NCT02937532

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable stroke

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

1.7 years

First QC Date

October 17, 2016

Last Update Submit

January 14, 2019

Conditions

Stroke

Keywords

Fear of fallingFear avoidance behaviorcognitive behavioral therapyRehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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)

    2 years

Secondary Outcomes (6)

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

    2 years

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

    2 years

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

    2 years

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

    2 years

  • Berg Balance Scale

    2 years

  • +1 more secondary outcomes

Study Arms (2)

GHE + TOBT training

PLACEBO COMPARATOR

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

Behavioral: GHE + TOBT training

CBT + TOBT training

ACTIVE COMPARATOR

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

Behavioral: CBT + TOBT training

Interventions

GHE + TOBT trainingBEHAVIORAL

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

GHE + TOBT training
CBT + TOBT trainingBEHAVIORAL

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

CBT + TOBT training

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

The Hong Kong Polytechnic University

Hung Hom, Hong Kong

Location

Related Publications (2)

  • 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.

    PMID: 30580723DERIVED

  • Liu 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.

    PMID: 29514677DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 17, 2016

First Posted

October 18, 2016

Study Start

October 1, 2016

Primary Completion

May 31, 2018

Study Completion

September 30, 2018

Last Updated

January 15, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

HK(2)