- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03411148
Targeting Balance Confidence to Increase Community Integration in Users of Prostheses
31 maj 2022 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
22
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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Illinois
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North Chicago, Illinois, Förenta staterna, 60064
- Captain James A. Lovell Federal Health Care Center
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North Chicago, Illinois, Förenta staterna, 60064
- Rosalind Franklin University of Medicine and Science
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Exercise Group A
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-jämförare: Exercise Group B
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Community integration
Tidsram: 24 weeks
|
number of steps taken outside of the home
|
24 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Social Functioning scale from the 36-item Short Form Health Survey
Tidsram: 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)
Tidsram: 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
Tidsram: 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
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24 weeks
|
Perceived Limitation scale from the Measure of Community Reintegration of Servicemembers
Tidsram: 24 weeks
|
The scale measures self-perceived limitations in community participation n a score of 10-70 with higher scores indicating less limitation
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24 weeks
|
Frenchay Activity Index
Tidsram: 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
Tidsram: 8 weeks
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The ABC scale measures balance confidence on a scale of 0-100 with higher values indicating greater confidence
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8 weeks
|
Activity-specific balance confidence scale
Tidsram: 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
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24 weeks
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Well-being scale from the Prosthetic Evaluation Questionnaire
Tidsram: 24 weeks
|
The scale measures overall quality of life on a score of 0-100 with higher scores indicating increased quality of life.
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24 weeks
|
Change from baseline in Berg Balance Scale
Tidsram: 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.
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8 wks
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Change from baseline on L-test performance
Tidsram: 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.
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8 wks
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
5 april 2018
Primärt slutförande (Faktisk)
1 maj 2022
Avslutad studie (Faktisk)
1 maj 2022
Studieregistreringsdatum
Först inskickad
10 januari 2018
Först inskickad som uppfyllde QC-kriterierna
18 januari 2018
Första postat (Faktisk)
26 januari 2018
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
1 juni 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
31 maj 2022
Senast verifierad
1 maj 2022
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- OP160044
- W81XWH-17-1-0697 (Annat bidrag/finansieringsnummer: Department of Defense)
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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