Targeting Balance Confidence to Increase Community Integration in Users of Prostheses

May 31, 2022 updated by: Noah Rosenblatt, Rosalind Franklin University of Medicine and Science

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Community integration
Time Frame: 24 weeks
number of steps taken outside of the home
24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
24 weeks
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
24 weeks
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
24 weeks
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
24 weeks
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.
24 weeks
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
8 weeks
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
24 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
24 weeks
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.
8 wks
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.
8 wks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rosalind Franklin University of Medicine and Science

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Northwestern University
Captain James A. Lovell Federal Health Care Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 5, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Physical Activity

Clinical Trials on Weekly exercise sessions with physical therapist and psychologist

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings