Research type · RehabilitationUpdated September 28, 2026

Clinical trial software for rehabilitation research

Rehabilitation trials measure what people can do: walk, balance, climb stairs, get back to work. Capture records therapist-run performance tests, functional scales and home exercise adherence in one study, with blinded assessors and no setup fee for academic budgets.

  • Performance tests as site forms
  • Home exercise diaries
  • PROMIS short forms in the library

Free sandbox · No credit card · 21 CFR Part 11 aligned

Six-minute walk test · Week 12
Subject 001-0027 · Blinded outcome assessorDraft

Distance walked

412m

Number of rests

1

Walking aid used

Single-point cane

Dyspnoea at end of test (Borg CR10)

012345678910

SpO₂ after test

96%
Assessor recorded in the audit trail

What matters in rehabilitation trials

  • Outcomes are largely performance-based (timed walks, balance tests, strength) or functional scales rated by clinicians, supported by participant-reported function and quality of life.
  • Treating therapists usually know the allocation, so trials rely on blinded outcome assessors. The data system should show who assessed each outcome.
  • Much of the intervention happens at home. Exercise adherence diaries show whether participants received the dose the protocol intended.
  • Many rehab trials are academic, pragmatic and multi-site, with modest budgets and therapists as site staff rather than full-time research coordinators.
  • Capture's library includes PROMIS Physical Function, Fatigue and Cognitive Function short forms with licence tracking.

Outcomes

Measuring function, not just symptoms

Rehabilitation research asks whether an intervention helps people function: walk further, fall less, return to daily activities. That means outcomes such as the six-minute walk test, timed up and go, balance scales, grip strength and activities of daily living scales, plus participant-reported function. Each has a standard administration protocol, and variations in how a test is done (the length of the corridor, the encouragement given, the walking aid used) change the result.

In Capture, performance tests are built as site forms completed by the assessor, a performance outcome in eCOA terms. Each measured value is a number field with its unit and a plausibility range, and the context that affects interpretation (walking aid, rests, oxygen use) is recorded alongside the result rather than in a comment box.

Blinded assessors

Therapists delivering an exercise or device intervention cannot be blinded, so outcome assessment is usually done by a separate assessor who does not know the allocation. Assign assessors a role without access to treatment allocation, and use the field-level audit trail to confirm that outcome forms were completed by assessors rather than treating therapists.

Participant-reported function

Performance tests show capacity in the clinic; participant-reported measures show function in daily life. PROMIS short forms from the Capture library, or condition-specific questionnaires, can run on participants' phones between visits.

PRO

Patient-reported

Participant, own phone

ObsRO

Observer-reported

Caregiver

ClinRO

Clinician-reported

Site staff, clinic tablet

PerfO

Performance outcome

Site-run test, e.g. chair rise

Home programs

See whether the home exercise dose was delivered

A home exercise program only works if it is done. A short daily or weekly diary on the participant's phone records sessions completed, duration and difficulty, with reminders and a completion window. Adherence data then sits next to outcomes, so you can analyse dose as well as allocation.

  • Recurring diary in the phone browser, no app.
  • Reminders that respect quiet hours.
  • Adherence and at-risk participants on the dashboard.
Patient diary software
Home exercise adherence · Intervention arm

Sessions planned

36

Median completed

29

Below 50%

4

Weeks 1 to 411/12
Weeks 5 to 810/12
Weeks 9 to 128/12

Typical late drop-off

Dose delivered, not just dose prescribed

Academic budgets

Built for therapist-led, grant-funded studies

Many rehabilitation trials are run by clinical academics with therapists as site staff. Capture has no setup fee and no per-site fee; you build and test the full study free and pay only when it goes live. The AI Study Generator drafts the schedule and forms from your protocol, so the build does not wait for a programmer.

  • Free sandbox with every feature.
  • No per-site fee for multi-centre networks.
  • Protocol to draft study in minutes.
EDC for academic clinical trials
app.capture.study · New study
Capture AI Study Generator: describe the study or upload a protocol to generate it

Build a walk test form and an exercise diary

Try both in the free sandbox and complete the diary on your phone.

Build your rehab study free

Common measures

Rehabilitation outcomes and how to capture them

MeasureTypeCapture as
Six-minute walk testPerformanceSite form: distance, rests, aid, exertion, oxygen saturation
Timed up and goPerformanceSite form: time in seconds, aid used
Balance scalesClinician-ratedSite form: one field per item, total derived in analysis
Grip strengthPerformanceSite form: repeated trials as table rows
Activities of daily living scalesClinician or participantSite form or ePRO depending on the instrument
PROMIS Physical FunctionParticipant-reportedePRO from the library, licence tracked
Exercise adherenceParticipant-reportedRecurring ePRO diary

Obtain instruments and any licences from their rights holders. Licence details can be recorded on each form.

Intervention fidelity

Recording what the therapy actually was

In drug trials the intervention is a tablet with a known dose. In rehabilitation trials it is a series of sessions delivered by different therapists, adapted to each participant's progress. Whether the intervention was delivered as intended (its fidelity) is part of the result, and reviewers increasingly expect it to be measured.

A short session log completed by the treating therapist after each session records what was delivered: duration, components, intensity and any reason a session was modified or missed. Combined with the participant's home exercise diary, it shows the dose actually received in both supervised and unsupervised parts of the programme. Because therapists are site staff, the log is a site form, attributed to the therapist in the audit trail, separate from the outcome forms completed by blinded assessors.

Multi-site and pragmatic rehab trials

Rehabilitation trials often run across many hospitals and community services, where research is not anyone's full-time job. Short forms, clear visit windows and no per-site fees make it practical to include smaller services. See pragmatic clinical trials for design considerations.

Study build

Rehabilitation study build checklist

Test protocols standardised

Course length, instructions and encouragement defined for each performance test.

Assessors blinded

Outcome assessors separate from treating therapists, with roles to match.

Fidelity log

Therapist session log for supervised sessions.

Home adherence diary

Short recurring diary with reminders.

Licences recorded

For any licensed functional scales and PROMIS forms.

Context captured

Walking aids, rests and oxygen use recorded with results.

FAQ

Questions teams ask before they switch

Something not covered here? Ask us directly.

What outcomes do rehabilitation trials use?

Performance tests such as the six-minute walk and timed up and go, clinician-rated function and balance scales, and participant-reported function and quality of life.

How are performance tests recorded?

As site forms completed by the assessor, with numeric results, units, plausibility ranges and the context that affects interpretation.

Can outcome assessors be blinded?

Assign assessors a role without access to treatment allocation, and use the audit trail to confirm who completed each outcome form.

Can participants log home exercise?

Yes. A recurring diary in the phone browser records sessions, with reminders and adherence shown on the dashboard.

Is Capture affordable for grant-funded studies?

There is no setup or per-site fee, and the full study can be built and tested free before going live.

Are PROMIS measures available?

Yes. PROMIS Physical Function 8b, Fatigue 8a and Cognitive Function 8a are in the library with licence tracking.

Measure what participants can do

Performance tests, diaries and PROMIS in one study. Free sandbox.

Build your rehab study free