Fear of Falling in Patients With Chronic Stroke

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: GHE + TOBT training
* Behavioral: CBT + TOBT training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: GHE + TOBT training<br>Subjects will receive general health education and task-oriented balance training. | Behavioral: GHE + TOBT training<br>* All subjects will receive 45 minutes of GHE, followed by 45 minutes of TOBT program twice a week for 8 weeks.<br>|
| Active Comparator: CBT + TOBT training<br>Subjects will receive group-based cognitive behavioral therapy and task-oriented balance training. | Behavioral: CBT + TOBT training<br>* All subjects will receive 45 minutes of CBT, followed by 45 minutes of TOBT program twice a week for 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Chinese version of the Activities-specific Balance Confidence scale (ABC-C) | The ABC-C be used to assess the level of fear of falling. The ABC-C consisted of 16 items reflecting the level of balance confidence from 0% (no confidence) to 100% (complete confidence) | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Chinese version of the Lawton Instrumental Activities of Daily Living scale (IADL-C) | The IADL-C will be used to assess the ability of participants to live independently at home and community. The IADL-C included 9 items rating on a 3-point scale ranging from 0 to 18. Higher score indicates better performance. | 2 years | 
| The Chinese version of the Community Integration Measure (CIM-C) | The CIM-C consisted of 10 items soliciting on a 5-point scale in which the higher the score indicating the higher level of community integration. | 2 years | 
| The Chinese version of the Short Form General Health Questionnaire (SF-36-C) | The SF-36-C will be used to measure the health-related quality of life. It consisted of 2 scales, the physical health summary and mental health summary, rating on a two- to six-point Likert scale ranging from 0 to 100 each subscale. The higher the score indicating the higher level of health-related quality of life. | 2 years | 
| The Chinese version of the Survey of Activities and Fear of Falling in the Elderly (SAFFE-C) | The SAFFE-C will be used to assessed the level of fear avoidance behavior. It consisted of 22 items rating on a 4-point Likert scale ranging from 0 to 66. Lower score indicates less fear avoidance behaviors. | 2 years | 
| Berg Balance Scale | The BBS to assess the clinical balance. It consisted of 14 items with scoring from 0 to 56. The higher the score indicates the better balance performance. | 2 years | 
| The Short-form Physiological Profile Assessment (S-PPA) | The S-PPA will be used to assess the fall risk ranging from -2 to 4. The higher the score represents the lower the fall risk. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fear of falling, Fear avoidance behavior, cognitive behavioral therapy, Rehabilitation