StrokeNCT02937532
Fear of Falling in Patients With Chronic Stroke
A study testing GHE + TOBT training and CBT + TOBT training in people with Stroke, run by The Hong Kong Polytechnic University at 2 sites in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- GHE + TOBT training and CBT + TOBT training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 2 sitesHong Kong
- Study dates
- Oct 2016to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Hong Kong2 sites
The Hong Kong Polytechnic University
Hong Kong
The Hong Kong Polytechnic University
Hung Hom
About this study
Official 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
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- GHE + TOBT training, CBT + TOBT training
- Keywords
- Fear of falling, Fear avoidance behavior, cognitive behavioral therapy, Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GHE + TOBT trainingBehavioural
All subjects will receive 45 minutes of GHE, followed by 45 minutes of TOBT program twice a week for 8 weeks.
CBT + TOBT trainingBehavioural
All subjects will receive 45 minutes of CBT, followed by 45 minutes of TOBT program twice a week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| GHE + TOBT training | Placebo comparator | Subjects will receive general health education and task-oriented balance training. Receives: Behavioral: GHE + TOBT training |
| CBT + TOBT training | Active comparator | Subjects will receive group-based cognitive behavioral therapy and task-oriented balance training. Receives: Behavioral: CBT + TOBT training |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Chinese version of the Activities-specific Balance Confidence scale (ABC-C)
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)
Measured: 2 years
Secondary outcomes (6)
The Chinese version of the Lawton Instrumental Activities of Daily Living scale (IADL-C)
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.
Measured: 2 years
The Chinese version of the Community Integration Measure (CIM-C)
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.
Measured: 2 years
The Chinese version of the Short Form General Health Questionnaire (SF-36-C)
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.
Measured: 2 years
The Chinese version of the Survey of Activities and Fear of Falling in the Elderly (SAFFE-C)
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.
Measured: 2 years
Berg Balance Scale
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.
Measured: 2 years
The Short-form Physiological Profile Assessment (S-PPA)
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startOct 2016
- Primary completion31 May 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shamay Ng, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02937532
- Sponsor's protocol ID
- SM_Ng
- Status last verified
- Jan 2019
- First submitted
- 17 Oct 2016
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Liu TW, Ng GYF, Chung RCK, Ng SSM. Decreasing Fear of Falling in Chronic Stroke Survivors Through Cognitive Behavior Therapy and Task-Oriented Training. Stroke. 2019 Jan;50(1):148-154. doi: 10.1161/STROKEAHA.118.022406. Epub 2018 Dec 7.
PubMed 30580723Liu TW, Ng GYF, Ng SSM. Effectiveness of a combination of cognitive behavioral therapy and task-oriented balance training in reducing the fear of falling in patients with chronic stroke: study protocol for a randomized controlled trial. Trials. 2018 Mar 7;19(1):168. doi: 10.1186/s13063-018-2549-z.
PubMed 29514677
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02937532
- Acronym / sponsor ID
- SM_Ng
- Conditions
- Stroke
- Keywords
- Fear of falling, Fear avoidance behavior, cognitive behavioral therapy, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 18 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GHE + TOBT training | Placebo comparator | Behavioral: GHE + TOBT trainingSubjects will receive general health education and task-oriented balance training. |
| CBT + TOBT training | Active comparator | Behavioral: CBT + TOBT trainingSubjects will receive group-based cognitive behavioral therapy and task-oriented balance training. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GHE + TOBT trainingAll subjects will receive 45 minutes of GHE, followed by 45 minutes of TOBT program twice a week for 8 weeks. | Behavioural | GHE + TOBT training |
| CBT + TOBT trainingAll subjects will receive 45 minutes of CBT, followed by 45 minutes of TOBT program twice a week for 8 weeks. | Behavioural | CBT + TOBT training |
Primary outcome
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)
6 secondary outcomes
The Chinese version of the Lawton Instrumental Activities of Daily Living scale (IADL-C)
Time frame: 2 years
The Chinese version of the Community Integration Measure (CIM-C)
Time frame: 2 years
The Chinese version of the Short Form General Health Questionnaire (SF-36-C)
Time frame: 2 years
The Chinese version of the Survey of Activities and Fear of Falling in the Elderly (SAFFE-C)
Time frame: 2 years
Berg Balance Scale
Time frame: 2 years
The Short-form Physiological Profile Assessment (S-PPA)
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Derived from this study: PubMed 30580723Liu TW, Ng GYF, Chung RCK, Ng SSM. Decreasing Fear of Falling in Chronic Stroke Survivors Through Cognitive Behavior Therapy and Task-Oriented Training. Stroke. 2019 Jan;50(1):148-154. doi: 10.1161/STROKEAHA.118.022406. Epub 2018 Dec 7.
- Derived from this study: PubMed 29514677Liu TW, Ng GYF, Ng SSM. Effectiveness of a combination of cognitive behavioral therapy and task-oriented balance training in reducing the fear of falling in patients with chronic stroke: study protocol for a randomized controlled trial. Trials. 2018 Mar 7;19(1):168. doi: 10.1186/s13063-018-2549-z.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GHE + TOBT training and CBT + TOBT training in people with Stroke, run by The Hong Kong Polytechnic University at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Chinese version of the Activities-specific Balance Confidence scale (ABC-C) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02937532, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2019.