Effectiveness of CBT and Task-Oriented Balance Training in Reducing Fear of Falling in Chronic Stroke Patients

S T U D Y P R O T O C O L Open Access
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
Tai-Wa Liu 1,2
, Gabriel Y. F. Ng 1 and Shamay S. M. Ng 1*
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.
Keywords: Stroke rehabilitation, Cognitive behavioral therapy, Fear of falling, Subjective balance confidence, Balance self-
efficacy, Fall risk
* Correspondence: [e-mail]
1
Department of Rehabilitation Sciences, The Hong Kong Polytechnic
University, Hung Hom, Hong Kong, Special Administrative Region of China
Full list of author information is available at the end of the article
© The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Liu et al. Trials (2018) 19:168
https://doi.org/10.1186/s13063-018-2549-z

Background
Fear of falling (FoF) is one of the most common post-
stroke complications, and is widely acknowledged as part
of a vicious circle [1] leading to actual falls [2]. It is a de-
bilitating post-fall syndrome stemming from low balance
self-efficacy and the fearful anticipation of falling [3, 4].
The reported prevalence of FoF varies between post-
stroke stages, ranging from 54% before discharge [5] from
an acute unit to 44% at 6 months after stroke [6] and 58%
among community-dwelling patients with stroke [7]. If no
action is taken, FoF spirals into a loss of physical function,
dependency on others for assistance with activities of daily
living (ADL), restrictions on daily activities [4], and a
higher fall rate, [8] eventually compromising community
integration [9].
Two recent systematic reviews synthesized the findings
of interventions targeting FoF. Bula et al.’s [10] review of
46 randomized controlled trials (RCTs) with 6794
community-dwelling elderly persons revealed that the ma-
jority of the reviewed studies (n = 38) focused on fall pre-
vention and balance improvement, with FoF regarded as a
secondary outcome. In the eight studies directly address-
ing the fear of fearing, the use of physiological interven-
tions such as tai chi [11]; strengthening, balance and
walking exercises [12]; psychological interventions such as
cognitive behavioral therapy (CBT) [13, 14]; and guided
relaxation and exercise imagery [15] was reported to help
reduce FoF among community-dwelling older people.
In another systematic review, Tang et al. [16] examined
19 clinical trials addressing FoF among people with
stroke. Despite its significant influence on stroke re-
habilitation, FoF was regarded only as a secondary target
in the studies reviewed. Tang’s [16] meta-analysis of 15
clinical trials with 627 participants revealed that inten-
sive exercise-based physiological interventions, such as
gait training [17–20], exergaming [21], yoga [22], and a
combination of fitness, mobility and functional exercises
[23, 24], can reduce FoF with a medium effect size (stan-
dardized mean difference 0.44; 95% confidence interval
(0.11–0.77); p = 0.009). No improvements were noted in
the four reviewed studies using psychological interven-
tions (motor imagery) [25–28], and no retention effect
was noted in the studies with a follow-up assessment.
However, the effectiveness of CBT as a psychological
intervention in reducing the FoF of stroke patients has
not been examined.
CBT is a psychotherapeutic approach that redirects
negative cognitive, emotional, or behavioral responses to
help people develop coping mechanisms and self-
confidence [29]. For example, people with FoF originating
from impaired balance self-efficacy can use CBT to
change their self-defeating beliefs, improve their balance
self-efficacy and replace their unrealistic anticipation of
falls and magnified FoF consequences with a realistic,
positive perspective on falls, in turn reducing their fear
avoidance.
As summarized by Bula et al. [10] and Tang et al.
[16], studies have shown that physical exercise can re-
duce FoF in older people and people with stroke as
either a primary or a secondary outcome. As psycho-
logical interventions offer another possible means of
reducing FoF, we aim to examine the effectiveness of
a combination of CBT and task-oriented balance
training (TOBT) in reducing the FoF of people with
stroke. TOBT will be used in the proposed study be-
cause it targets stroke-specific impairments and has
been clinically proven to improve the balance per-
formance of people with stroke [30, 31]. The inclu-
sion of CBT in our treatment arm is based on our
hypothesis that CBT is an adjunct therapy capable of
optimizing the treatment effects of exercise in redu-
cing FoF. It is expected to tackle FoF directly through
the promotion of balance self-efficacy, and its indirect
effects will be mediated by repeated exercise and re-
duced fear-avoidance behavior, further enhancing bal-
ance performance and ADL, and thereby improving
community integration. The combined effects of CBT
and TOBT in reducing FoF are expected to improve
patients’ balance, reduce their risk of falling, increase
their independence, and thereby promote their com-
munity integration. Indeed, in Huang et al.’s [32] re-
cent RCT with elderly persons, CBT with an exercise
intervention (n = 27) performed better than either
CBT alone (n = 27) or treatment as usual (n = 26) in
reducing FoF and depression and enhancing mobility
and muscle strength, with retention effects observed
up to 5 months later. Therefore, the proposed study
aims to determine whether combining CBT with
TOBT augments the latter’s positive treatment effects
on FoF, and thus fear-avoidance behavior, balance
ability, fall risk, independent living, enhancing com-
munity integration, and health-related quality of life
among community-dwelling seniors with stroke.
To develop an intervention for clinical use, a protocol is
necessary to ensure the consistency of implementation
and ease of replication. Therefore, the objective of this
paper is to report the details of a protocol for combining
CBT and TOBT to reduce FoF among people with stroke.
Methods
Trial design
The proposed study will be a placebo-controlled
single-blind parallel-group RCT with a 12-month
follow-up, conducted with community-dwelling
chronic stroke survivors with FoF at a university-
based rehabilitation center. The findings of the trial
will be reported in accordance with the Consolidated
Standards of Reporting Statement [33].
Liu et al. Trials (2018) 19:168 Page 2 of 10

Choice of comparator
A placebo control intervention, general health education
(GHE), will be provided for the control group to help
measure the effects of CBT alone. To rule out potential
placebo effects such as attention from therapists and
knowledge of treatment conditions, the GHE program
will provide no information related to subjective balance
confidence, activity avoidance, falls, or physical activity,
but only information related to general health issues
such as healthy food choices and foot care.
Null hypothesis
The null hypothesis will be that the efficacy of CBT
combined with TOBT does not differ significantly from
that of GHE combined with TOBT in promoting balance
self-efficacy, thus reducing fear-avoidance behavior, en-
hancing balance ability, reducing fall risk, and improving
community reintegration and health-related quality of
life for people with stroke.
Participants
Prospective participants will be required to meet the fol-
lowing inclusion criteria: (i) aged between 55 and 85, (ii)
diagnosed with a first unilateral ischemic brain injury or in-
tracerebral hemorrhage by magnetic resonance imaging or
computed tomography within 1–6 years post-stroke, (iii)
discharged from all rehabilitation services at least 6 months
before the program, (iv) able to walk independently for at
least 10 m with or without an assistive device, (v) showing
low balance self-efficacy [scoring less than 80 on the Chin-
ese version of the Activities-specific Balance Confidence
(ABC-C) Scale] [34], (vi) scoring higher than 7 out of 10
on the Chinese version of the Abbreviated Mental Test
[35], and (vii) able to follow instructions and provide writ-
ten informed consent.
Individuals will be excluded if they have any additional
medical, cardiovascular, orthopedic, psychiatric, or psy-
chological conditions that will hinder proper treatment or
assessment, if they present with receptive dysphasia or
significant lower limb peripheral neuropathy, or if they are
involved in drug studies or other clinical trials.
Therapists and research personnel
Two research assistants with at least 2 years of research
experience in physical exercise training will be the asses-
sors of this study. They will be given a 1-day training ses-
sion on obtaining outcome measurements by an
experienced physiotherapist before the study. Training will
be provided in both the theory and practice of using the
outcome measures. All of the assessors will rehearse the
outcome measures with the research team personnel to
standardize the assessment. To establish the interrater re-
liability, the two assessors will rate five participants and
then review for discrepancies, if any.
The two TOBT therapists will have been trained by an
experienced physiotherapist and have at least 2 years of
post-qualification experience as therapists in physical ex-
ercise training. They will be provided with written pro-
gression guidelines (Table 1). A regular review of training
records and spot observations will be conducted by the
experienced physiotherapist to enhance adherence to the
written progression guidelines. The CBT therapists will be
three psychiatric nurses who have qualified as cognitive
therapists. They will all have at least 5 years of post-
qualification experience with applying CBT clinically. A
treatment manual and materials have already been devel-
oped with reference to Tennstedt et al.’s [13] and Zijlstra
et al.’s [14] research on FoF as experienced by
community-dwelling older adults and reviewed by the
three certified cognitive therapists involved in the study.
To ensure treatment integrity, the CBT intervention has
already been piloted and audiotaped. Each CBT therapist
evaluated the pilot sessions to assess their compliance
with the treatment manual, the achievement of session
goals, and the use of CBT techniques. The GHE interven-
tion will be delivered by two research assistants not in-
volved in the assessment or any other part of the
Table 1 Progression criteria for task-oriented balance training
Exercise Progression criteria Method of progression
Stepping up
and down
Able to complete 50 times Starting with a 2-in.-high wooden step, then progressing
to 4- and 6-in.-high wooden steps after the progression
criteria have been met
Heel-raising
exercises
Able to complete 25 times with at least 5 s
held on each repetition
Starting with a 2-in.-high wooden step, then progressing to
4- and 6-in.-high wooden ramp after the progression criteria
have been met
Semi-
squatting
Able to maintain knee flexion angle of 30
degrees without obvious shaking
Starting with a 3-min rest interval midway through the trial,
which is subsequently reduced to 2 min, 1 min, and 0 min
Standing on
duraDisc
Able to stand without external assistance for
at least 1 min (holding handrail or supported by another)
Decrease the base of support
Walking
across
obstacles
Able to complete the task within a pre-set
duration (20 s at the beginning) without knocking
down the obstacles
Shorten the pre-set duration and increase number
of obstacles
Liu et al. Trials (2018) 19:168 Page 3 of 10