Clinical trial NCT03411148: Targeting Balance Confidence to Increase Community Integration in Users of Prostheses
Official title: Targeting Balance Confidence as a Strategy to Increase Integration and Improve Outcomes in Users of Lower-Limb Prostheses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation
Physical Activity
Keywords: fear avoidance
cognitive behavioral therapy
physical therapy
prosthetic
fear of falling
gait
Lead sponsor: Rosalind Franklin University of Medicine and Science
Sponsor class: OTHER
Collaborators: name: Northwestern University
name: Captain James A. Lovell Federal Health Care Center
First posted: 2018-01-26
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Community integration
timeFrame: 24 weeks
Secondary outcomes:
measure: Social Functioning scale from the 36-item Short Form Health Survey
timeFrame: 24 weeks
measure: Role Limitation due to Emotional Problems scale from the Short Form Health Survey (SF36)
timeFrame: 24 weeks
measure: Extent of Participation scale from the Measure of Community Reintegration of Servicemembers
timeFrame: 24 weeks
measure: Perceived Limitation scale from the Measure of Community Reintegration of Servicemembers
timeFrame: 24 weeks
measure: Frenchay Activity Index
timeFrame: 24 weeks
measure: Change from baseline in Activity-specific balance confidence scale following the intervention
timeFrame: 8 weeks
measure: Activity-specific balance confidence scale
timeFrame: 24 weeks
Other outcomes:
measure: Well-being scale from the Prosthetic Evaluation Questionnaire
timeFrame: 24 weeks
measure: Change from baseline in Berg Balance Scale
timeFrame: 8 wks
measure: Change from baseline on L-test performance
timeFrame: 8 wks
Locations:
city: North Chicago
country: United States
facility: Captain James A. Lovell Federal Health Care Center
state: Illinois
city: North Chicago
country: United States
facility: Rosalind Franklin University of Medicine and Science
state: Illinois
Study officials:
References:
citation: Bourque MO, Schneider KL, Calamari JE, Reddin C, Stachowiak A, Major MJ, Duncan C, Muthukrishnan R, Rosenblatt NJ. 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. Trials. 2019 Dec 30;20(1):812. doi: 10.1186/s13063-019-3929-8.