Table 1 Template for Intervention Description and Replication (TIDieR) Checklist for the RATULS trial intervention treatments
Item | Intervention group | |
|---|---|---|
1. Brief name: ‘provide the name or phrase that describes the intervention’ | Robot-assisted training | Enhanced upper limb therapy |
2. Why?: ‘describe any rationale, theory, or goal of the elements essential to the intervention’ | Rationale for robot-assisted training: Increased intensity of rehabilitation is known to improve functional outcomes and moderate-quality evidence shows repetitive task training (when dose >20 h) increases arm function post stroke [7]. Robot-assisted training enables repetitive tasks to be undertaken in a highly consistent and controllable manner. A Cochrane systematic review of electromechanical and robot-assisted arm training after stroke reported outcomes from a total of 1160 patients who participated in 34 trials. Improvements in arm function (SMD 0.35, 95% confidence interval (CI), 0.18–0.51) and activities of daily living (SMD 0.37, 95% CI 0.11–0.64) were found in patients who received this treatment, but studies were often of low quality [8] Essential elements:  • Robotic device  • Repetitive task practice  • Increased intensity of training | Rationale for enhanced upper limb therapy: Increased intensity of rehabilitation is known to improve functional outcomes and moderate-quality evidence shows repetitive task training (when dose >20 h) increases arm function post stroke [7]. In addition, evidence suggests that patients benefit most from exercise programmes that involve functional tasks which are directly practised [46]. Motivation and engagement in therapy can be increased by goal-setting and monitoring goal achievement [47]. Essential elements:  • Repetitive functional task practice  • Patient-centred goal-setting  • Increased intensity of training |
3. What materials?: ‘describe any physical or informational materials used in the intervention, including those provided to participants or used in intervention delivery or in training of intervention providers. Provide information on where the materials can be accessed’ | InMotion robotic gym system is used (http://bionikusa.com/healthcarereform/upper-extremity-rehabilitiation/). The robotic gym consists of three robot modules to train the participant to use their upper limb:  • The shoulder-elbow module (InMotion ARMTM interactive therapy system). The participant moves their affected arm radially in eight different directions  • The wrist module (InMotion WRISTTM interactive therapy system). The movements of the participant’s wrist include flexion/extension, abduction/adduction and pronation/supination  • The hand module integrated onto the shoulder-elbow module (InMotion HANDTM). This encourages whole-arm movements that involve limb transport and grasp/release. Study-specific manuals describing robot-assisted training were produced and are used by staff delivering therapy. Study-specific documentation is used by therapists to record attendance at sessions. The robot software records data on the robot protocol used, duration of the sessions and the number of repetitions of upper limb movements undertaken. Staff delivering the robot-assisted training programme receive specific training | The enhanced upper limb therapy programme consists of repetitive functional task practice aimed at patient-centred goals. It has been developed from upper limb therapy programmes used in the Botulinum Toxin for the Upper Limb after Stroke (BoTULS) trial [27,28,29] and the Repetitive Arm Functional Tasks after Stroke (RAFTAS) project [30]. Study-specific manuals describing enhanced upper limb therapy were produced and are used by staff delivering therapy. Included in the manual is a list of potential goals and a description of suggested activities for each goal. Everyday items to enable functional task practice are provided. Study-specific documentation is used by therapists to record session attendance, session duration, the type and number of goals, the type of activity practice (‘whole-task’ or ‘part-task’) and number of repetitions of each task at each session. Goal attainment is documented at each review session. Staff delivering the enhanced upper limb therapy programme receive specific training |
4. What (procedures)?: ‘describe each of the procedures, activities and/or processes used in the intervention, including any enabling support activities’ | The robot-assisted training programme is divided into three consecutive blocks in order to integrate training with all three robot modules. Training sessions on all robot modules consist of high repetitions (aiming for >700 per session) of point-to-point movements. Block 1: block one lasts for 2 weeks and employs alternate training sessions with the shoulder-elbow module and the wrist module (three sessions on each robot module). The robot modules rhythmically move the participant’s upper limb to reach sequentially presented targets. Block 2: block 2 lasts for 6 weeks and employs alternate therapy sessions with the shoulder-and-elbow and the wrist modules (9 sessions on each robot module). The robot modules allow the participant to attempt to move towards sequentially presented targets unassisted but will assist if the participant needs help to reach the target. Block 3: block 3 lasts for 4 weeks and employs alternative therapy sessions with the hand module integrated on the shoulder-elbow module, and the wrist module (6 sessions on each module). As in block 2, the robot modules allow the participant to attempt to move towards the targets unassisted but will assist if the participant needs help to reach the target. For the therapy sessions with the hand module integrated on the shoulder-elbow module, targets are presented sequentially. For the therapy sessions with the wrist module, the targets are presented randomly. Evaluations of robotic kinematics (i.e. related to the movement pattern) and kinetics (i.e. related to the causes of movement) are incorporated into every third training session on each robot module. These evaluations monitor participant performance and are used to give feedback and encouragement | At the initial therapy session a brief assessment of the participant’s upper limb is performed and up to 4 upper limb rehabilitation goals of importance to the participant are agreed. The activities to practise to achieve these goals are subsequently determined. Activities are divided into two types: whole-task or a part-task. Whole-task activity practice consists of practising all of the components of the task in sequence. Part-task activity practice consists of practising a specific part of a task. Part-task practice is appropriate if a participant has difficulty with a specific part of a task as it will enable them to focus on this particular aspect while working towards completing the task as a whole. The order to practise the activities and the time spent on each activity is at the discretion of the therapist and participant according to the participant’s rehabilitation priorities. Where appropriate, participants undertake a brief warm up consisting of gentle stretching of the upper limb, prior to practising the chosen activities. At the second and subsequent therapy sessions, following a brief warm up (if necessary), practice of the selected activities continues, with the order to practise and time to spend on each activity being at local discretion. At therapy sessions 12 (end of week 4) and 24 (end of week 8), progress towards goals is reviewed. If the participant has achieved a goal, a new goal is set and a new activity to practise selected. If the participant finds a goal or activity too challenging or they are experiencing other problems, an alternative is chosen. At the final therapy session (36, end of week 12), practice of activities continues but part of the session is dedicated to ‘summing up’ with feedback to the participant about progress over the programme and advice about maintaining upper limb function in the longer term |
5. Who provided?: ‘for each category of intervention provider (for example, psychologist, nursing assistant) describe their expertise, background and any specific training given’ | A senior therapist (physiotherapist or occupational therapist) assesses each participant at their initial session on each robot module to ensure correct positioning and familiarisation with the robot. Therapy assistants (NHS band 3 or above) then deliver the robot-assisted training programme with senior supervision and support. A senior therapist reviews each participant at their last robot-assisted training session and provides feedback. All staff involved in the study received study-specific training. The senior therapists and therapy assistants delivering the robot-assisted training programme receive specific training in this aspect | A senior therapist (physiotherapist or occupational therapist) assesses each participant at their initial therapy session and they jointly select up to 4 upper limb rehabilitation goals and activities to practise. Therapy assistants (NHS band 3 or above) then deliver the enhanced upper limb therapy programme with senior supervision and support. A senior therapist reviews the participant every 4 weeks to plan/adjust the programme according to progress. A senior therapist reviews each participant at their last enhanced upper limb therapy session and provides feedback. All staff involved in the study received study-specific training The senior therapists and therapy assistants delivering enhanced upper limb therapy receive specific training in this aspect |
6. How?: ‘describe the modes of delivery (such as face to face or by some other mechanism, such as Internet or telephone) of the intervention and whether it was provided individually or in a group’ | 1:1 face-to-face delivery | 1:1 face-to-face delivery |
7. Where?: ‘describe the type of location(s) where the intervention occurred’ | NHS hospital facilities: dedicated therapy room | NHS hospital facilities: therapy gym or dedicated therapy room |
8. When and how much?: ‘describe the number of times the intervention was delivered and over what period of time including the number of sessions, their schedule, duration, intensity or dose’ | The robot-assisted training programme is provided for up to 45 min per day, 3 days per week for 12 weeks (a total of 36 therapy sessions), in addition to usual NHS care. One hour is allowed for each therapy session to facilitate preparation and set up | The enhanced upper limb therapy programme is provided for up to 45 min per day, 3 days per week for 12 weeks (a total of 36 therapy sessions), in addition to usual NHS care. One hour is allowed for each therapy session to facilitate preparation and set up |
9. Tailoring: ‘If intervention was planned to be personalised or adapted, then describe what, why, when and how’ | The use of the robot modules and order of blocks are standardised for all participants following the robot-assisted training programme. The only exception is in block 3 whereby if a participant is unable to use the hand module, the shoulder-elbow module is used on the ‘assist-as-needed’ random protocol (as described in section 4 above). The InMotion robotic gym system ‘assists-as-needed’ based on the specific performance of each patient. The system is designed to adjust the parameters (i.e. robot power and initiation of movement) as necessary during the therapy | The enhanced upper limb therapy programme is based on patient-centred goals. Up to 4 goals can be chosen. A senior therapist assesses/reviews each participant at baseline, 4, 8 and 12 weeks and plans/adjusts the programme according to progress. The therapists are also able to tailor the specifics of each activity practised to the ability of the participant, taking into consideration a range of upper limb parameters (i.e. sensation and proprioception, range of motion, strengths and coordination), other functions (including sitting balance, visuo-spatial awareness, vision), as well as the person’s cognitive and emotional status, communication skills and level of motivation |
10. Modifications: ‘If intervention was modified during the course of the study, describe the changes what, why, when and how’ | There have been no modifications to the interventions to date | |
11. How well (planned)?: ‘If intervention adherence or fidelity was assessed, describe how and by whom, and if any strategies were used to maintain or improve fidelity, describe them’ | Therapists/therapy assistants complete a robot-assisted training checklist to document attendance at sessions. The robot software records data on the robot protocol used, duration of the sessions and the number of repetitions of upper limb movements undertaken. Data from training sessions are periodically reviewed to monitor intervention adherence and feedback is provided to therapy staff delivering the intervention | Therapists/therapy assistants record session attendance, session duration, the type and number of goals, the type of activity practice (whole-task or part-task) and number of repetitions of each task at each session. Goal attainment is documented at each review session. Data from therapy sessions are periodically reviewed to monitor intervention adherence and feedback is provided to therapy staff delivering the intervention |
12. How well (actual)?: ‘If intervention adherence or fidelity was assessed, describe the extent to which the intervention was delivered as planned’ | Unable to address until completion of study | |