Fear of Falling in Patients With Chronic Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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GHE + TOBT training

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

Group Type PLACEBO_COMPARATOR

GHE + TOBT training

Intervention Type BEHAVIORAL

All subjects will receive 45 minutes of GHE, followed by 45 minutes of TOBT program twice a week for 8 weeks.

CBT + TOBT training

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

Group Type ACTIVE_COMPARATOR

CBT + TOBT training

Intervention Type BEHAVIORAL

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

Interventions

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GHE + TOBT training

All subjects will receive 45 minutes of GHE, followed by 45 minutes of TOBT program twice a week for 8 weeks.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

* 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.

Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No