Fear of Falling in Patients With Chronic Stroke

Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02937532
• Other study ID #: SM_Ng
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: September 30, 2018

Study information

• Verified date: January 2019
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: September 30, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• CBT + TOBT training
All subjects will receive 45 minutes of CBT, followed by 45 minutes of TOBT program twice a week for 8 weeks.

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic University	Hong Kong
Hong Kong	The Hong Kong Polytechnic University	Hung Hom

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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