Preparing the published article.
Writing a Rehabilitation Robot Trial Protocol With Therapists
How rehabilitation and biomedical engineering teams can define tasks, scoring, supervision and stop criteria before a robot trial begins.
Define the Task Set Before Anyone Touches the Device
Before any purchase decision, agree with the rehabilitation team which tasks the device is expected to support, and write each one as a discrete trial item: a seated reaching task, a standing transfer practice sequence, a gait training block. For every item, record the starting position, the equipment set-up, the repetitions or the session duration the department intends to use, and the therapist skill level needed to supervise it. Ask the manufacturer's clinical representative to confirm in writing which items sit inside the intended use described in the manufacturer's instructions for use, and keep that answer in the trial file instead of relying on a demonstration. If a task cannot be described in one sentence, it is not ready to be tested.
Split the trial into two phases and state them in the protocol. Phase one is familiarisation: therapists operate the device without patients, learning the set-up sequence, the emergency stop and the limits of permitted movement. Phase two is supervised use with patients who meet the inclusion criteria the department has already agreed. Record the date each therapist completed familiarisation, because a result produced by an untrained operator describes the operator rather than the device.
List the questions the assessor must answer before the session starts: is the participant within the agreed criteria, is the set-up checklist complete, is a second trained person available, and is the planned task set identical to the one recorded for earlier sessions? Date and initial any change to the task set between sessions, so a later reader can see why the comparison is no longer like for like.
Scoring, Supervision and Stop Criteria in Writing
Choose the scoring method before the first session and keep it fixed for the whole trial. A simple ordinal scale applied by the same assessor is easier to defend than a detailed instrument that different assessors apply differently. Document who scores, when scoring happens, whether the participant or the therapist provides a rating, and how disagreement between two assessors is resolved. Store blank and completed forms together so an auditor can reconstruct any single session.
Supervision ratios belong in the protocol as a number, not an expectation. State how many trained staff must be present for each task item, what each person is responsible for, and who is authorised to stop the session. Name individual roles rather than departments, and record a deputy for each role so the trial does not stall when one person is on leave.
Stop criteria should be written as observable events, not as clinical judgements. Events worth listing include the participant asking to stop, the participant unable to maintain the agreed starting position, the device reporting a condition the operator cannot clear using the manufacturer's instructions for use, or the supervising therapist judging that the task is no longer performed as planned. For each event, record what happens next: the session ends, the device leaves service, biomedical engineering is contacted, an incident note is opened. Everyone in the trial should be able to state these rules without consulting the document.
What to Capture After Each Session and How to Decide
Agree on a one-page session record and resist adding fields later. The fields that carry the most weight are the date and start time, the device identification and software version shown on the device, the task items attempted, the score, the staff present, any deviation from the protocol, and any technical event with the time it occurred. Device identification matters because a trial result attaches to one asset, not to a model name.
Keep a parallel technical log held by biomedical engineering. When a therapist reports a fault or an unexpected behaviour, the engineering log should record the exact message displayed, what the operator did immediately beforehand, whether the event was reproducible, and what was done to the device afterwards. Two logs matched by date and time turn opinions into evidence.
Set the decision points in advance: a review date, the measures to be reviewed, and who must be present. Before the review, ask three questions. Was the task set completed for every participant who started? Are the recorded technical events consistent with the level of support the department can provide after purchase? Can the department reproduce the set-up and supervision pattern on an ordinary working day, without the manufacturer's representative present? A trial that only works with vendor support on site has not tested the department's own capability. Write the outcome, including any decision to extend, change or stop the trial, and file a copy with the rehabilitation lead and the procurement record.
Photo credits: the images in this article are licensed reference photographs of the relevant robot class, credited with author and licence in each caption; they are not photographs of the specific equipment discussed. Licence and author details are recorded with each image.