A physiotherapy trial is judged on two things: what the outcome assessor measured and what treatment each person actually received. Capture records both in one study, with blinded assessor roles, session logs, participant-reported function and one audit trail.
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Session delivered
Session date
Duration of supervised treatment
Components delivered
Protocol adaptation needed
Record why in the next field
Reason for adaptation
What to know first
The problem
A drug trial hands out an identical tablet. A physiotherapy trial hands out a conversation, a progression of exercises, a set of hands and a home programme, and then asks whether it worked. The therapist adapts load to the person in front of them. Participants in the same arm can receive visibly different treatment, on purpose, within the protocol. That is a strength of the intervention and a headache for the dataset.
Three data problems follow. First, who measured what: the therapist who treats should not be the person who records the primary outcome, so the system needs separate assessor and therapist roles. Second, what was delivered: without session records, a null result cannot be separated from an intervention that was never given as designed. Third, where it happened: many trials run across several clinics, each with its own habits, so site-level differences have to be visible in the data rather than discovered at analysis.
Spreadsheets handle the first sentence of a protocol and break on the second. They do not enforce who can see the allocation, they do not keep a history of who changed a walking distance, and they merge badly when five clinics each edit their own copy. A purpose-built EDC with an eCRF builder closes those gaps without asking a physiotherapy research team to become database programmers.
| Treating physio | Outcome assessor | Statistician (blinded) | |
|---|---|---|---|
| Allocation (arm) | |||
| Session log forms | |||
| Outcome test forms | |||
| Participant diary data |
Blinded assessment
Assign outcome assessors a blinded role. Blinded roles never receive treatment-arm values, because masked database views and row-level security remove them at the data layer. The audit trail still records who entered each outcome and when.
Study coordinator
Subject 01-004
Randomized · R-0012
KitK-10418
Arm columnNot sent
Unblinded administrator
Subject 01-004
Randomized · R-0012
KitK-10418
Arm columnA
Same subject, same screen. The arm never reaches blinded roles.
What to capture
General practice for exercise and manual therapy trials. Measures named are examples; licensed instruments keep their own licence terms and are not reproduced here.
| Data stream | Examples | Who records it | How in Capture |
|---|---|---|---|
| Assessor-measured outcomes | Timed walk or sit-to-stand, range of motion, grip strength | Blinded assessor at the clinic | Site form with number fields, units and range checks |
| Participant-reported outcomes | Pain intensity, function, global change, quality of life | Participant on their phone | ePRO questionnaires with scheduled tasks |
| Treatment delivered | Sessions, minutes, components, adaptations, adverse reactions | Treating physiotherapist | Repeating session form per visit |
| Home programme | Sessions done, difficulty, barriers | Participant | Short diary; see patient diary software |
Licence terms for questionnaires stay with your study documents. Capture can record licence details on a patient questionnaire but does not verify them or supply instrument wording.
Create both in the free sandbox, give each a different role and see what each user can and cannot see. No credit card, no time limit.
Reporting standards
Journals expect non-drug interventions to be described well enough to be repeated. Two reporting aids are widely used: the TIDieR checklist for describing interventions (what, who, how, where, when, how much, tailoring, modifications and how well it was delivered) and the CONSORT extension for non-pharmacological treatments. Neither is a software requirement, but each tells you which fields to collect while the trial is running, because you cannot reconstruct session duration or modifications from memory a year later.
Turn that into form design. A session form with duration, components delivered and an adaptation flag with a reason answers the "how much, tailoring and modifications" items. A participant diary answers "how well" from the participant's side. A short deviation field on the same form captures sessions that missed the protocol, which feeds the protocol deviation tracking you will need anyway.
Therapist effects are the other quiet issue. If three physiotherapists deliver the intervention, the analysis may need to adjust for who treated whom. Record the treating therapist as a coded field on every session and the data is ready for that analysis. If clinics are the unit of randomisation, see EDC for cluster randomized trials and the cluster sample size calculator.
Dose is what was prescribed. Adherence is what the participant did. Fidelity is whether the therapist delivered what the protocol describes. A trial that records only attendance cannot tell them apart. Three short fields, one per concept, usually settle it.
Multi-clinic trials
Physiotherapy research often runs across community clinics and hospital departments with small teams. Capture supports multi-site operation with site-level participant numbering, a site coordinator portal and by-site filters and exports, so differences between clinics are visible early.
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Getting started
Baseline, end of treatment, follow-ups. Note which are assessor visits and which are participant-reported only.
Upload the protocol and let the AI study builder draft the visit schedule and forms, or build them from the template library. Nothing is saved without your review.
Create the blinded assessor role, add range checks to test values and make the session form mandatory at treatment visits.
In the sandbox, play a therapist, an assessor and a participant. Confirm the assessor never sees the arm.
Approve the forms, enrol participants and watch missed sessions and overdue outcomes on the dashboard.
Teams use a spreadsheet, REDCap, a commercial EDC or a self-serve platform. Capture is a self-serve EDC with ePRO and randomization that handles assessor forms, session logs and participant diaries in one study, with a free sandbox to test the design first.
Give assessors a blinded role. In Capture, blinded roles never receive treatment-arm values; this is enforced by masked database views and row-level security, not only by hiding a field in the interface.
Yes. Build a repeating session form for the physiotherapist with date, duration, components, adaptations and the treating therapist, and add a short participant diary for the home programme.
Yes. ePRO questionnaires run on the participant's phone, and QR-code enrollment needs no app install.
No. Capture does not supply licensed instruments or their wording and does not verify licences. You can record licence details on a patient questionnaire; the licence itself stays with your study documents.
Yes. Capture supports multiple sites with site-level participant numbering, a site coordinator portal and by-site filtering and exports.
No. Capture is suitable for Phase 1, 2 and 3 style studies; physiotherapy trials of any size can use it, and the sandbox lets you test the design before committing.
Open the free sandbox, build a session form and an assessor form, enter sample data and test the roles. It has every feature, no credit card and no time limit; you pay only when you go live with real participants.
Keep exploring
Software for rehabilitation research
The wider rehabilitation research view.
Blinded and unblinded role management
How blinded roles work.
Patient diary software
Home programme diaries on phones.
EDC for exercise intervention trials
Training and exercise studies.
EDC for cluster randomized trials
When the clinic is randomised.
Protocol deviation tracking
Missed or modified sessions.
Free sandbox with every feature. Build the session log, the assessor form and the roles, and try them with sample data.