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Targeting Balance Confidence to Increase Community Integration in Users of Prostheses

NCT03411148 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2022-06-01

No results posted yet for this study

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.

Conditions

  • Amputation
  • Physical Activity

Interventions

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.

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.

Sponsors & Collaborators

  • Northwestern University

    collaborator OTHER

  • Captain James A. Lovell Federal Health Care Center

    collaborator FED

  • Rosalind Franklin University of Medicine and Science

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-05
Primary Completion
2022-05-01
Completion
2022-05-01

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03411148 on ClinicalTrials.gov