Combining physical therapy and cognitive behavioral therapy techniques to improve balance confidence and community participation in people with unilateral transtibial amputation who use lower limb prostheses: a study protocol for a randomized sham-control clinical trial.

BACKGROUND: Low balance confidence is a prevalent yet overlooked issue among people who use lower limb prostheses (LLP) that can diminish community integration and quality of life. There is a critical need to develop rehabilitation programs that specifically target balance confidence in people who use LLP. Previous research has shown that multicomponent interventions including cognitive-behavioral therapy (CBT) techniques and exercise are feasible and effective for improving balance confidence in older adults. Therefore, a cognitive behavioral-physical therapy (CBPT) intervention was developed to target balance confidence and increase community integration in people who use LLP.

METHODS/DESIGN: This randomized control trial will recruit 60 people who use LLP with low balance confidence. Participants will be randomized to the CBPT intervention condition or control condition.

DISCUSSION: The trial is designed to test the effects of the CBPT intervention on balance confidence and functional mobility in lower limb prosthesis users by examining self-reported and objective measures of community integration and quality of life. The trial will also examine the relationship between changes in balance confidence and changes in community integration following participation in CBPT intervention. Additionally, through participant feedback, researchers will identify opportunities to improve intervention efficacy.

TRIAL REGISTRATION: ClinicalTrials.gov, NCT03411148. Registration date: January 26, 2018.