Table 10.

Planning a future trial: pilot study aspects considered within a traffic light system.

Traffic light	Aspect of pilot study	Considerations/changes required
	Outcome measures	mRMI—Ceiling effect evident and access to stairs issues—not meeting requirements of next trial.
		Ankle range of movement with electrogoniometry—not to be used unless there is further reliability testing. It is inappropriate to measure just the ankle range of movement and not the knee. Use of the tibia to vertical angle (85) may be more clinically useful and could be piloted for further studies.
	Study Management Group	This worked well, but independent steering and data monitoring committees required in future.
	Case report forms	Consider electronic case report forms for future trials.
	Recruitment procedures	Consider involvement of Clinical Research Network to assist in recruitment for future studies.
	Exclusion criteria	Consider whether botulinum toxin should be an exclusion to the trial or not.
	NIHSS	Score four points less for left hemisphere stroke than right; NIHSS useful; staff training is essential.
	Randomization procedures	Consider issue of posterior circulation strokes for randomization in future trial.
	Monitoring length of time wearing TIs	Consider mechanism for recording the length of time TIs are worn if no daily diaries.
	Outcome measures	LEMI—suitable and quick to administer, must specify removal of footwear prior to testing.
		Functional Ambulation Category—Consider access to stairs and inclines for accurate scoring.
		Pressure insoles—Consider purchasing a wireless system to increase the safety of participants and speed of testing. Need to build in time for setting up the equipment and calibrating the insoles.
		Sensory threshold testing with SWMs—Due to the lack of significant results for all but the hallux point in the TI group and time to test, consider applicability for future trials or just test one point.
	Proprioception	Plan to include an outcome measure for assessing proprioception in future trials.
	Patient and public involvement and engagement	The PPIE within MoTaStim-Foot was thorough and beneficial; plan this level of PPIE in future.
	Screening	Step test: This worked well, screening out stroke survivors who functioned at too high a level.
		Ability to follow simple commands screening test: This served its purpose. All participants recruited had capacity to consent and follow therapy instructions.
	Interventions	Thorough training is required for research therapists to ensure adherence all intervention protocols.
	5MWT or 10MWT	Video enabled assessment of assistance to walk/aide. Plan: 1–2 m at start and end of the 5MWT/10MWT.
	Blinded Assessment	This worked well and should be continued for future trials.
	Usual care therapy treatment record	It is important to keep a record of the NHS therapy intervention received.
	Pain/fatigue assessment process and form	This is important to use to monitor pain and fatigue.
	Focus groups exploring participants' perceptions	Hearing participants' opinions is important in a therapy trial because they play an active part in rehabilitation. It also allows for triangulation of methods.
	Focus group schedules	Will need to be adapted as required for a future trial.

LEMI, Lower Extremity Motricity Index; NIHSS, National Institutes of Health Stroke Scale; mRMI, modified Rivermead Motricity Index; NHS, National Health Service; PPIE, Patient and public involvement and engagement; SWMs, Semmes Weinstein monofilaments; TIs, Textured insoles; 5 or 10MWT, 5 or 10 metre walk test. Red = Should not be retained; Amber = Can be retained with some changes; Green = Can be retained without changes.