Fear of Falling in Patients With Chronic Stroke

Recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • GHE + TOBT training Behavioral
    Intervention Desc: All subjects will receive 45 minutes of GHE, followed by 45 minutes of TOBT program twice a week for 8 weeks.
    ARM 1: Kind: Experimental
    Label: GHE + TOBT training
    Description: Subjects will receive general health education and task-oriented balance training.
  • CBT + TOBT training Behavioral
    Intervention Desc: All subjects will receive 45 minutes of CBT, followed by 45 minutes of TOBT program twice a week for 8 weeks.
    ARM 1: Kind: Experimental
    Label: CBT + TOBT training
    Description: Subjects will receive group-based cognitive behavioral therapy and task-oriented balance training.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Supportive Care
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Fear of falling 2 years No
Secondary Fear avoidance behavior 2 years No
Secondary Balance ability 2 years No
Secondary Fall risk 2 years No
Secondary ADL 2 years No
Secondary Community reintegration 2 years No
Secondary Health-related quality of life 2 years No
Primary The Chinese version of the Activities-specific Balance Confidence scale (ABC-C) 2 years
Secondary The Chinese version of the Lawton Instrumental Activities of Daily Living scale (IADL-C) 2 years
Secondary The Chinese version of the Community Integration Measure (CIM-C) 2 years
Secondary The Chinese version of the Short Form General Health Questionnaire (SF-36-C) 2 years
Secondary The Chinese version of the Survey of Activities and Fear of Falling in the Elderly (SAFFE-C) 2 years
Secondary Berg Balance Scale 2 years
Secondary The Short-form Physiological Profile Assessment (S-PPA) 2 years

Sponsors