Table 3.
Outcome | Measurement tool | Frequency of measurement | Additional information | |
---|---|---|---|---|
Sensorimotor impairment | Ankle range of motion—dorsiflexion/plantarflexion and inversion/eversion | Electrogoniometer attached to lower leg (lateral border) contralesional side | Baseline Post-intervention 1-month follow-up |
Provides ratio-level data (cm) Intra-rater reliability r = 0.979 (54). |
Touch/pressure sensory threshold of plantar skin—under heel, hallux, 1st metatarsal phalangeal (MTP) joint and 5th MTP joint | Semmes Weinstein monofilaments (SWMs), using a bespoke algorithm (protocol in Supplementary Material) | Baseline After 5, 10, and 15 treatments, Post-intervention 1-month follow-up |
Provides ordinal data; filaments are numbered 1–20. One represents the largest force (300 g, 6.65) and 20 the smallest force (0.008 g, 1.65). Intra-rater reliability has been reported to be an r value of >0.9 when a specific protocol was followed (55). | |
Motor impairment (strength) of hip flexors, knee extensors and ankle dorsiflexors | Lower Extremity Motricity Index (LEMI) | Baseline After 5, 10, and 15 treatments, Post-intervention 1-month follow-up |
Provides interval level data. For individual actions (ankle dorsiflexion, knee extension and hip flexion) and all actions combined, Pearson correlations—good to excellent (r = 0.78–0.91), significant (p < 0.001) (56). Excellent test-retest intra-rater reliability of the Lower Extremity Motricity Index (LEMI) as a measure of strength (ICC = 0.93) (57). | |
Lower-limb function and balance | Walking ability | Functional Ambulation Category (FAC) | Baseline Post-intervention 1-month follow-up |
Provides categorical/nominal data. Valid and responsive, with excellent intra-rater reliability (Cohen k = 0.950) and inter-rater reliability (k = 0.905) in stroke survivors (52). |
Walking speed | Modified 5-metre walk test (5MWT) (videoed) | Baseline Post-intervention 1-month follow-up |
Provides ratio-level data (seconds). 5MWT was shown to have a standardised response mean (95%CI) of 1.22 (0.93, 1.50) at a comfortable pace and 1.00 (0.68, 1.30) at a maximum walking pace (58) | |
Pressure under the feet during stance phase of walking | TEKSCAN™ (F-Scan™) pressure insoles to record force-time integral (FTI) and centre of force velocity (COFV) in an AP direction | Baseline Post-intervention 1-month follow-up |
Provides ratio-level data force time integral (FTI) (N/sec) and (COFV) (cm/sec). Foot Scan pressure insole systems have been found generally to provide reliable force and pressure data (ICC > 0.75) (59). Pressure insoles (the Parotec System) have shown a very strong degree of association with an Advanced Mechanical Technology Inc. (AMTI) force plate when measuring COP in an AP direction with Pearson's correlation coefficients—greater than 0.90 for 67/67 trials (100%) (60). | |
Functional mobility | Modified Rivermead Mobility Index (mRMI) | Baseline Post-intervention 1-month follow-up |
Provides ordinal level data. Inter-rater reliability excellent = 0.98 (p < 0.001) (61). The minimal clinically relevant difference is 4.5 points. | |
Participants' perceptions of the acceptability of the interventions and outcome measures | Daily diaries and focus groups | Information recorded daily throughout the intervention period. Attendance at a focus group on completion of all the interventions and measures | Focus groups were used to provide an insight into the participants' trial experiences (62). Topic guides were used. A patient and public involvement and engagement (PPIE) advisor assisted with note-taking and summarising the information discussed at the end of each focus group. Braun and Clarke's (63) six-stage process for thematic analysis was broadly followed. |
5MWT, Five metre walk test; AP, Anterior-posterior; Cm, Centimetres; COFV, Centre of force velocity; COP, Centre of pressure; FAC, Functional Ambulation Category; FTI, Force time integral; ICC, Intraclass correlation co-efficient; LEMI, Lower Extremity Motricity Index; N/sec, Newtons per second; SWMs, Semmes Weinstein monofilaments.