Fear of Falling in Patients With Chronic Stroke

The Hong Kong Polytechnic University

Status: Completed

Conditions: Stroke

Treatments: Behavioral: GHE + TOBT training; Behavioral: CBT + TOBT training

Study type: Interventional

Funder types: Other

Identifiers

NCT02937532

SM_Ng

Details and patient eligibility

About

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.

Full 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.

Enrollment: 89 patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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89 participants in 2 patient groups, including a placebo group

GHE + TOBT training

Placebo Comparator group

Description:

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

Treatment:

Behavioral: GHE + TOBT training

CBT + TOBT training

Active Comparator group

Description:

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

Treatment:

Behavioral: CBT + TOBT training