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

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 debilitating 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 majority of the reviewed studies (n = 38) focused on fall prevention and balance improvement, with FoF regarded as a secondary outcome. In the eight studies directly addressing the fear of fearing, the use of physiological interventions 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 rehabilitation, 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 intensive 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 (standardized 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 interventions (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 reduce FoF in older people and people with stroke as either a primary or a secondary outcome. As psychological 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 because it targets stroke-specific impairments and has been clinically proven to improve the balance performance of people with stroke [30, 31]. The inclusion 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 reducing 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 reduced fear-avoidance behavior, further enhancing balance 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 community integration. Indeed, in Huang et al.’s [32] recent 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 community 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.

FoF and actual falls create a vicious cycle with devastating consequences for patients with chronic stroke. In the community under study, more than half of the patients with stroke experience impaired subjective balance confidence and have suffered at least one fall since discharge. Interventions for fall prevention have focused on balance training, leaving the FoF of stroke survivors under-addressed. The aim of the proposed clinical trial is to evaluate the effectiveness of a combination of TOBT and CBT in reducing FoF, and in turn reducing fear-avoidance behavior, increasing balance, enhancing engagement in ADL, decreasing fall risk, promoting community reintegration, and enhancing the quality of life of patients with chronic stroke.

CBT is a form of clinically proven psychotherapeutic intervention designed to shape patients’ thinking and actions to achieve therapeutic goals. Research has shown that multidimensional programs with CBT components provide an effective means of treating FoF and reducing the incidence of falling among healthy older adults. This sheds light on the effects on stroke recovery of CBT combined with customary physical training. The inclusion of CBT with customary physical training will help to break the vicious cycle of FoF and actual falls and thus, enhance the rehabilitative outcomes of patients with chronic stroke.

One of the limitations of this study is not collecting data on actual falls. However, the main purpose of this study is to evaluate the augmenting effects of CBT on existing physiotherapy in enhancing subjective balance confidence. The occurrence of post-stroke falls is a complex issue involving the interplay between physical, psychological, behavioral, and environmental factors. Future studies could further examine the roles of subjective balance confidence in developing fall prevention strategies for patients with stroke. Besides, this study may involve community-dwelling stroke patients with a range of balance ability levels. Thus, the use of BBS may not be adequately sensitive to capture the balance improvement among subjects with mildly affected balance ability.

It is hoped that the results of this study will provide scientific evidence supporting the use of CBT to augment the effects of physiotherapy in enhancing subjective balance confidence and thus, stroke rehabilitation. If effective, our intervention will offer a safe, cost-effective, and readily transferrable therapeutic approach to clinical practice that reduces fear-avoidance behaviors and fall risk, improves balance and level of independence, enhances health-related quality of life, and decreases associated healthcare costs.