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 Test7,8 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.[…]
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TBI Rehabilitation 