Aries, AM, Pomeroy, V, Sim, J ORCID: https://orcid.org/0000-0002-1816-1676, Read, S ORCID: https://orcid.org/0000-0002-1955-4519 and Hunter, SM ORCID: https://orcid.org/0000-0001-8844-6848 (2021) Sensory stimulation of the foot and ankle early post-stroke: a pilot and feasibility study. Frontiers in Neurology, 12 (675106).

[img]
Preview
Text
fneur-12-675106.pdf - Published Version
Available under License Creative Commons Attribution.

Download (3MB) | Preview

Abstract

Background: Somatosensory stimulation of the lower extremity could improve motor recovery and walking post-stroke. This pilot study investigated the feasibility of a subsequent randomized controlled trial (RCT) to determine whether task-specific gait training is more effective following either (a) intensive hands-on somatosensory stimulation or (b) wearing textured insoles.

Objectives: Determine recruitment and attrition rates, adherence to intervention, acceptability and viability of interventions and outcome measures, and estimate variance of outcome data to inform sample size for a subsequent RCT.

Methods: Design: randomized, single-blinded, mixed-methods pilot study.

Setting: In-patient rehabilitation ward and community.

Participants: n = 34, 18+years, 42–112 days following anterior or posterior circulation stroke, able to follow simple commands, able to walk independently pre-stroke, and providing informed consent.

Intervention: Twenty 30-min sessions of task-specific gait training (TSGT) (delivered over 6 weeks) in addition to either: (a) 30–60 min mobilization and tactile stimulation (MTS); or (b) unlimited textured insole (TI) wearing.

Outcomes: Ankle range of movement (electrogoniometer), touch-pressure sensory thresholds (Semmes Weinstein Monofilaments), motor impairment (Lower Extremity Motricity Index), walking ability and speed (Functional Ambulation Category, 5-m walk test, pressure insoles) and function (modified Rivermead Mobility Index), measured before randomization, post-intervention, and 1-month thereafter (follow-up). Adherence to allocated intervention and actual dose delivered (fidelity) were documented in case report forms and daily diaries. Focus groups further explored acceptability of interventions and study experience.

Analysis: Recruitment, attrition, and dose adherence rates were calculated as percentages of possible totals. Thematic analysis of daily diaries and focus group data was undertaken. Standard deviations of outcome measures were calculated and used to inform a sample size calculation.

Results: Recruitment, attrition, and adherence rates were 48.57, 5.88, and 96.88%, respectively. Focus groups, daily-diaries and case report forms indicated acceptability of interventions and outcome measures to participants. The 5-m walk was selected as primary outcome measure for a future trial [mean (SD) at end of intervention: 16.86 (11.24) MTS group and 21.56 (13.57) TI group]; sample size calculation indicated 60 participants are required per group.

Conclusion: Recruitment, attrition and adherence rates and acceptability of interventions and outcomes justify a subsequent powered RCT of MTS+TSGT compared with TI+TSGT.

Analysis: Recruitment, attrition, and dose adherence rates were calculated as percentages of possible totals. Thematic analysis of daily diaries and focus group data was undertaken. Standard deviations of outcome measures were calculated and used to inform a sample size calculation. Results: Recruitment, attrition, and adherence rates were 48.57, 5.88, and 96.88%, respectively. Focus groups, daily-diaries and case report forms indicated acceptability of interventions and outcome measures to participants. The 5-m walk was selected as primary outcome measure for a future trial [mean (SD) at end of intervention: 16.86 (11.24) MTS group and 21.56 (13.57) TI group]; sample size calculation indicated 60 participants are required per group.

Conclusion: Recruitment, attrition and adherence rates and acceptability of interventions and outcomes justify a subsequent powered RCT of MTS+TSGT compared with TI+TSGT.

Item Type: Article
Additional Information: © 2021 Aries, Pomeroy, Sim, Read and Hunter. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
Uncontrolled Keywords: stroke, rehabilitation, somatosensory stimulation, lower extremity, motor recovery, feasibility study, sensory retraining
Subjects: R Medicine > R Medicine (General)
R Medicine > RC Internal medicine > RC346 Neurology. Diseases of the nervous system, including speech disorders
Divisions: Faculty of Medicine and Health Sciences > School of Allied Health Professions
Depositing User: Symplectic
Date Deposited: 06 Jul 2021 15:33
Last Modified: 20 Aug 2021 13:23
URI: https://eprints.keele.ac.uk/id/eprint/9793

Actions (login required)

View Item View Item