Fear of Falling in Patients With Chronic Stroke
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|ClinicalTrials.gov Identifier: NCT02937532|
Recruitment Status : Completed
First Posted : October 18, 2016
Last Update Posted : January 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Behavioral: GHE + TOBT training Behavioral: CBT + TOBT training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||89 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|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|
|Actual Study Start Date :||October 2016|
|Actual Primary Completion Date :||May 31, 2018|
|Actual Study Completion Date :||September 30, 2018|
Placebo Comparator: GHE + TOBT training
Subjects will receive general health education and task-oriented balance training.
Behavioral: GHE + TOBT training
All subjects will receive 45 minutes of GHE, followed by 45 minutes of TOBT program twice a week for 8 weeks.
Active Comparator: CBT + TOBT training
Subjects will receive group-based cognitive behavioral therapy and task-oriented balance training.
Behavioral: CBT + TOBT training
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 Activities-specific Balance Confidence scale (ABC-C) [ Time Frame: 2 years ]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)
- The Chinese version of the Lawton Instrumental Activities of Daily Living scale (IADL-C) [ Time Frame: 2 years ]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.
- The Chinese version of the Community Integration Measure (CIM-C) [ Time Frame: 2 years ]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.
- The Chinese version of the Short Form General Health Questionnaire (SF-36-C) [ Time Frame: 2 years ]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.
- The Chinese version of the Survey of Activities and Fear of Falling in the Elderly (SAFFE-C) [ Time Frame: 2 years ]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.
- Berg Balance Scale [ Time Frame: 2 years ]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.
- The Short-form Physiological Profile Assessment (S-PPA) [ Time Frame: 2 years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02937532
|The Hong Kong Polytechnic University|
|Hong Kong, Hong Kong|
|The Hong Kong Polytechnic University|
|Hung Hom, Hong Kong|