Targeting Balance Confidence to Increase Community Integration in Users of Prostheses

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

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.

Study Overview

• Status: Completed
• Conditions: Physical Activity; Amputation
• Intervention / Treatment: Behavioral: Weekly exercise sessions with physical therapist and psychologist; Behavioral: Home-based exercises

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • North Chicago, Illinois, United States, 60064
      • Captain James A. Lovell Federal Health Care Center
    • North Chicago, Illinois, United States, 60064
      • Rosalind Franklin University of Medicine and Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise Group A; Weekly exercise sessions with physical therapist and psychologist	Behavioral: Weekly exercise sessions with physical therapist and psychologist; 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.
Placebo Comparator: Exercise Group B; Home-based exercises	Behavioral: Home-based exercises; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Well-being scale from the Prosthetic Evaluation Questionnaire	The scale measures overall quality of life on a score of 0-100 with higher scores indicating increased quality of life.	24 weeks
Change from baseline in Berg Balance Scale	This scale measures measures balance function by assessing the performance of functional tasks. It is scored from 0-45 with high scores indicating better balance.	8 wks
Change from baseline on L-test performance	Participants rise from a chair without armrests, walk 3m, turn right, walk 7m, turn around and trace their path back to the start. Time to complete the task is noted.	8 wks

Collaborators and Investigators

• Sponsor: Rosalind Franklin University of Medicine and Science
• Collaborators: Northwestern University; Captain James A. Lovell Federal Health Care Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2018
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: January 10, 2018
• First Submitted That Met QC Criteria: January 18, 2018
• First Posted (Actual): January 26, 2018

Study Record Updates

• Last Update Posted (Actual): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 31, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: gait; cognitive behavioral therapy; physical therapy; fear of falling; prosthetic; fear avoidance
• Other Study ID Numbers: OP160044; W81XWH-17-1-0697 (Other Grant/Funding Number: Department of Defense)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No