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Completed

NCT Number: NCT03411148

Targeting Balance Confidence to Increase Community Integration in Users of 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.

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Key information

Conditions

Amputation Behavior Motor Activity Physical Activity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Captain James A. Lovell Federal Health Care Center, North Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Weekly exercise sessions with physical therapist and psychologist

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Community integration

    Time frame: 24 weeks

    number of steps taken outside of the home

Secondary outcomes

  1. Social Functioning scale from the 36-item Short Form Health Survey

    Time frame: 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

  2. Role Limitation due to Emotional Problems scale from the Short Form Health Survey (SF36)

    Time frame: 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

  3. Extent of Participation scale from the Measure of Community Reintegration of Servicemembers

    Time frame: 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

  4. Perceived Limitation scale from the Measure of Community Reintegration of Servicemembers

    Time frame: 24 weeks

    The scale measures self-perceived limitations in community participation n a score of 10-70 with higher scores indicating less limitation

  5. Frenchay Activity Index

    Time frame: 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.

  6. Change from baseline in Activity-specific balance confidence scale following the intervention

    Time frame: 8 weeks

    The ABC scale measures balance confidence on a scale of 0-100 with higher values indicating greater confidence

  7. Activity-specific balance confidence scale

    Time frame: 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

Other outcomes

  1. Well-being scale from the Prosthetic Evaluation Questionnaire

    Time frame: 24 weeks

    The scale measures overall quality of life on a score of 0-100 with higher scores indicating increased quality of life.

  2. Change from baseline in Berg Balance Scale

    Time frame: 8 wks

    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.

  3. Change from baseline on L-test performance

    Time frame: 8 wks

    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.

Sponsors and collaborators

Lead sponsor

Rosalind Franklin University of Medicine and Science

Other

Collaborators

  • Captain James A. Lovell Federal Health Care Center
  • Northwestern University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jan 26, 2018
Registry last updated
Jun 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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