Fear of Falling in Patients With Chronic Stroke

January 14, 2019 updated by: Shamay Ng, The Hong Kong Polytechnic University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

89

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • The Hong Kong Polytechnic University
      • Hung Hom, Hong Kong
        • The Hong Kong Polytechnic University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: GHE + TOBT training
Subjects will receive general health education and task-oriented balance training.
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.
Active Comparator: CBT + TOBT training
Subjects will receive group-based cognitive behavioral therapy and task-oriented balance training.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years
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.
2 years
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.
2 years
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.
2 years
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.
2 years
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

May 31, 2018

Study Completion (Actual)

September 30, 2018

Study Registration Dates

First Submitted

October 17, 2016

First Submitted That Met QC Criteria

October 17, 2016

First Posted (Estimate)

October 18, 2016

Study Record Updates

Last Update Posted (Actual)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 14, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SM_Ng

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on GHE + TOBT training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe