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Completed

NCT Number: NCT01929018

Collaborative-care Rehabilitation 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.

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Key information

Conditions

Diabetes Complications Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Behavior Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Motor Activity Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Require wheelchair for mobility (use prosthesis for transfers only)
  • Ankle-level or above amputation on contralateral limb
  • Traumatic or cancer-related amputation
  • Uncontrolled heart condition
  • Acute systemic infection
  • Pregnancy
  • Decisionally challenged
  • Prisoners

Treatment and study plan

Exercise

Behavioral

Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.

Walking program

Behavioral

A walking program will be established with the goal of participants walking at least five days per week. Duration of program is 12 weeks.

Health Self-Management Support

Behavioral

Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period.

Primary outcomes

  1. Timed Up-and-Go Test

    Time frame: Baseline, 12-weeks, and 24 weeks

    Performance-based physical function test able to predict falls for people with lower limb amputation. The TUG test time is taken from rising from a chair, walking 3 meters, turning, walking back and sitting down. Continuous scale; higher time indicates lower physical function, higher likelihood of falls.

Secondary outcomes

  1. Two-Minute Walk Test

    Time frame: Baseline, 12 weeks, and 24 weeks

    Performance-based physical function test measures total number of meters walked in two minutes on a level walkway.

  2. Five Meter Walk Test

    Time frame: Baseline, 12 weeks, and 24 weeks

    Performance-based physical function test measures the time to walk 5 meters at the participant's "normal, everyday pace".

  3. Prosthesis Evaluation Questionnaire - Mobility Section

    Time frame: Baseline, 12 weeks, and 24 weeks

    Self-report physical function questionnaire measures capacity to perform a list of specific functional tasks (e.g., walking upstairs, getting in and out of a vehicle. Scores range from being unable or hardly able (0) to having no problems (4). An average score across the 12-item questionnaire was used in the analysis. Lower numbers indicate less difficulty.

  4. Houghton Scale

    Time frame: Baseline, 12 weeks, and 24 weeks

    Self-report physical function questionnaire. The outcome is the sum of scores from each item (min 0, max 12). A higher score indicates higher self-report of physical function with the prosthesis.

  5. Patient-Specific Function Scale

    Time frame: Baseline, 12 weeks, and 24 weeks

    Self-report physical function questionnaire. The outcome is the average score for up to five participant-identified activities on a scale from 0-10 (min 0, max 10). Higher score indicates greater ability to perform functional activities.

  6. Physical Activity Step Counts

    Time frame: Baseline, 12 weeks, and 24 weeks

    Instrumented physical activity measure, average step counts per day

  7. Self-Efficacy in Managing Chronic Disease Questionnaire

    Time frame: Baseline, 12 weeks, and 24 weeks

    Scale range is 1-10. The score for the scale is the mean of the six items, using a ten point scale. Higher number indicates higher self-efficacy.

  8. World Health Organization Disability Assessment Scale

    Time frame: Baseline, 12 weeks, and 24 weeks

    Scores ranging from 1 (no difficulty) to 5 (extreme difficulty/cannot do). Overall disability was calculated by summing the scores for the 12 items; higher scores indicated greater disability (score range: 12-60).

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

Collaborative-care Rehabilitation to Improve Functional Outcomes After Dysvascular Amputation

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Aug 27, 2013
Registry last updated
Aug 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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