Protocol for a randomized controlled clinical trial investigating the effectiveness of Fast muscle Activation and Stepping Training (FAST) for improving balance and mobility in sub-acute stroke

Kimberly J Miller, Michael A Hunt, Courtney L Pollock, Dianne Bryant, S Jayne Garland, Kimberly J Miller, Michael A Hunt, Courtney L Pollock, Dianne Bryant, S Jayne Garland

Abstract

Background: Following stroke, many people have difficulty activating their paretic muscles quickly and with sufficient power to regain their balance by taking quick and effective steps. Reduced dynamic balance and mobility following stroke, or 'walking balance', is associated with reduced self-efficacy and restrictions in daily living activities, community integration, and quality of life. Targeted training of movement speeds required to effectively regain balance has been largely overlooked in post-stroke rehabilitation. The Fast muscle Activation and Stepping Training (FAST) program incorporates fast functional movements known to produce bursts of muscle activation essential for stepping and regaining standing balance effectively. The purpose of this study is to: 1) compare the effectiveness of an outpatient FAST program to an active control outpatient physiotherapy intervention in improving walking balance following stroke, and 2) explore potential mechanisms associated with improvements in walking balance.

Methods/design: This will be an assessor-blinded, parallel group randomized controlled trial design. Sixty participants (30 per group) who have sustained a stroke within the previous six months will be randomly assigned with stratification for lower limb motor recovery to receive twelve 45-minute 1:1 physiotherapy intervention sessions over 6 - 10 weeks in an outpatient setting of either: 1) FAST intervention - systematic and progressive practice of fast squatting and stepping exercises, or 2) active control - conventional physiotherapy directed at improving balance and mobility that includes no targeted fast movement training. The same blinded research physiotherapist will assess outcomes at three time points: 1) baseline (prior to intervention), 2) follow up (within one week post-intervention); and 3) retention (one month post-intervention). The primary outcome is dynamic balance assessed using the Community Balance and Mobility Scale. We will also assess fast and self-selected walking speed, balance self-efficacy, and the ability to respond to internal and external perturbations to balance and associated changes in postural muscle activation.

Discussion: The targeted training of fast functional movements in the FAST program is expected to improve walking balance following stroke compared to the active control intervention. Unique to this study is the investigation of potential mechanisms associated with improvements in walking balance.

Trial registration: NCT01573585.

Figures

Figure 1
Figure 1
Design of the FAST Study. Flow chart illustrating study design from initial contact with potential participants to retention assessment. CMSA, Chedoke-McMaster Stroke Assessment.

References

    1. Tyson SF, Hanley M, Chillala J, Selley A, Tallis RC. Balance disability after stroke. Phys Ther. 2006;86:30–38.
    1. Pollock CL, Eng JJ, Garland SJ. Clinical measurement of walking balance in people post stroke: a systematic review. Clin Rehabil. 2011;25:693–708. doi: 10.1177/0269215510397394.
    1. Mayo NE, Wood-Dauphinee S, Côté R, Durcan L, Carlton J. Activity, participation, and quality of life 6 months poststroke. Arch Phys Med Rehabil. 2002;83:1035–1042. doi: 10.1053/apmr.2002.33984.
    1. Blennerhassett JM, Dite W, Ramage ER, Richmond ME. Changes in Balance and Walking From Stroke Rehabilitation to the Community: A Follow-Up Observational Study. Arch Phys Med Rehabil. 2012;93:1782–1787. doi: 10.1016/j.apmr.2012.04.005.
    1. Gray V, Rice CL, Garland SJ. Factors that influence muscle weakness following stroke and their clinical implications: a critical review. Physiother Can. 2012;64:415–426. doi: 10.3138/ptc.2011-03.
    1. Lum PS, Patten C, Kothari D, Yap R. Effects of velocity on maximal torque production in poststroke hemiparesis. Muscle Nerve. 2004;30:732–742. doi: 10.1002/mus.20157.
    1. Garland SJ, Gray VL, Knorr S. Muscle activation patterns and postural control following stroke. Mot Control. 2009;13:387–411.
    1. Clark DJ, Patten C, Reid KF, Carabello RJ, Phillips EM, Fielding RA. Muscle performance and physical function are associated with voluntary rate of neuromuscular activation in older adults. J Gerontol A Biol Sci Med Sci. 2011;66:115–121. doi: 10.1093/gerona/glq153.
    1. Winter DA, Patla AE, Prince F, Ishac M, Gielo-Perczak K. Stiffness control of balance in quiet standing. J Neurophysiol. 1998;80:1211–1221.
    1. Horak FB, Nashner LM. Central programming of postural movements: adaptation to altered support-surface configurations. J Neurophysiol. 1986;55:1369–1381.
    1. Garland SJ, Ivanova TD, Mochizuki G. Recovery of standing balance and health-related quality of life after mild or moderately severe stroke. Arch Phys Med Rehabil. 2007;88:218–227. doi: 10.1016/j.apmr.2006.11.023.
    1. Horak FB, Wrisley DM, Frank J. The Balance Evaluation Systems Test (BESTest) to differentiate balance deficits. Phys Ther. 2009;89:484–498. doi: 10.2522/ptj.20080071.
    1. Geurts AC, de Haart M, van Nes IJ, Duysens J. A review of standing balance recovery from stroke. Gait Posture. 2005;22:267–281. doi: 10.1016/j.gaitpost.2004.10.002.
    1. Maki BE, McIlroy WE. Control of rapid limb movements for balance recovery: age-related changes and implications for fall prevention. Age Ageing. 2006;35:ii12–ii18. doi: 10.1093/ageing/afl078.
    1. Gray VL, Ivanova TD, Garland SJ. Effects of fast functional exercise on muscle activity after stroke. Neurorehabil Neural Repair. 2012;26:968–975. doi: 10.1177/1545968312437944.
    1. Canadian Stroke Best Practices Advisory Committee and Writing Groups . Canadian Stroke Best Practice Recommendations. 4. Ottawa: Canadian Heart and Stroke Foundation; 2013. Section 5: Rehabilitation.
    1. Gray VL, Juren LM, Ivanova TD, Garland SJ. Retraining postural responses with exercises emphasizing speed poststroke. Phys Ther. 2012;92:924–934. doi: 10.2522/ptj.20110432.
    1. Pollock CL, Boyd LA, Hunt MA, Garland SJ. Use of the challenge point framework to guide motor learning of stepping reactions for improved balance control in people with stroke: a case series. Phys Ther. 2014;94:562–570. doi: 10.2522/ptj.20130046.
    1. Mackintosh SF, Hill KD, Dodd KJ, Goldie PA, Culham EG. Balance score and a history of falls in hospital predict recurrent falls in the 6 months following stroke rehabilitation. Arch Phys Med Rehabil. 2006;87:1583–1589. doi: 10.1016/j.apmr.2006.09.004.
    1. Knorr S, Brouwer B, Garland SJ. Validity of the Community Balance and Mobility Scale in Community-Dwelling Persons After Stroke. Arch Phys Med Rehabil. 2010;91:890–896. doi: 10.1016/j.apmr.2010.02.010.
    1. Howe JA, Inness EL, Venturini A, Williams JI, Verrier MC. The Community Balance and Mobility Scale-a balance measure for individuals with traumatic brain injury. Clin Rehabil. 2006;20:885–895.
    1. Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleža-Jerić K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586. doi: 10.1136/bmj.e7586.
    1. Chan AW, Tetzlaff JM, Altman DG, Dickersin K, Moher D. SPIRIT 2013: new guidance for content of clinical trial protocols. Lancet. 2013;381:91–92. doi: 10.1016/S0140-6736(12)62160-6.
    1. Gowland C, Van Hullenaar S, Moreland J, Vanspall B, Barreca S, Ward M, Huijbregts M, Stratford P, Barclay-Goddard R. Chedoke-McMaster Stroke Assessment. Development, Validation and Administration Manual. Hamilton: Chedoke-McMaster Hospitals and McMaster University; 1995.
    1. Gowland C, Stratford P, Ward M, Moreland J, Torresin W, Van Hullenaar S, Sanford J, Barreca S, Vanspall B, Plews N. Measuring physical impairment and disability with the Chedoke-McMaster Stroke Assessment. Stroke. 1993;24:58–63. doi: 10.1161/01.STR.24.1.58.
    1. Berg K, Wood-Dauphinee S, Williams JI. The Balance Scale: reliability assessment with elderly residents and patients with an acute stroke. Scand J Rehabil Med. 1995;27:27–36.
    1. Garland SJ, Stevenson TJ, Ivanova T. Postural responses to unilateral arm perturbation in young, elderly, and hemiplegic subjects. Arch Phys Med Rehabil. 1997;78:1072–1077. doi: 10.1016/S0003-9993(97)90130-1.
    1. Tombaugh TN, McIntyre NJ. The mini-mental state examination: a comprehensive review. J Am Geriatr Soc. 1992;40:922–935.
    1. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet. 2001;357:1191–1194. doi: 10.1016/S0140-6736(00)04337-3.
    1. MacKinnon CD, Bissig D, Chiusano J, Miller E, Rudnick L, Jager C, Zhang Y, Mille ML, Rogers MW. Preparation of anticipatory postural adjustments prior to stepping. J Neurophysiol. 2007;97:4368–4379. doi: 10.1152/jn.01136.2006.
    1. Guadagnoli MA, Lee TD. Challenge Point: A Framework for Conceptualizing the Effects of Various Practice Conditions in Motor Learning. J Mot Behav. 2004;36:212–224. doi: 10.3200/JMBR.36.2.212-224.
    1. Dite W, Temple VA. A clinical test of stepping and change of direction to identify multiple falling older adults. Arch Phys Med Rehabil. 2002;83:1566–1571. doi: 10.1053/apmr.2002.35469.
    1. Skof B, Strojnik V. The effect of two warm-up protocols on some biomechanical parameters of the neuromuscular system of middle distance runners. J Strength Cond Res. 2007;21:394–399. doi: 10.1519/R-18055.1.
    1. Tyson SF, Connell LA, Lennon S, Busse ME. What treatment packages do UK physiotherapists use to treat postural control and mobility problems after stroke? Disabil Rehabil. 2009;31:1494–1500. doi: 10.1080/09638280802627686.
    1. Michie S, Johnston M, Francis J, Hardeman W, Eccles M. From Theory to Intervention: Mapping Theoretically Derived Behavioural Determinants to Behaviour Change Techniques. Appl Psychol-Int Rev. 2008;57:660–680. doi: 10.1111/j.1464-0597.2008.00341.x.
    1. Lam HS, Lau FW, Chan GK, Sikes K. The validity and reliability of a 6-metre timed walk for the functional assessment of patients with stroke. Physiother Theory Pract. 2010;26:251–255. doi: 10.3109/09593980903015235.
    1. Tilson JK, Sullivan KJ, Cen SY, Rose DK, Koradia CH, Azen SP, Duncan PW. Meaningful gait speed improvement during the first 60 days poststroke: minimal clinically important difference. Phys Ther. 2010;90:196–208. doi: 10.2522/ptj.20090079.
    1. Powell LE, Myers AM. The Activities-specific Balance Confidence (ABC) Scale. J Gerontol A Biol Sci Med Sci. 1995;1:M28–34. doi: 10.1093/gerona/50A.1.M28.
    1. Beninato M, Portney LG, Sullivan PE. Using the International Classification of Functioning, Disability and Health as a framework to examine the association between falls and clinical assessment tools in people with stroke. Phys Ther. 2009;89:816–825. doi: 10.2522/ptj.20080160.
    1. Kadaba MP, Ramakrishnan HK, Wootten ME, Gainey J, Gorton G, Cochran GV. Repeatability of kinematic, kinetic, and electromyographic data in normal adult gait. J Orthop Res. 1989;7:849–860. doi: 10.1002/jor.1100070611.
    1. Hsu W-L, Krishnamoorthy V, Scholz JP. An alternative test of electromyographic normalization in patients. Muscle Nerve. 2006;33:232–241. doi: 10.1002/mus.20458.
    1. Winter DA. Biomechanics and Motor Control of Human Movement. 2. New York, NY: John Wiley & Sons Inc.; 1990.
    1. Hunt MA, Wrigley TV, Hinman RS, Bennell KL. Individuals with severe knee osteoarthritis (OA) exhibit altered proximal walking mechanics compared with individuals with less severe OA and those without knee pain. Arthritis Care Res. 2010;62:1426–1432. doi: 10.1002/acr.20248.
    1. Juras G, Słomka K, Fredyk A, Sobota G, Bacik B. Evaluation of the Limits of Stability (LOS) Balance Test. JHK. 2008;19:39–52.
    1. Wolfson LI, Whipple R, Amerman P, Kleinberg A. Stressing the postural response. A quantitative method for testing balance. J Am Geriatr Soc. 1986;34:845–850.
    1. Harburn KL, Hill KM, Kramer JF, Noh S, Vandervoort AA, Teasell R. Clinical applicability and test-retest reliability of an external perturbation test of balance in stroke subjects. Arch Phys Med Rehabil. 1995;76:317–323. doi: 10.1016/S0003-9993(95)80656-3.
    1. Pollock CL, Ivanova TD, Hunt MA, Garland SJ: Motor unit recruitment and firing rate in medial gastrocnemius muscles during external perturbations in standing in humans.J Neurophysiol 2014, [Epub ahead of print].
    1. Mochizuki G, Ivanova TD, Garland SJ. Postural muscle activity during bilateral and unilateral arm movements at different speeds. Exp Brain Res. 2004;155:352–361. doi: 10.1007/s00221-003-1732-x.
    1. Winter DA, Patla AE, Ishac M, Gage WH. Motor mechanisms of balance during quiet standing. J Electromyogr Kinesiol. 2003;13:49–56. doi: 10.1016/S1050-6411(02)00085-8.

Source: PubMed

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

3
S'abonner