Collaborative-care Rehabilitation After Dysvascular Amputation

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University of Colorado, Denver
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01929018
First received: August 19, 2013
Last updated: October 7, 2013
Last verified: October 2013

August 19, 2013
October 7, 2013
September 2013
September 2016   (final data collection date for primary outcome measure)
Change from Baseline in Timed Up-and-Go Test at 12 weeks [ Time Frame: 12-weeks ] [ Designated as safety issue: No ]
Performance-based physical function test
Same as current
Complete list of historical versions of study NCT01929018 on ClinicalTrials.gov Archive Site
  • Change from Baseline in the Two-Minute Walk Test at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Performance-based physical function test
  • Change from Baseline in Five Meter Walk Test at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Performance-based physical function test
  • Prosthesis Evaluation Questionnaire - Mobility Section [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Self-report physical function questionnaire
  • Houghton Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Self-report physical function questionnaire
  • Patient-Specific Function Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Self-report physical function questionnaire
  • Change from Baseline in Physical Activity Counts at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Instrumented physical activity measure
  • Self-Efficacy in Managing Chronic Disease Questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Self-report questionnaire
  • World Health Organization Disability Assessment Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Self-report disability questionnaire
Same as current
Not Provided
Not Provided
 
Collaborative-care Rehabilitation After Dysvascular Amputation
Collaborative-care Rehabilitation to Improve Functional Outcomes After Dysvascular Amputation

The objective of this study is to examine the feasibility of using a collaborative-care, home-based rehabilitation program to improve functional outcomes for people recovering from lower limb amputation caused by vascular problems and/or diabetes complications. The primary hypothesis is that the rehabilitation program will result in greater improvements in performance-based and participant-reported measures of physical function, compared to standard of care after outpatient rehabilitation.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Diabetes Complications
  • Peripheral Arterial Disease
  • Behavioral: Exercise
    Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.
  • Behavioral: Walking Program
    A walking program will be established with the goal of participants walking at least five days per week. Duration of program is 12 weeks.
  • Behavioral: Health Self-Management Support
    Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period.
  • Experimental: Exercise, activity, and self-management
    Exercise, Walking Program, and Health Self-Management Support. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to deliver the interventions.
    Interventions:
    • Behavioral: Exercise
    • Behavioral: Walking Program
    • Behavioral: Health Self-Management Support
  • No Intervention: Home and phone visit
    No intervention will be applied. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to monitor health status.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
44
September 2016
September 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Diabetes and/or Peripheral Artery Disease
  2. Unilateral transtibial amputation < 6 months prior to screening
  3. Household ambulation (or better) using prosthesis prior to screening
  4. Participation in physical rehabilitation for prosthetic-use training
  5. Within the age range of 50 to 85 years old

Exclusion Criteria:

  1. Goal of wheelchair use as a primary form of locomotion (use prosthesis for transfers only)
  2. Ankle-level or more proximal amputation on contralateral limb
  3. Traumatic or cancer-related lower limb amputation
  4. Unstable heart condition (incl. unstable angina, uncontrolled cardiac dysrhythmia, acute myocarditis, and acute pericarditis)
  5. Uncontrolled hypertension
  6. Acute systemic infection
  7. Pregnant women
  8. Decisionally challenged volunteers
  9. Prisoners
Both
50 Years to 85 Years
No
Contact: Cory L Christiansen, PT, PhD 303 724-9101 cory.christiansen@ucdenver.edu
United States
 
NCT01929018
13-0179
No
University of Colorado, Denver
University of Colorado, Denver
Not Provided
Principal Investigator: Cory L Christiansen, PT, PhD University of Colorado, Denver
University of Colorado, Denver
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP