Objective: To determine the clinical effectiveness and cost-effectiveness of robot-assisted training compared with an enhanced upper limb therapy (EULT) programme and with usual care.
Design: Pragmatic, observer-blind multicentre randomised controlled trial with embedded health economic and process evaluations.
Setting: Four NHS study centres.
Participants: Patients with moderate or severe upper limb functional limitation, between one week and five years following first stroke.
Interventions: Robot-assisted training using the MIT-Manus robotic gym system, an EULT programme comprised of repetitive functional task practice, and usual care.
Main outcome measures: The primary outcome was upper limb functional recovery “success” (assessed using the Action Research Arm Test) at three months. Secondary outcomes at three and six months were: Action Research Arm Test; upper limb impairment (Fugl-Meyer Assessment); activities of daily living (Barthel ADL Index); and quality of life (Stroke Impact Scale); resource utilisation costs; and quality adjusted life years.
Results: 770 participants were randomised (robot-assisted training 257; EULT 259; usual care 254). Upper limb functional recovery “success” was achieved in: robot-assisted training 103/232 (44%); EULT 118/234 (50%); and usual care 85/203 (42%). These differences were not statistically significant (adjusted Odds Ratio (98.33% CI): robot-assisted training v usual care 1·2 (0·7 to 2·0); EULT v usual care 1·5 (0·9 to 2·5); robot-assisted training v EULT 0·8 (0·5 to 1·3)).
The robot-assisted training group had less upper limb impairment (Fugl-Meyer Assessment motor subscale) compared to usual care at three and six months. The EULT group had less upper limb impairment (Fugl-Meyer Assessment motor subscale), improved mobility (Stroke Impact Scale mobility domain) and improved performance in activities of daily living (Stroke Impact Scale ADL domain) compared to usual care at three months. Compared to EULT, the robot-assisted training group performed less well in ADL (Stroke Impact Scale ADL domain) at three months. No other differences were clinically important and statistically significant. Participants found the robot-assisted training and EULT programmes acceptable. Neither intervention, as provided in this trial, was cost-effective at current NICE willingness to pay thresholds for a QALY.
Conclusions: Robot-assisted training did not improve upper limb function compared with usual care. Although robot-assisted training improved upper limb impairment, this did not translate into improvements in other outcomes. EULT resulted in potentially important improvements on upper limb impairment, performance in ADL, and mobility. Neither intervention was cost-effective.
Future work: Further research is needed to find ways to translate the improvements in upper limb impairment seen with robot-assisted training into improvements in upper limb function and ADL. Innovations to make rehabilitation programmes more cost-effective are required.
Limitations: Pragmatic inclusion criteria led to the recruitment of some participants with little prospect of recovery. The attrition rate was higher in UC compared to RT and EULT and differential attrition is a potential source of bias. Obtaining accurate information about the usual care which patients receive was a challenge.
Trial registration: ISRCTN69371850
Funding details: National Institute for Health Research Health Technology Assessment Programme (reference: 11/26/05).
|Number of pages||332|
|Journal||Health Technology Assessment|
|Publication status||Accepted/In press - 26 May 2020|
- robot-assisted training
- repetitive task practice
- randomised controlled trial
- process evaluation
- health economic evaluation
- upper limb/ arm