Targeting Balance Confidence to Increase Community Integration in Users of Prostheses
- Conditions
- AmputationPhysical Activity
- Interventions
- Behavioral: Weekly exercise sessions with physical therapist and psychologistBehavioral: Home-based exercises
- Registration Number
- NCT03411148
- Brief Summary
Low balance confidence occurs when an individual perceives they have limited ability to maintain their balance while performing a specific task of daily living. It is a prevalent problem in lower limb prosthesis users and is a strong predictor of prosthesis use and community participation. Balance confidence is not necessarily related to functional abilities. It is possible to improve functional ability as a result of rehabilitation, without concurrently improving balance confidence. Interventions to address low balance confidence may need to target both functional abilities as well as beliefs regarding these abilities. The purpose of this study is to test whether, for users of lower limb prostheses, an intervention combining physical therapy exercise to improve function with cognitive behavioral therapy to address fears and thoughts associated with low confidence can improve balance confidence and promote community participation.
- Detailed Description
Lower limb prosthesis users, with self-reported low balance confidence complete baseline gait analysis and balance testing, as well as a series of validated self-reported outcome scales addressing balance confidence, quality of life, and community integration. Participants are then provided a step activity monitor (SAM) and a global position sensing (GPS) tracker to be worn for one week, the data from which is linked and used to objectively quantify baseline community participation. At the conclusion of the one week, participants are randomized to one of two groups, each of which will last for 8 weeks. At the conclusion of the eight weeks, participants repeat baseline assessments and are again provided a SAM and GPS tracker to wear for one week. Baseline measures and activity monitoring occur again 8 and 16 weeks thereafter.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
- age ≥18 years
- unilateral lower limb amputation without serious complications
- at least 6 months experience using a definitive lower limb prosthesis
- Activity Specific Balance Confidence (ABC) scale score≤80
- self-reported concern about balance that limit activities
- active wounds on weight bearing surfaces
- inability to perform the protocol without an assistive device
- currently seeing a physical therapist for any reason
- history of neurodegenerative disease
- history of stroke
- ill-fitting or ill-functioning prosthesis (to be verified by research prosthetist during screening)
- prohibited by primary care physician or research physician to participate in mild exercise
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exercise Group A Weekly exercise sessions with physical therapist and psychologist Weekly exercise sessions with physical therapist and psychologist Exercise Group B Home-based exercises Home-based exercises
- Primary Outcome Measures
Name Time Method Community integration 24 weeks number of steps taken outside of the home
- Secondary Outcome Measures
Name Time Method Social Functioning scale from the 36-item Short Form Health Survey 24 weeks The scale measures the extent to which physical and emotional problems interfere with social activities on a scale of 0-100 with higher scores indicating less interference
Perceived Limitation scale from the Measure of Community Reintegration of Servicemembers 24 weeks The scale measures self-perceived limitations in community participation n a score of 10-70 with higher scores indicating less limitation
Change from baseline in Activity-specific balance confidence scale following the intervention 8 weeks The ABC scale measures balance confidence on a scale of 0-100 with higher values indicating greater confidence
Role Limitation due to Emotional Problems scale from the Short Form Health Survey (SF36) 24 weeks The scale measures the extent to which emotional problems interfere with work and daily activities on a scale of 0-100 with higher scores indicating less interference
Extent of Participation scale from the Measure of Community Reintegration of Servicemembers 24 weeks The scale measures community participation in terms of how often an individual engages in certain activities on a score of 10-70 with higher scores indicating greater participation
Frenchay Activity Index 24 weeks This is a behavioral scale that primarily measures social participation, as well as daily activities on a score of 0-45 with higher scores indicating greater social activity.
Activity-specific balance confidence scale 24 weeks The ABC scale measures balance confidence on a scale of 0-100 with higher values indicating greater confidence. Measurement at this time point will indicate the lasting impact of the intervention on balance confidence
Trial Locations
- Locations (2)
Rosalind Franklin University of Medicine and Science
🇺🇸North Chicago, Illinois, United States
Captain James A. Lovell Federal Health Care Center
🇺🇸North Chicago, Illinois, United States