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Collaborative-care Rehabilitation After Dysvascular Amputation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01929018
First Posted: August 27, 2013
Last Update Posted: October 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Colorado, Denver
  Purpose
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.

Condition Intervention
Diabetes Complications Peripheral Arterial Disease Behavioral: Exercise Behavioral: Walking Program Behavioral: Health Self-Management Support

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Collaborative-care Rehabilitation to Improve Functional Outcomes After Dysvascular Amputation

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Change from Baseline in Timed Up-and-Go Test at 12 weeks [ Time Frame: Baseline, 12-weeks, and 24 weeks ]
    Performance-based physical function test


Secondary Outcome Measures:
  • Change from Baseline in the Two-Minute Walk Test at 12 weeks [ Time Frame: Baseline, 12 weeks, and 24 weeks ]
    Performance-based physical function test

  • Change from Baseline in Five Meter Walk Test at 12 weeks [ Time Frame: Baseline, 12 weeks, and 24 weeks ]
    Performance-based physical function test

  • Prosthesis Evaluation Questionnaire - Mobility Section [ Time Frame: Baseline, 12 weeks, and 24 weeks ]
    Self-report physical function questionnaire

  • Houghton Scale [ Time Frame: Baseline, 12 weeks, and 24 weeks ]
    Self-report physical function questionnaire

  • Patient-Specific Function Scale [ Time Frame: Baseline, 12 weeks, and 24 weeks ]
    Self-report physical function questionnaire

  • Change from Baseline in Physical Activity Counts at 12 weeks [ Time Frame: Baseline, 12 weeks, and 24 weeks ]
    Instrumented physical activity measure

  • Self-Efficacy in Managing Chronic Disease Questionnaire [ Time Frame: Baseline, 12 weeks, and 24 weeks ]
    Self-report questionnaire

  • World Health Organization Disability Assessment Scale [ Time Frame: Baseline, 12 weeks, and 24 weeks ]
    Self-report disability questionnaire


Enrollment: 38
Actual Study Start Date: October 9, 2013
Study Completion Date: June 29, 2017
Primary Completion Date: March 27, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diabetes and/or Peripheral Artery Disease
  2. Unilateral transtibial amputation < 6 months prior to screening
  3. Household ambulation using definitive prosthesis prior to baseline testing
  4. Participation in physical rehabilitation at time of baseline testing
  5. Live within 45 minutes of a participating clinic

Exclusion Criteria:

  1. Require wheelchair for mobility (use prosthesis for transfers only)
  2. Ankle-level or above amputation on contralateral limb
  3. Traumatic or cancer-related amputation
  4. Uncontrolled heart condition
  5. Acute systemic infection
  6. Pregnancy
  7. Decisionally challenged
  8. Prisoners
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01929018


Locations
United States, Colorado
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Cory L Christiansen, PT, PhD University of Colorado, Denver
  Study Documents (Full-Text)

Documents provided by University of Colorado, Denver:
Study Protocol  [PDF] October 26, 2017
Statistical Analysis Plan  [PDF] October 26, 2017

  More Information

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01929018     History of Changes
Other Study ID Numbers: 13-0179
First Submitted: August 19, 2013
First Posted: August 27, 2013
Last Update Posted: October 31, 2017
Last Verified: October 2017

Keywords provided by University of Colorado, Denver:
Amputation
Rehabilitation
Exercise
Movement

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Diabetes Complications
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Diabetes Mellitus
Endocrine System Diseases