential predictors were the demographic and clinical records, and the following clinical assessment scores: Modified Ashworth Scale-Shoulder (MAS-S); Modified Ashworth Scale-Elbow (MAS-E); Fugl-Meyer Assessment Upper Extremity (FMA-UE); upper limb section of the Motricity Index (MIul); total passive Range Of Motion (pROM); and Box and Block Test (BBT).ResultsStatistical analysis showed that the BBT, FMA-UE and MIul scores were significant predictors of a favourable outcome in ADL. The cut-off scores of the independent variables were calculated (FMA-UE = 32; MIul = 48; BBT = 3) with respect to the dichotomic BI outcome. Their robustness was assessed with the Fragility Index (FMA-UE = 2; MIul = 3; BBT = 7), showing that BBT is the most robust predictor of favourable BI outcome. Moreover, subjects with all predictors higher than the cut-off scores had higher probability to increase their independence in ADL at the end of the therapy. Demographic records, spasticity and pROM were not identified as predictors.ConclusionStroke patients with greater manual dexterity and less impairment appear to have a higher probability of achieving clinically significant ADL outcomes after upper limb RT. The obtained results can help to optimise the management of RT treatment planning. Further studies on a larger number of patients with a long-term follow up are recommended in order to evaluate other potential predictors and to validate the results.