Clinical trial NCT02937532: Fear of Falling in Patients With Chronic Stroke
Official title: Effects of Combining Cognitive Behavioural Therapy With Task-oriented Balance Training for Reducing Fear of Falling in People With Chronic Stroke: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Fear of falling
Fear avoidance behavior
cognitive behavioral therapy
Rehabilitation
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2016-10-18
Enrollment: 89
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study is to evaluate whether combining cognitive-behavioral therapy (CBT) with task-oriented balance training (TOBT) is more effective than general health education (GHE) together with TOBT in promoting fear of falling and reducing activity avoidance behavior.

Detailed description: The null hypothesis of this study will be that no significant difference in the efficacy of the two treatments (CBT + TOBT; GHE + TOBT) in promoting fear of falling and reducing fear avoidance behavior, and thus no significant difference in improving balance ability, reducing fall risks, improving health-related quality of life and community reintegration of people with stroke.

Eligibility criteria: Inclusion criteria: Subjects will be included if they

* are between 55 and 85 years of age;
* have been diagnosed with a first unilateral ischemic brain injury or intracerebral hemorrhage by magnetic resonance imaging or computed tomography within the previous 1 to 6 years;
* have been discharged from all rehabilitation services at least 6 months before program begins;
* are able to work independently at least 10 meters with or without an assistive device;
* have low balance self-efficacy (The Activities-specific Balance Confidence scale score of \<80);
* are able to score \> 7 out of 10 on the Chinese version of Abbreviated Mental Test; and
* are able to follow instructions and provide written informed consent.

Exclusion criteria: Subjects will be excluded if they

* have any additional medical, cardiovascular, orthopaedic, or psychiatric or psychological condition that would hinder proper treatment or assessment;
* have receptive dysphasia;
* have significant lower peripheral neuropathy; or
* are involved in a drug studies or other clinical trial.

Primary outcomes:
measure: The Chinese version of the Activities-specific Balance Confidence scale (ABC-C)
timeFrame: 2 years
Secondary outcomes:
measure: The Chinese version of the Lawton Instrumental Activities of Daily Living scale (IADL-C)
timeFrame: 2 years
measure: The Chinese version of the Community Integration Measure (CIM-C)
timeFrame: 2 years
measure: The Chinese version of the Short Form General Health Questionnaire (SF-36-C)
timeFrame: 2 years
measure: The Chinese version of the Survey of Activities and Fear of Falling in the Elderly (SAFFE-C)
timeFrame: 2 years
measure: Berg Balance Scale
timeFrame: 2 years
measure: The Short-form Physiological Profile Assessment (S-PPA)
timeFrame: 2 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
city: Hung Hom
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
References:
citation: Liu TW, Ng GYF, Chung RCK, Ng SSM. Decreasing Fear of Falling in Chronic Stroke Survivors Through Cognitive Behavior Therapy and Task-Oriented Training. Stroke. 2019 Jan;50(1):148-154. doi: 10.1161/STROKEAHA.118.022406. Epub 2018 Dec 7.
citation: Liu TW, Ng GYF, Ng SSM. 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. 2018 Mar 7;19(1):168. doi: 10.1186/s13063-018-2549-z.