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. 2021 Jul 5;12:675106. doi: 10.3389/fneur.2021.675106

Table 3.

Summary of outcomes for the MoTaStim-Foot pilot study.

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.