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. 2021 Jul 27;7(1):146.
doi: 10.1186/s40814-021-00886-0.

Feasibility of a specific task-oriented training versus its combination with manual therapy on balance and mobility in people post stroke at the chronic stage: study protocol for a pilot randomised controlled trial

Kristina Traxler  1   2 , Franz Schinabeck  3 , Eva Baum  1 , Edith Klotz  4 , Barbara Seebacher  5   6
Affiliations

Feasibility of a specific task-oriented training versus its combination with manual therapy on balance and mobility in people post stroke at the chronic stage: study protocol for a pilot randomised controlled trial

Kristina Traxler et al. Pilot Feasibility Stud. .

Abstract

Background: Large studies have shown that stroke is among the most relevant causes of acquired adult disability. Walking and balance impairment in stroke survivors often contribute to a restriction in daily activities and social participation. Task-oriented training (TOT) is an effective treatment strategy and manual therapy (MT) is used successfully to enhance ankle joint flexibility in this population. No study, however, has compared TOT against its combination with MT in a randomised controlled trial. Aims of this pilot study are therefore to explore the feasibility of a full-scale RCT using predefined feasibility criteria. Secondary aims are to explore the preliminary effects of specific TOT with a combined specific TOT-MT versus a control group in people post stroke.

Methods: This is a protocol of a 4-week prospective randomised controlled parallel pilot trial in people post stroke at the chronic stage with limited upper ankle joint mobility and an impairment in balance and mobility. At a German outpatient therapy centre using 1:1:1 allocation, 36 patients will be randomised into one of three groups: 15-min talocrural joint MT plus 30-min specific TOT (group A), 45-min specific TOT (group B), and controls (group C). Training will be goal-oriented including tasks that are based on daily activities and increased in difficulty utilising predefined progression criteria based on patients' skill levels. Interventions will be provided face-to-face 2 times per week, for 4 weeks, in addition to 20-min concurrent x4 weekly home-based training sessions. Data will be collected by blinded assessors at baseline, post-intervention and 4-week follow-up. The primary outcome will be feasibility assessed by recruitment, retention and adherence rates, compliance, adverse events, falls and the acceptability of the intervention. Secondary outcomes will be walking speed, single and dual tasking functional mobility, ankle range of motion, disability and health-related quality of life.

Discussion: Feasibility provided, results from this study will be used to calculate the sample size of a larger randomised controlled trial to investigate the effects of specific TOT and specific TOT-MT compared to a post stroke control group.

Trial registration: German Clinical Trials Register, DRKS00023068. Registered on 21.09.2020, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00023068 .

Keywords: Ankle joint; Manual therapy; Mobility limitation; Neurological physiotherapy; Postural balance; Range of motion; Stroke; Task-oriented training; Walking.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Flow diagram
Fig. 2
Fig. 2
Manual therapy techniques
See this image and copyright information in PMC

References

    1. van de Port IG, Kwakkel G, van Wijk I, Lindeman E. Susceptibility to deterioration of mobility long-term after stroke: a prospective cohort study. Stroke. 2006;37(1):167–171. doi: 10.1161/01.STR.0000195180.69904.f2. - DOI - PubMed
    1. Bower K, Thilarajah S, Pua YH, Williams G, Tan D, Mentiplay B, Denehy L, Clark R. Dynamic balance and instrumented gait variables are independent predictors of falls following stroke. J Neuroeng Rehabil. 2019;16(1):3. doi: 10.1186/s12984-018-0478-4. - DOI - PMC - PubMed
    1. Aho K, Harmsen P, Hatano S, Marquardsen J, Smirnov VE, Strasser T. Cerebrovascular disease in the community: results of a WHO collaborative study. Bull World Health Organ. 1980;58(1):113–130. - PMC - PubMed
    1. Jakubowitz E, Yao D, Windhagen H, Stukenborg-Colsman C, Thomann A, Daniilidis K. Treatment options for neurogenic drop foot: a systematic literature research. Z Orthop Unfall. 2017;155(4):402–408. doi: 10.1055/s-0043-100760. - DOI - PubMed
    1. Given JD, Dewald JP, Rymer WZ. Joint dependent passive stiffness in paretic and contralateral limbs of spastic patients with hemiparetic stroke. J Neurol Neurosurg Psychiatry. 1995;59(3):271–279. doi: 10.1136/jnnp.59.3.271. - DOI - PMC - PubMed

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