Fear of Falling in Patients With Chronic Stroke

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Behavioral: GHE + TOBT training; Behavioral: CBT + TOBT training

• Registration Number: NCT02937532
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-17
• Study First Submitted QC: 2016-10-17
• Study First Posted: 2016-10-18
• Primary Completion: 2018-05-31
• Study Completion: 2018-09-30
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-14
• Last Update Posted: 2019-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GHE + TOBT training	GHE + TOBT training	Subjects will receive general health education and task-oriented balance training.
CBT + TOBT training	CBT + TOBT training	Subjects will receive group-based cognitive behavioral therapy and task-oriented balance training.

Primary Outcome Measures

Name	Time	Method
The Chinese version of the Activities-specific Balance Confidence scale (ABC-C)	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

Name	Time	Method
The Chinese version of the Lawton Instrumental Activities of Daily Living scale (IADL-C)	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)	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 Survey of Activities and Fear of Falling in the Elderly (SAFFE-C)	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	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 Chinese version of the Short Form General Health Questionnaire (SF-36-C)	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 Short-form Physiological Profile Assessment (S-PPA)	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.

Trial Locations

Locations (1)

The Hong Kong Polytechnic University; 🇭🇰 Hung Hom, Hong Kong