I bet this didn't show results because not enough repetitions were done. They mention intensity of training, 20 hours needed from a Cochrane review but don't assign failure to what they even mention. Bad analysis and research, their mentors and senior researchers should have caught that.
Robot assisted training for the upper limb after stroke (RATULS): a multicentre randomised controlled trial
- et al.
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.
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.
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.
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.
,
Intensity of therapy is also important; a Cochrane overview
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.
,
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
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