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Targeting Balance Confidence to Increase Community Integration in Users of Prostheses

31. maj 2022 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

22

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Illinois
      • North Chicago, Illinois, Forenede Stater, 60064
        • Captain James A. Lovell Federal Health Care Center
      • North Chicago, Illinois, Forenede Stater, 60064
        • Rosalind Franklin University of Medicine and Science

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Exercise Group A
Weekly exercise sessions with physical therapist and psychologist
Adfærdsmæssigt: 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 komparator: Exercise Group B
Home-based exercises
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Community integration
Tidsramme: 24 weeks
number of steps taken outside of the home
24 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Social Functioning scale from the 36-item Short Form Health Survey
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Well-being scale from the Prosthetic Evaluation Questionnaire
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Rosalind Franklin University of Medicine and Science

Samarbejdspartnere

Northwestern University
Captain James A. Lovell Federal Health Care Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

5. april 2018

Primær færdiggørelse (Faktiske)

1. maj 2022

Studieafslutning (Faktiske)

1. maj 2022

Datoer for studieregistrering

Først indsendt

10. januar 2018

Først indsendt, der opfyldte QC-kriterier

18. januar 2018

Først opslået (Faktiske)

26. januar 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juni 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. maj 2022

Sidst verificeret

1. maj 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • OP160044
  • W81XWH-17-1-0697 (Andet bevillings-/finansieringsnummer: Department of Defense)

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