Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2019

Open Access 01-12-2019 | Stroke | Study protocol

Upper limb strength training in subacute stroke patients: study protocol of a randomised controlled trial

Authors: Susan Högg, Manfred Holzgraefe, Insa Wingendorf, Jan Mehrholz, Christoph Herrmann, Mark Obermann

Published in: Trials | Issue 1/2019

Login to get access

Abstract

Background

Stroke patients are often affected by arm paresis, have functional impairments and receive help from professional or informal caregivers. Progressive resistance training is a common intervention for functional impairments after paresis. Randomised controlled trials (RCT) showed benefits for functional recovery after resistance training. However, there is a lack of evidence for strength training in subacute stroke patients. The aim of this study is to investigate safety and effectiveness of arm strength training in subacute stroke patients.

Methods

We will conduct a prospective, assessor-blinded RCT of people with subacute stroke. We will randomly assign patients to one of two parallel groups in a 1:1 ratio and will use concealed allocation. The intervention group will receive, in addition to standard treatment, high-intensity arm training (three times per week, over three weeks; 60 min each session; with a total of nine additional sessions). The control group will receive, in addition to standard treatment, low-intensity arm training (same quantity, frequency and treatment time as the intervention group). Standard treatment for the affected arm includes mobilisation, stretching, therapeutic positioning, arm and hand motor training, strengthening exercises, mechanical assisted training, functional training and task-oriented training. The primary efficacy endpoint will be grip strength. Secondary outcome measures will be Modified Ashworth Scale, Motricity Index, Fugl-Meyer Assessment for the upper limb, Box and Block Test and Goal Attainment Scale for individual participatory goals. We will measure primary and secondary outcomes with blinded assessors at baseline and immediately after three weeks of additional therapy. Based on our sample size calculation, 78 patients will be recruited from our rehabilitation hospital in two and a half years. Drop-out rates and adverse events will be systematically recorded.

Discussion

This study attempts to close the evidence gap for effects of arm strength training in subacute stroke patients. The results of this trial will provide robust evidence for effects and safety of high-intensity arm training for people with stroke.

Trial registration

German Clinical Trials Register, DRKS00012484. Registered on 26 May 2017.
Appendix
Available only for authorised users
Literature
1.
Lawrence ES, Coshall C, Dundas R, Stewart J, Rudd AG, Howard R, et al. Estimates of the prevalence of acute stroke impairments and disability in a multiethnic population. Stroke. 2001;32:1279–84.CrossRef
2.
Bohannon RW, Warren ME, Cogman KA. Motor variables correlated with the hand-to-mouth maneuver in stroke patients. Arch Phys Med Rehabil. 1991;72:682–4.CrossRef
3.
Bourbonnais D, Vanden Noven S. More on muscle strength measurement. Phys Ther. 1989;69:990–4.CrossRef
4.
Argyrides A, Paley L, Kavanagh M, Vestesson E, Hoffman A, Rudd A. Sentinel Stroke National Audit Programme (SSNAP); 2015. p. 84.
5.
Pollock A, Farmer SE, Brady MC, Langhorne P, Mead GE, Mehrholz J, et al. Interventions for improving upper limb function after stroke. Cochrane Database Syst Rev. 2014;11:CD010820.
6.
Sterr A, Freivogel S. Intensive training in chronic upper limb hemiparesis does not increase spasticity or synergies. Neurology. 2004;63:2176–7.CrossRef
7.
Kwakkel G, van Peppen R, Wagenaar RC, Wood Dauphinee S, Richards C, Ashburn A, et al. Effects of augmented exercise therapy time after stroke: a meta-analysis. Stroke. 2004;35:2529–39.CrossRef
8.
Prange GB, Kottink AIR, Buurke JH, Eckhardt MMEM, BJv K-R, Ribbers GM, et al. The effect of arm support combined with rehabilitation games on upper-extremity function in subacute stroke: a randomized controlled trial. Neurorehabil Neural Repair. 2015;29:174–82.CrossRef
9.
Chan IH, Fong KN, Chan DY, Wang AQ, Cheng EK, Chau PH, et al. Effects of arm weight support training to promote recovery of upper limb function for subacute patients after stroke with different levels of arm impairments. Biomed Res Int. 2016;2016:9346374.PubMedPubMedCentral
10.
Aidar FJ, de Oliveira RJ, Silva AJ, de Matos DG, Mazini Filho ML, Hickner RC, et al. The influence of resistance exercise training on the levels of anxiety in ischemic stroke. Stroke Res Treat. 2012;2012:298375.PubMedPubMedCentral
11.
da Silva PB, Antunes FN, Graef P, Cechetti F, Pagnussat Ade S. Strength training associated with task-oriented training to enhance upper-limb motor function in elderly patients with mild impairment after stroke: a randomized controlled trial. Am J Phys Med Rehabil. 2015;94:11–9.CrossRef
12.
Corti M, McGuirk TE, Wu SS, Patten C. Differential effects of power training versus functional task practice on compensation and restoration of arm function after stroke. Neurorehabil Neural Repair. 2012;26:842–54.CrossRef
13.
Fasoli SE, Krebs HI, Stein J, Frontera WR, Hogan N. Effects of robotic therapy on motor impairment and recovery in chronic stroke. Arch Phys Med Rehabil. 2003;84:477–82.CrossRef
14.
Lin CH, Chou LW, Luo HJ, Tsai PY, Lieu FK, Chiang SL, et al. Effects of computer-aided interlimb force coupling training on paretic hand and arm motor control following chronic stroke: a randomized controlled trial. PLoS One. 2015;10:e0131048.CrossRef
15.
Pang MY, Harris JE, Eng JJ. A community-based upper-extremity group exercise program improves motor function and performance of functional activities in chronic stroke: a randomized controlled trial. Arch Phys Med Rehabil. 2006;87:1–9.CrossRef
16.
Mares K, Cross J, Clark A, Vaughan S, Barton GR, Poland F, et al. Feasibility of a randomized controlled trial of functional strength training for people between six months and five years after stroke: FeSTivaLS trial. Trials. 2014;15:322.CrossRef
17.
Winstein CJ, Rose DK, Tan SM, Lewthwaite R, Chui HC, Azen SP. A randomized controlled comparison of upper-extremity rehabilitation strategies in acute stroke: A pilot study of immediate and long-term outcomes. Arch Phys Med Rehabil. 2004;85:620–8.CrossRef
18.
Donaldson C, Tallis R, Miller S, Sunderland A, Lemon R, Pomeroy V. Effects of conventional physical therapy and functional strength training on upper limb motor recovery after stroke: a randomized phase II study. Neurorehabil Neural Repair. 2009;23:389–97.CrossRef
19.
Winstein CJ, Rose DK, Tan SM, Lewthwaite R, Chui HC, Azen SP. A randomized controlled comparison of upper-extremity rehabilitation strategies in acute stroke: a pilot study of immediate and long-term outcomes 1 1No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit upon the author(s) or upon any organization with which the author(s) is/are associated. Arch Phys Med Rehabil. 2004;85:620–8.CrossRef
20.
Kwakkel G, Kollen BJ, Wagenaar RC. Long term effects of intensity of upper and lower limb training after stroke: a randomised trial. J Neurol Neurosurg Psychiatry. 2002;72:473–9.PubMedPubMedCentral
21.
Kwakkel G, Wagenaar RC, Twisk JW, Lankhorst GJ, Koetsier JC. Intensity of leg and arm training after primary middle-cerebral-artery stroke: a randomised trial. Lancet. 1999;354:191–6.CrossRef
22.
Wade DT, Wood VA, Hewer RL. Recovery after stroke--the first 3 months. J Neurol Neurosurg Psychiatry. 1985;48:7–13.CrossRef
23.
Kernan WN, Ovbiagele B, Black HR, Bravata DM, Chimowitz MI, Ezekowitz MD, et al. Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014;45:2160–236.CrossRef
24.
van Peppen RP, Hendriks HJ, van Meeteren NL, Helders PJ, Kwakkel G. The development of a clinical practice stroke guideline for physiotherapists in The Netherlands: a systematic review of available evidence. Disabil Rehabil. 2007;29:767–83.CrossRef
25.
Van Peppen RP, Kwakkel G, Wood-Dauphinee S, Hendriks HJ, Van der Wees PJ, Dekker J. The impact of physical therapy on functional outcomes after stroke: what’s the evidence? Clin Rehabil. 2004;18:833–62.CrossRef
26.
Investigators WMP. The World Health Organization MONICA Project (monitoring trends and determinants in cardiovascular disease): a major international collaboration. J Clin Epidemiol. 1988;41:105–14.CrossRef
27.
Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158:200–7.CrossRef
28.
Sunderland A, Tinson D, Bradley L, Hewer RL. Arm function after stroke. An evaluation of grip strength as a measure of recovery and a prognostic indicator. J Neurol Neurosurg Psychiatry. 1989;52:1267–72.CrossRef
29.
Naghdi S, Ansari NN, Mansouri K, Asgari A, Olyaei GR, Kazemnejad A. Neurophysiological examination of the Modified Modified Ashworth Scale (MMAS) in patients with wrist flexor spasticity after stroke. Electromyogr Clin Neurophysiol. 2008;48:35–41.PubMed
30.
Safaz I, Yilmaz B, Yasar E, Alaca R. Brunnstrom recovery stage and motricity index for the evaluation of upper extremity in stroke: analysis for correlation and responsiveness. Int J Rehabil Res. 2009;32:228–31.CrossRef
31.
Lin JH, Hsu MJ, Sheu CF, Wu TS, Lin RT, Chen CH, et al. Psychometric comparisons of 4 measures for assessing upper-extremity function in people with stroke. Phys Ther. 2009;89:840–50.CrossRef
32.
Alt Murphy M, Resteghini C, Feys P, Lamers I. An overview of systematic reviews on upper extremity outcome measures after stroke. BMC Neurol. 2015;15:29.CrossRef
33.
Bovend’Eerdt TJ, Botell RE, Wade DT. Writing SMART rehabilitation goals and achieving goal attainment scaling: a practical guide. Clin Rehabil. 2009;23:352–61.CrossRef
34.
Eston R, Evans HJ. The validity of submaximal ratings of perceived exertion to predict one repetition maximum. J Sports Sci Med. 2009;8:567–73.PubMedPubMedCentral
35.
Tiggemann CL, Korzenowski AL, Brentano MA, Tartaruga MP, Alberton CL, Kruel LF. Perceived exertion in different strength exercise loads in sedentary, active, and trained adults. J Strength Cond Res. 2010;24:2032–41.CrossRef
36.
MacKay-Lyons MJ, Makrides L. Cardiovascular stress during a contemporary stroke rehabilitation program:is the intensity adequate to induce a training effect? Arch Phys Med Rehabil. 2002;83:1378–83.
37.
Trinh T, Scheuer SE, Thompson-Butel AG, Shiner CT, McNulty PA. Cardiovascular fitness is improved poststroke with upper-limb Wii-based Movement Therapy but not dose-matched constraint therapy. Top Stroke Rehabil. 2016;23:1–9.CrossRef
38.
Fox SM, Naughton JP, Haskell WL. Physical activity and the prevention of coronary heart disease. Ann Clin Res. 1971;3:404–32.PubMed
39.
Türkbey TA, Kutlay S, Gök H. Clinical feasibility of Xbox KinectTM training for stroke rehabilitation: A single-blind randomized controlled pilot study. J Rehabil Med. 2017;49:22–9.CrossRef
40.
Demers M, Kong DCC, Levin MF. Feasibility of incorporating functionally relevant virtual rehabilitation in sub-acute stroke care: perception of patients and clinicians. Disabil Rehabil Assist Technol. 2018;11:1–7.CrossRef
41.
Lazzarini BSR, Dropp MW, Lloyd W. Upper-extremity explosive resistance training with older adults can be regulated using the rating of perceived exertion. J Strength Cond Res. 2017;31:831–6.CrossRef
42.
Bourbonnais D, Bilodeau S, Lepage Y, Beaudoin N, Gravel D, Forget R. Effect of force-feedback treatments in patients with chronic motor deficits after a stroke. Am J Phys Med Rehabil. 2002;81:890–7.CrossRef
43.
Armitage P, Colton T. Encyclopedia of biostatistics. Chichester: Wiley; 1998.
44.
Lang CE, Edwards DF, Birkenmeier RL, Dromerick AW. Estimating minimal clinically important differences of upper-extremity measures early after stroke. Arch Phys Med Rehabil. 2008;89:1693–700.CrossRef
45.
Högg S. Armkrafttraining in der Therapie nach Schlaganfall. Physiotherapie. 2018;36:14–8.
46.
Stein J, Krebs HI, Frontera WR, Fasoli SE, Hughes R, Hogan N. Comparison of two techniques of robot-aided upper limb exercise training after stroke. Am J Phys Med Rehabil. 2004;83:720–8.CrossRef
47.
Mancia G, De Backer G, Dominiczak A, Cifkova R, Fagard R, Germano G, et al. Guidelines for the management of arterial hypertension. J Hypertens. 2007;25:1105–87.CrossRef
48.
Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982;5:649–55.CrossRef
Metadata
Title
Upper limb strength training in subacute stroke patients: study protocol of a randomised controlled trial
Authors
Susan Högg
Manfred Holzgraefe
Insa Wingendorf
Jan Mehrholz
Christoph Herrmann
Mark Obermann
Publication date
01-12-2019
Publisher
BioMed Central
Keyword
Stroke
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3261-3

Other articles of this Issue 1/2019

Trials 1/2019 Go to the issue

Study protocol

Effects of different modalities of inspiratory muscle training as an add-on to conventional treatment of patients with chronic obstructive pulmonary disease (COPD): study protocol for a randomized controlled trial

Methodology

The OMACS-PIL study: a randomised controlled trial within the OMACS observational study

Study protocol

COSUTI: a protocol for the development of a core outcome set (COS) for interventions for the treatment of uncomplicated urinary tract infection (UTI) in adults

Study protocol

Effects of transcranial direct current stimulation on patients with disorders of consciousness after traumatic brain injury: study protocol for a randomized, double-blind controlled trial

Research

Comparison of dexmedetomidine vs. remifentanil combined with sevoflurane during radiofrequency ablation of hepatocellular carcinoma: a randomized controlled trial

Study protocol

Learning to resist the urge: a double-blind, randomized controlled trial investigating alcohol-specific inhibition training in abstinent patients with alcohol use disorder