Targeting Balance Confidence to Increase Community Integration in Users of Prostheses

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03411148
• Other study ID #: OP160044
• Secondary ID: W81XWH-17-1-0697
• Status: Completed
• Phase: N/A
• Start date: April 5, 2018
• Est. completion date: May 1, 2022

Study information

• Verified date: May 2022
• Source: Rosalind Franklin University of Medicine and Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amputation
• Physical Activity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Captain James A. Lovell Federal Health Care Center	North Chicago	Illinois
United States	Rosalind Franklin University of Medicine and Science	North Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Rosalind Franklin University of Medicine and Science	Captain James A. Lovell Federal Health Care Center, Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	Community integration	number of steps taken outside of the home	24 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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