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

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....

Full description

Bibliographic Details
Main Authors: Tai-Wa Liu, Gabriel Y. F. Ng, Shamay S. M. Ng
Format: Article
Language:English
Published: BMC 2018-03-01
Series:Trials
Subjects:
Online Access:http://link.springer.com/article/10.1186/s13063-018-2549-z
_version_ 1811219034577829888
author Tai-Wa Liu
Gabriel Y. F. Ng
Shamay S. M. Ng
author_facet Tai-Wa Liu
Gabriel Y. F. Ng
Shamay S. M. Ng
author_sort Tai-Wa Liu
collection DOAJ
description 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.
first_indexed 2024-04-12T07:18:56Z
format Article
id doaj.art-040f8d3da41e4d52ad8135050df710cd
institution Directory Open Access Journal
issn 1745-6215
language English
last_indexed 2024-04-12T07:18:56Z
publishDate 2018-03-01
publisher BMC
record_format Article
series Trials
spelling doaj.art-040f8d3da41e4d52ad8135050df710cd2022-12-22T03:42:22ZengBMCTrials1745-62152018-03-0119111010.1186/s13063-018-2549-zEffectiveness 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 trialTai-Wa Liu0Gabriel Y. F. Ng1Shamay S. M. Ng2Department of Rehabilitation Sciences, The Hong Kong Polytechnic UniversityDepartment of Rehabilitation Sciences, The Hong Kong Polytechnic UniversityDepartment of Rehabilitation Sciences, The Hong Kong Polytechnic UniversityAbstract 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.http://link.springer.com/article/10.1186/s13063-018-2549-zStroke rehabilitationCognitive behavioral therapyFear of fallingSubjective balance confidenceBalance self-efficacyFall risk
spellingShingle Tai-Wa Liu
Gabriel Y. F. Ng
Shamay S. M. Ng
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
Trials
Stroke rehabilitation
Cognitive behavioral therapy
Fear of falling
Subjective balance confidence
Balance self-efficacy
Fall risk
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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Stroke rehabilitation
Cognitive behavioral therapy
Fear of falling
Subjective balance confidence
Balance self-efficacy
Fall risk
url http://link.springer.com/article/10.1186/s13063-018-2549-z
work_keys_str_mv AT taiwaliu effectivenessofacombinationofcognitivebehavioraltherapyandtaskorientedbalancetraininginreducingthefearoffallinginpatientswithchronicstrokestudyprotocolforarandomizedcontrolledtrial
AT gabrielyfng effectivenessofacombinationofcognitivebehavioraltherapyandtaskorientedbalancetraininginreducingthefearoffallinginpatientswithchronicstrokestudyprotocolforarandomizedcontrolledtrial
AT shamaysmng effectivenessofacombinationofcognitivebehavioraltherapyandtaskorientedbalancetraininginreducingthefearoffallinginpatientswithchronicstrokestudyprotocolforarandomizedcontrolledtrial