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Fear of Falling in Patients With Chronic Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
GHE + TOBT training
CBT + TOBT training
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke focused on measuring Fear of falling, Fear avoidance behavior, cognitive behavioral therapy, Rehabilitation

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Hong Kong Polytechnic University
  • The Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

GHE + TOBT training

CBT + TOBT training

Arm Description

Subjects will receive general health education and task-oriented balance training.

Subjects will receive group-based cognitive behavioral therapy and task-oriented balance training.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
October 17, 2016
Last Updated
January 14, 2019
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT02937532
Brief Title
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

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Fear of falling, Fear avoidance behavior, cognitive behavioral therapy, Rehabilitation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GHE + TOBT training
Arm Type
Placebo Comparator
Arm Description
Subjects will receive general health education and task-oriented balance training.
Arm Title
CBT + TOBT training
Arm Type
Active Comparator
Arm Description
Subjects will receive group-based cognitive behavioral therapy and task-oriented balance training.
Intervention Type
Behavioral
Intervention Name(s)
GHE + TOBT training
Intervention Description
All subjects will receive 45 minutes of GHE, followed by 45 minutes of TOBT program twice a week for 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
CBT + TOBT training
Intervention Description
All subjects will receive 45 minutes of CBT, followed by 45 minutes of TOBT program twice a week for 8 weeks.
Primary Outcome Measure Information:
Title
The Chinese version of the Activities-specific Balance Confidence scale (ABC-C)
Description
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)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
The Chinese version of the Lawton Instrumental Activities of Daily Living scale (IADL-C)
Description
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.
Time Frame
2 years
Title
The Chinese version of the Community Integration Measure (CIM-C)
Description
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.
Time Frame
2 years
Title
The Chinese version of the Short Form General Health Questionnaire (SF-36-C)
Description
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.
Time Frame
2 years
Title
The Chinese version of the Survey of Activities and Fear of Falling in the Elderly (SAFFE-C)
Description
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.
Time Frame
2 years
Title
Berg Balance Scale
Description
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.
Time Frame
2 years
Title
The Short-form Physiological Profile Assessment (S-PPA)
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hong Kong
Country
Hong Kong
Facility Name
The Hong Kong Polytechnic University
City
Hung Hom
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30580723
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.
Results Reference
derived
PubMed Identifier
29514677
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.
Results Reference
derived

Learn more about this trial

Fear of Falling in Patients With Chronic Stroke

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