NCT03411148

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 26, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

April 5, 2018

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2022

Enrollment Period

4.1 years

First QC Date

January 10, 2018

Last Update Submit

May 31, 2022

Conditions

AmputationPhysical Activity

Keywords

fear avoidancecognitive behavioral therapyphysical therapyprostheticfear of fallinggait

Outcome Measures

Primary Outcomes (1)

  • Community integration

    number of steps taken outside of the home

    24 weeks

Secondary Outcomes (7)

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

    24 weeks

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

    24 weeks

  • Extent of Participation scale from the Measure of Community Reintegration of Servicemembers

    24 weeks

  • Perceived Limitation scale from the Measure of Community Reintegration of Servicemembers

    24 weeks

  • Frenchay Activity Index

    24 weeks

  • +2 more secondary outcomes

Other Outcomes (3)

  • Well-being scale from the Prosthetic Evaluation Questionnaire

    24 weeks

  • Change from baseline in Berg Balance Scale

    8 wks

  • Change from baseline on L-test performance

    8 wks

Study Arms (2)

Exercise Group A

EXPERIMENTAL

Weekly exercise sessions with physical therapist and psychologist

Behavioral: Weekly exercise sessions with physical therapist and psychologist

Exercise Group B

PLACEBO COMPARATOR

Home-based exercises

Behavioral: Home-based exercises

Interventions

Weekly exercise sessions with physical therapist and psychologistBEHAVIORAL

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.

Exercise Group A
Home-based exercisesBEHAVIORAL

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.

Exercise Group B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Captain James A. Lovell Federal Health Care Center

North Chicago, Illinois, 60064, United States

Location

Rosalind Franklin University of Medicine and Science

North Chicago, Illinois, 60064, United States

Location

Related Publications (3)

  • Rosenblatt NJ, Schneider KL, Miller SA, Hagopian K, Hagg S, Reddin C, Churchill R, Dams GM, Calamari JE, Stachowiak A, Major MJ. Mixed methods analysis of an interdisciplinary intervention to promote balance confidence in lower limb prosthesis users. Front Rehabil Sci. 2025 Sep 1;6:1626051. doi: 10.3389/fresc.2025.1626051. eCollection 2025.

    PMID: 40959746DERIVED

  • B Aledi L, Flumignan CD, Trevisani VF, Miranda F Jr. Interventions for motor rehabilitation in people with transtibial amputation due to peripheral arterial disease or diabetes. Cochrane Database Syst Rev. 2023 Jun 5;6(6):CD013711. doi: 10.1002/14651858.CD013711.pub2.

    PMID: 37276273DERIVED

  • 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.

    PMID: 31888708DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Physical Therapists

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 10, 2018

First Posted

January 26, 2018

Study Start

April 5, 2018

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

June 1, 2022

Record last verified: 2022-05

Locations

US(2)