[ARTICLE] Evaluation of the enhanced upper limb therapy programme within the Robot-Assisted Training for the Upper Limb after Stroke trial: descriptive analysis of intervention fidelity, goal selection and goal achievement – Full Text

Abstract

Objective:

To report the fidelity of the enhanced upper limb therapy programme within the Robot-Assisted Training for the Upper Limb after stroke (RATULS) randomized controlled trial, the types of goals selected and the proportion of goals achieved.

Design:

Descriptive analysis of data on fidelity, goal selection and achievement from an intervention group within a randomized controlled trial.

Setting:

Out-patient stroke rehabilitation within four UK NHS centres.

Subjects:

259 participants with moderate-severe upper limb activity limitation (Action Research Arm Test 0–39) between one week and five years post first stroke.

Intervention:

The enhanced upper limb therapy programme aimed to provide 36 one-hour sessions, including 45 minutes of face-to-face therapy focusing on personal goals, over 12 weeks.

Results:

7877/9324 (84%) sessions were attended; a median of 34 [IQR 29–36] per participant. A median of 127 [IQR 70–190] repetitions were achieved per participant per session attended. Based upon the Canadian Occupational Performance Measure, goal categories were: self-care 1449/2664 (54%); productivity 374/2664 (14%); leisure 180/2664 (7%) and ‘other’ 661/2664 (25%). For the 2051/2664 goals for which data were available, 1287 (51%) were achieved, ranging between 27% by participants more than 12 months post stroke with baseline Action Research Arm Test scores 0–7, and 88% by those less than three months after stroke with scores 8–19.

Conclusions:

Intervention fidelity was high. Goals relating to self-care were most commonly selected. The proportion of goals achieved varied, depending on time post stroke and baseline arm activity limitation.

Introduction

Up to 80% of stroke survivors have difficulties using their affected arm in daily activities,¹ which often persist in the longer term, impacting on the ability to engage social roles and on autonomy.² There is a need for further high quality evidence to support interventions to improve arm function after stroke.^1,3,4 Repetitive functional task training has shown promise for improving arm function,^3,5 and therefore further trials of this type of intervention are particularly important. The Robot-Assisted Training for the Upper Limb after Stroke (RATULS) randomized controlled trial, the largest of its kind to date (n = 770), was published recently.⁶ Participants were randomized to receive robot-assisted training, an enhanced upper limb therapy programme (where repetitive functional task practice focused on personal goals), or usual care.⁶ There was little evidence of a difference in the primary outcome of arm activity limitation (i.e. success in attaining pre-specified improvement in the Action Research Arm Test^7,8 score at three months) between randomization groups. However, participants who were randomized to receive the enhanced upper limb therapy programme performed significantly better in a number of secondary outcomes when compared to those who received usual care. Clinically important benefits at the end of the three month intervention period were observed in measures of impairment (Fugl-Meyer Assessment Motor Score),^8,9 activities of daily living and mobility (Stroke Impact Scale).¹⁰ Additionally, there were statistically significant improvements which were not considered clinically important, as the confidence intervals did not include values that are currently deemed to be Minimum Clinically Important Differences. These statistically significant improvements were in measures of arm function (Action Research Arm Test), hand function (Stroke Impact Scale),¹⁰ and activities of daily living (Barthel Activity of Daily Living Index)¹¹ – with the latter continuing to 6 months follow-up. Participants randomized to receive the enhanced upper limb therapy programme also performed significantly better than those randomized to receive robot-assisted training in measures of activities of daily living at three months (Stroke Impact Scale¹⁰ and Barthel Index¹¹) but these improvements also did not reach the threshold for being considered clinically important.⁶

It is important that the development and fidelity of interventions are fully reported to enable the results of a trial to be interpreted, and for the intervention to be replicable in routine clinical practice or future research. However, stroke rehabilitation trials often fall short in terms of reporting these aspects.^12,13 The development and description of the enhanced upper limb therapy programme followed the Template for Intervention Description and Replication (TIDieR) framework,¹² and the planned delivery of the intervention (TIDieR items 1–11) has been reported.¹⁴ The aim of this paper is to report the intervention fidelity (TIDieR item 12) and a descriptive analysis of the types of personal goals selected and the proportion achieved.[…]

Continue —-> https://journals.sagepub.com/doi/full/10.1177/0269215520953833

[WEB SITE] RATULS Trial Using BIONIK InMotion Researches Robot-Assisted Stroke Therapy

A landmark Robot Assisted Training for the Upper Limb after Stroke (RATULS) trial utilizing BIONIK Laboratories Corp’s InMotion Robotic Therapy Systems was completed recently, the Toronto-based company announces.

The RATULS trial, which began in 2014 and was completed at the end of 2018, compared the clinical effectiveness of robot-assisted training, enhanced upper limb therapy, and usual care for patients with moderate or severe upper limb functional limitation.

Results were presented recently at the European Stroke Organisation Conference (ESOC) in Milan, Italy, and published in The Lancet.

“We are pleased that the RATULS trial confirmed the finding of previous research studies which demonstrated that robot-assisted therapy improved upper limb impairment when compared with conventional care methods for stroke victims.

“The trial’s finding that robotic therapy is the only therapy to statistically maintain a significant impairment advantage at six months after treatment is a strong signal that robotic therapy is critical for achieving positive patient outcomes,” says Dr Eric Dusseux, CEO, BIONIK Laboratories, in a media release.

For the RATULS trial, the primary outcome for upper limb success was determined by Action Research Arm Test (ARAT), with four distinct success criteria that varied according to baseline severity, not used previously and developed by the RATULS trial team.

Although the findings demonstrated that robot-assisted therapy improved upper limb impairment, using this ARAT measurement, the trial was unable to conclude that robot-assisted therapy or enhanced upper limb therapy resulted in improved upper limb functionality after stroke compared with usual care provided to patients with stroke-related upper limb functional limitation. The attrition rate was also drastically reduced in patient population following either robotic therapy or enhanced upper limb therapy versus usual care only, and most of the withdrawals before 3 months in usual care were due to disappointment with treatment allocation, the release explains.

“The combination of evidenced-based medicine and real-world clinical feedback have led to the release of substantially improved versions of the InMotion ARM Robotic Therapy System announced in early 2018, and the InMotion ARM/HAND Robotic Therapy System announced beginning of 2019. These versions of our products include enhanced software applications with patient-centric configurable protocols to assist the therapist in providing specialized treatment of stroke and traumatic brain injury.”

[Source(s): BIONIK Laboratories Corp, Business Wire]

 

via RATULS Trial Using BIONIK InMotion Researches Robot-Assisted Stroke Therapy – Rehab Managment

[ARTICLE] Robot assisted training for the upper limb after stroke (RATULS): a multicentre randomised controlled trial – Full Text

Summary

Background

Loss 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.

Methods

RATULS 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.

Findings

Between 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.

Interpretation

Robot-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.

Funding

National Institute for Health Research Health Technology Assessment Programme.

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Introduction

Upper limb problems commonly occur after a stroke, comprising loss of movement, coordination, sensation, and dexterity, which lead to difficulties with activities of daily living (ADL) such as washing and dressing. About 80% of people with acute stroke have upper limb motor impairment, and of those with reduced arm function early after stroke, 50% still have problems after 4 years.1

The strongest predictor of recovery is severity of initial neurological deficit; patients with severe initial upper limb impairment are unlikely to recover arm function, with clear impact upon their quality of life. Patients report that loss of arm function is one of the most distressing long-term consequences of stroke. Improving upper limb function has been identified as a top ten research priority by stroke survivors, carers, and clinicians.2

How to optimise stroke patients’ upper limb recovery is unclear. Systematic reviews of therapy interventions suggest that patients benefit from therapy programmes in which they practise tasks directly rather than from interventions that focus on impairments.3^, 4 Intensity of therapy is also important; a Cochrane overview4 of systematic reviews found moderate quality Grading of Recommendations, Assessment, Development and Evaluations evidence that arm function after a stroke can be improved by the provision of at least 20 h of additional repetitive task training.

Robot-assisted arm training has shown promise for improving ADL, arm function, and arm muscle strength after stroke.5^, 6 However, studies vary in patient characteristics, device used, duration and amount of training, control group, and outcome measures used. The benefits of robot-assisted arm training over conventional therapy of the same frequency and duration have not been shown.7

[…]

Continue —> Robot assisted training for the upper limb after stroke (RATULS): a multicentre randomised controlled trial – The Lancet

Figure 2ARAT success, total ARAT score, and Fugl–Meyer motor score at baseline, 3 months, and 6 months