Targeting Balance Confidence to Increase Community Integration in Users of Prostheses

Study Overview
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Brief Summary
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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
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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.

Official Title
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Targeting Balance Confidence as a Strategy to Increase Integration and Improve Outcomes in Users of Lower-Limb Prostheses

Conditions
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Amputation, Physical Activity

Intervention / Treatment
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* Behavioral: Weekly exercise sessions with physical therapist and psychologist
* Behavioral: Home-based exercises


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Group A<br>Weekly exercise sessions with physical therapist and psychologist | Behavioral: Weekly exercise sessions with physical therapist and psychologist<br>* Eight weekly sessions integrating techniques from physical therapy and cognitive behavioral therapy. At the start of each session participants play virtual reality games that target balance and functional gait and then discuss their balance confidence and activity avoidance behaviors with a behavioural counselor. Weekly homework assignments ask participants to report on thoughts causing them to avoid activities and to slowly engage in activities that present increasing levels of fear.<br>|
| Placebo Comparator: Exercise Group B<br>Home-based exercises | Behavioral: Home-based exercises<br>* Stretching and other exercises are safely taught by physical therapist and then practiced at home following a provided schedule. Participants receive periodic calls to discuss progress.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Community integration | number of steps taken outside of the home | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social Functioning scale from the 36-item Short Form Health Survey | 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 | 24 weeks | 
| Role Limitation due to Emotional Problems scale from the Short Form Health Survey (SF36) | 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 | 24 weeks | 
| Extent of Participation scale from the Measure of Community Reintegration of Servicemembers | 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 | 24 weeks | 
| Perceived Limitation scale from the Measure of Community Reintegration of Servicemembers | The scale measures self-perceived limitations in community participation n a score of 10-70 with higher scores indicating less limitation | 24 weeks | 
| Frenchay Activity Index | 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. | 24 weeks | 
| Change from baseline in Activity-specific balance confidence scale following the intervention | The ABC scale measures balance confidence on a scale of 0-100 with higher values indicating greater confidence | 8 weeks | 
| Activity-specific balance confidence scale | 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 | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fear avoidance, cognitive behavioral therapy, physical therapy, prosthetic, fear of falling, gait