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Completed

NCT Number: NCT02937532

Fear of Falling in Patients With Chronic Stroke

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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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University, Hong Kong

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GHE + TOBT training

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

Behavioral

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

Primary outcomes

  1. The Chinese version of the Activities-specific Balance Confidence scale (ABC-C)

    Time frame: 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 outcomes

  1. The Chinese version of the Lawton Instrumental Activities of Daily Living scale (IADL-C)

    Time frame: 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.

  2. The Chinese version of the Community Integration Measure (CIM-C)

    Time frame: 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.

  3. The Chinese version of the Short Form General Health Questionnaire (SF-36-C)

    Time frame: 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.

  4. The Chinese version of the Survey of Activities and Fear of Falling in the Elderly (SAFFE-C)

    Time frame: 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.

  5. Berg Balance Scale

    Time frame: 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.

  6. The Short-form Physiological Profile Assessment (S-PPA)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 18, 2016
Registry last updated
Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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