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Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

Effectiveness of a combination of cognitive behavioral therapy and task-oriented balance training in reducing the fear of falling in patients with chronic stroke: study protocol for a randomized controlled trial

Authors: Tai-Wa Liu, Gabriel Y. F. Ng, Shamay S. M. Ng

Published in: Trials | Issue 1/2018

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Abstract

Background

The consequences of falls are devastating for patients with stroke. Balance problems and fear of falling are two major challenges, and recent systematic reviews have revealed that habitual physical exercise training alone cannot reduce the occurrence of falls in stroke survivors. However, recent trials with community-dwelling healthy older adults yielded the promising result that interventions with a cognitive behavioral therapy (CBT) component can simultaneously promote balance and reduce the fear of falling. Therefore, the aim of the proposed clinical trial is to evaluate the effectiveness of a combination of CBT and task-oriented balance training (TOBT) in promoting subjective balance confidence, and thereby reducing fear-avoidance behavior, improving balance ability, reducing fall risk, and promoting independent living, community reintegration, and health-related quality of life of patients with stroke.

Methods

The study will constitute a placebo-controlled single-blind parallel-group randomized controlled trial in which patients are assessed immediately, at 3 months, and at 12 months. The selected participants will be randomly allocated into one of two parallel groups (the experimental group and the control group) with a 1:1 ratio. Both groups will receive 45 min of TOBT twice per week for 8 weeks. In addition, the experimental group will receive a 45-min CBT-based group intervention, and the control group will receive 45 min of general health education (GHE) twice per week for 8 weeks. The primary outcome measure is subjective balance confidence. The secondary outcome measures are fear-avoidance behavior, balance ability, fall risk, level of activities of daily living, community reintegration, and health-related quality of life.

Discussion

The proposed clinical trial will compare the effectiveness of CBT combined with TOBT and GHE combined with TOBT in promoting subjective balance confidence among chronic stroke patients.
We hope our results will provide evidence of a safe, cost-effective, and readily transferrable therapeutic approach to clinical practice that reduces fear-avoidance behavior, improves balance ability, reduces fall risk, promotes independence and community reintegration, and enhances health-related quality of life.

Trial registration

ClinicalTrials.gov, NCT02937532. Registered on 17 October 2016.
Literature
1.
Friedman SM, Munoz B, West SK, Rubin GS, Fried L. Falls and fear of falling: which come first? A longitudinal prediction model suggests strategies for primary and secondary prevention. J Am Geriatr Soc. 2002;50:1329–35.CrossRefPubMed
2.
Lachman ME, Howland J, Tennstedt S, Jette A, Assman S, Peterson WE. Fear of falling and activity restriction: The Survey of Activities and Fear of Falling in the Elderly (SAFE). J Gerontol B Psychol Sci Soc Sci. 1998;53B(1):43–50.CrossRef
3.
Tinetti ME, Richman D, Powell L. Falls efficacy as a measure of fear of falling. J Gerontol. 1990;45:239–43.CrossRef
4.
Powell LE, Meyers AM. The activities-specific balance confidence (ABC) scale. J Gerontol A Biol Sci Med Sci. 1995;50(1):M28–34.CrossRef
5.
Schmid AA, Acuff M, Doster K, Gwaltney-Duiser A, Whitaker A, Damush T, et al. Poststroke fear of falling in the hospital setting. Top Stroke Rehabil. 2009;16(5):357–66.
6.
Schmid AA, Van Puymbroeck M, Knies K, Spangler-Morris C, Watts K, Damush T, et al. Fear of falling among people who have sustained a stroke: a 6-month longitudinal pilot study. OTJR. 2011;65:125–32.
7.
Liu TW, Ng SSM, Kwong PWH, Ng GYF. Performance of muscles, functional mobility, and postural stability in stroke survivors with impaired subjective balance confidence. Asian J Gerontol Geriatr. 2015;10(1):54.
8.
Pang MYC, Eng JJ. Fall-related self-efficacy, not balance and mobility performance, is related to accidental falls in chronic stroke survivors with low bone mineral density. Osteoporos Int. 2008;19(7):919–27.CrossRefPubMed
9.
Pang MYC, Eng JJ, Miller WC. Determinants of satisfaction with community reintegration in older adults with chronic stroke: role of balance self-efficacy. Phys Ther. 2007;87(3):282–91.CrossRefPubMed
10.
Bula CJ, Monod S, Hoskovec C, Rochat S. Interventions aiming at balance confidence improvement in older adults: an updated review. Gerontology. 2011;57:276–86.CrossRefPubMed
11.
Sattin RW, Easley KA, Wolf SL, Chen Y, Kutner MH. Reduction in fear of falling through intense tai chi exercise training in older, transitionally frail adults. J Am Geriatr Soc. 2005;53:1168–78.CrossRefPubMed
12.
Liu HH, Rainey J, Zabel R, Quiben MU, Kehayov A, Boswell JK. Comparison of two exercise programs using the Falls Efficacy Scale, Berg Balance Scale and ankle dorsiflexor strength in older adults. Phys Occup Ther Geriatr. 2007;26:23–42.CrossRef
13.
Tennstedt S, Howland J, Lachman M, Peterson E, Kasten L, Jette A. A randomized, controlled trial of a group intervention to reduce fear of falling and associated activity restriction in older adults. J Gerontol B Psychol Sci Soc Sci. 1998;53:384–92.CrossRef
14.
Zijlstra GAR, Van Haastregt JCM, Ambergen T, Van Rossum E, Van Ejik JTM, Tennstedt SL, et al. Effects of a multicomponent cognitive behavioral group intervention on fear of falling and activity avoidance in community-dwelling older adults: results of a randomized controlled trial. J Am Geriatr Soc. 2009;57:2020–8.CrossRefPubMed
15.
Kim BH. The effects of guided relaxation and exercise imagery on older adults with a fear of falling. Diss Abstr Int. 2009;70:3771.
16.
Tang A, Tao A, Soh M, Tam C, Tan H, Thompson J, et al. The effects of interventions on balance self-efficacy in the stroke population: a systematic review and meta-analysis. Clin Rehabil. 2015;29(12):1168–77.CrossRefPubMedPubMedCentral
17.
Lord S, McPherson KM, McNaughton HK, Rochester L, Weatherall M. How feasible is the attainment of community ambulation after stroke? A pilot and randomized controlled trial to evaluate community-based physiotherapy in subacute stroke. Clin Rehabil. 2008;22(3):215–25.CrossRefPubMed
18.
Pang MY, Eng JJ. The effects of treadmill exercise training on hip bone density and tibial bone geometry in stroke survivors: a pilot study. Neurorehabil Neural Repair. 2010;24(4):386–76.CrossRef
19.
Park HJ, Oh DW, Kim SY, Choi JD. Effectiveness of community-based ambulation training for walking function of post-stroke hemiparesis: a randomized controlled pilot trial. Clin Rehabil. 2011;25(5):451–9.CrossRefPubMed
20.
Salbach NM, Mayo NE, Robichaud-Ekstrand S, Hanley JA, Richards CL, Wood-Dauphinee S. The effect of a task-oriented walking intervention on improving balance self-efficacy poststroke: a randomized, controlled trial. J Am Geriatr Soc. 2005;53(4):576–82.CrossRefPubMed
21.
Hung JW, Chou CX, Hsieh YW, Wu WC, Wu MY, Chen PC, et al. Randomized comparison trial of balance training by using exergaming and conventional weight-shift therapy in patients with chronic stroke. Arch Phys Med Rehabil. 2014;95(9):1629–37.CrossRefPubMed
22.
Schmid AA, Van Puymbroeck M, Altenburger PA, Schalk NL, Dierks TA, Miller KK, et al. Poststroke balance improves with yoga: a pilot study. Stroke. 2012;43(9):2402–7.CrossRefPubMed
23.
Holmgren E, Gosman-Hedstrom G, Lindstrom B, Wester P. What is the benefit of high-intensive exercise program? A randomized controlled trial. Adv Physiother. 2010;12(3):115–24.CrossRef
24.
Marigold DS, Eng JJ, Dawson AS, Inglis JT, Harris JE, Gylfadottir S. Exercise leads to faster postural reflexes, improved balance and mobility, and fewer falls in older persons with chronic stroke. J Am Geriatr Soc. 2005;53(3):416–23.CrossRefPubMedPubMedCentral
25.
Dickstein R, Shefi S, Holtzman S, Levy S, Peleg S, Vatine JJ. Motor imagery group practice for gait rehabilitation in individuals with post-stroke hemiparesis: a pilot study. NeuroRehabilitation. 2014;34(2):267–76.PubMed
26.
Dickstein R, Deutsch JE, Yoeli Y, Kafri M, Falash F, Dunsky A, et al. Effects of integrated motor imagery practice on gait of individuals with chronic stroke: a half-crossover randomized study. Arch Phys Med Rehabil. 2013;94(11):2119–25.CrossRefPubMed
27.
Hwang S, Jeon HS, Yi C, Kwon O, Cho S, You S. Locomotor imagery training improves gait performance in people with chronic hemiparetic stroke: a controlled clinical trial. Clin Rehabil. 2010;24(6):514–22.CrossRefPubMed
28.
Schuster C, Butler J, Andrews B, Kischka U, Ettlin T. Comparison of embedded and added motor imagery training in patients after stroke: results of a randomized controlled pilot trial. Trials. 2012;13:11.CrossRefPubMedPubMedCentral
29.
Zusman M. Cognitive-behavioral components of musculoskeletal physiotherapy: the role of control. Phys Ther Rev. 2005;10:89–98.CrossRef
30.
Ng SSM, Hui-Chan CWY. Transcutaneous electrical nerve stimulation combined with task-related training improves lower limb functions in subjects with chronic stroke. Stroke. 2007;38:2953–9.CrossRefPubMed
31.
32.
Huang TT, Chung ML, Chen FR, Chin YF, Wang BH. Evaluation of a combined cognitive-behavioural and exercise intervention to manage fear of falling among elderly residents in nursing homes. Aging Ment Health. 2016;20(1):2–12.CrossRefPubMed
33.
34.
Mak MK, Lau AL, Law FS, Cheung CC, Wong IS. Validation of the Chinese translated Activities-Specific Balance Confidence Scale. Arch Phys Med Rehabil. 2007;88:496–503.CrossRefPubMed
35.
Chu LW, Pei CKW, Ho MH, Chan PT. Validation of the abbreviated mental test (Hong Kong version) in the elderly medical patient. Hong Kong Med J. 1995;1:207–11.
36.
Jensen CV. A computer program for randomizing patients with near-even distribution of important parameters. Comput Biomed Res. 1991;24:429–34.CrossRefPubMed
37.
Myers AM, Fletcher PC, Myers AH, Sherk W. Discriminative and evaluative properties of the Activities-Specific Balance Confidence (ABC) Scale. J Gerontol A Biol Sci Med Sci. 1998;53:M287–94.CrossRefPubMed
38.
Bayouk JF, Boucher P, Leroux A. Balance training following stroke: effects of task-oriented exercises with and without altered sensory input. Int J Rehabil Res. 2006;29:51–9.CrossRefPubMed
39.
Leroux A. Exercise training to improve motor performance in chronic stroke: exercise training to improve motor performance in chronic stroke: effects of a community-based exercise program. Int J Rehabil Res. 2005;28:17–23.CrossRefPubMed
40.
Ng SSM, Hui-Chan CWY. Does the TENS increase the effectiveness of exercise for improving walking after stroke? A randomized controlled clinical trial. Clin Rehabil. 2009;23(12):1093–103.CrossRefPubMed
41.
Bandura A. The exercise of control. New York: WH Freeman; 1997.
42.
Nemmers TM, Miller JW. Factors influencing balance in healthy community-dwelling women age 60 and older. J Geriatr Phys Ther. 2008;31(3):93–100.CrossRefPubMed
43.
Bello-Haas VD, Klassen L, Sheppard MS, Metcalfe A. Psychometric properties of activity, self-efficacy, and quality-of-life measures in individuals with Parkinson disease. Physiother Can. 2011;63(1):47–57.CrossRef
44.
Botner E, Miller WC, Eng JJ. Measurement properties of the Activities-Specific Balance Confidence Scale among individuals with stroke. Disabil Rehabil. 2005;27(4):156–63.CrossRefPubMed
45.
Salbace NM, Mayo NE, Robichaud-Ekstrand S, Hanley JA, Richards CL, Wood-Dauphinee S. Balance self-efficacy and its relevance to physical function and perceived health status after stroke. Arch Phys Med Rehabil. 2006;87:364–70.CrossRef
46.
Chou KL, Yeung FKC, Wong ECH. Fear of falling and depressive symptoms in Chinese elderly living in nursing homes: fall efficacy and activity level as mediator or moderator? Aging Ment Health. 2005;9:255–61.CrossRefPubMed
47.
Berg K. Measuring balance in the elderly: preliminary development of an instrument. Physiother Can. 1989;41:304–11.CrossRef
48.
Berg K, Wood Dauphinee S, William JI. The Balance Scale: reliability assessment with elderly residents and patients with an acute stroke. Scand J Rehabil Med. 1995;27:27–36.PubMed
49.
Lord SR, Mena HB, Tiedemann A. A physiological profile approach to falls risk assessment and prevention. Phys Ther. 2003;83:237–53.PubMed
50.
Lord SR, Ward JA, Williams P, Anstey KJ. Physiological factors associated with falls in older community-dwelling women. J Am Geriatr Soc. 1994;23:452–60.
51.
Tong AYC. The validation of the Hong Kong Chinese version of the Lawton Instrumental Activities of Daily Living Scale for the institutionalized elderly persons. OTJR. 2002;22:132–42.
52.
Liu TW, Ng SS, Ng GY. Translation and initial validation of the Chinese (Cantonese) version of community integration measure for use in patients with chronic stroke. Biomed Res Int. 2014;2014:623836.PubMedPubMedCentral
53.
McColl MA, Davies D, Carlson P, Johnston J, Minnes P. The Community Integration Measure: development and preliminary validation. Arch Phys Med Rehabil. 2011;82(4):429–34.CrossRef
54.
Lam CLK, Tse EYY, Gandek B, Fong DY. The SF-36 summary scales were valid, reliable and equivalent in a Chinese population. J Clin Epidemiol. 2005;58:815–22.CrossRefPubMed
Metadata
Title
Effectiveness of a combination of cognitive behavioral therapy and task-oriented balance training in reducing the fear of falling in patients with chronic stroke: study protocol for a randomized controlled trial
Authors
Tai-Wa Liu
Gabriel Y. F. Ng
Shamay S. M. Ng
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2549-z

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