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Fear of Falling in Patients With Chronic Stroke

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ClinicalTrials.gov Identifier: NCT02937532
Recruitment Status : Recruiting
First Posted : October 18, 2016
Last Update Posted : November 21, 2017
Sponsor:
Information provided by (Responsible Party):
Shamay Ng, The Hong Kong Polytechnic University

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.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: GHE + TOBT training Behavioral: CBT + TOBT training Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
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
Study Start Date : February 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
Hong Kong
The Hong Kong Polytechnic University Recruiting
Hong Kong, Hong Kong
Contact: Shamay Ng, PhD    (852) 2766-4889    Shamay.Ng@inet.polyu.edu.hk   
The Hong Kong Polytechnic University Recruiting
Hung Hom, Hong Kong
Contact: Shamay Ng, PhD    2766 4889    Shamay.Ng@inet.polyu.edu.hk   
Sponsors and Collaborators
The Hong Kong Polytechnic University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shamay Ng, Associate Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT02937532     History of Changes
Other Study ID Numbers: SM_Ng
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Shamay Ng, The Hong Kong Polytechnic University:
Fear of falling
Fear avoidance behavior
cognitive behavioral therapy
Rehabilitation

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases