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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GHE + TOBT training | Placebo Comparator | Subjects will receive general health education and task-oriented balance training. |
|
| CBT + TOBT training | Active Comparator | Subjects will receive group-based cognitive behavioral therapy and task-oriented balance training. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GHE + TOBT training | Behavioral | All subjects will receive 45 minutes of GHE, followed by 45 minutes of TOBT program twice a week for 8 weeks. |
|
| 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 |
| 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 |
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Inclusion criteria: Subjects will be included if they
Exclusion criteria: Subjects will be excluded if they
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hong Kong Polytechnic University | Hong Kong | Hong Kong | ||||
| The Hong Kong Polytechnic University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30580723 | Derived | 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. | |
| 29514677 | Derived | 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. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| CBT + TOBT training | Behavioral | All subjects will receive 45 minutes of CBT, followed by 45 minutes of TOBT program twice a week for 8 weeks. |
|
| 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 |
| Hung Hom |
| Hong Kong |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |