Clinical trial NCT01929018: Collaborative-care Rehabilitation After Dysvascular Amputation
Official title: Collaborative-care Rehabilitation to Improve Functional Outcomes After Dysvascular Amputation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Complications
Peripheral Arterial Disease
Keywords: Amputation
Rehabilitation
Exercise
Movement
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2013-08-27
Enrollment: 38
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Timed Up-and-Go Test
timeFrame: Baseline, 12-weeks, and 24 weeks
Secondary outcomes:
measure: Two-Minute Walk Test
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Five Meter Walk Test
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Prosthesis Evaluation Questionnaire - Mobility Section
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Houghton Scale
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Patient-Specific Function Scale
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Physical Activity Step Counts
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Self-Efficacy in Managing Chronic Disease Questionnaire
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: World Health Organization Disability Assessment Scale
timeFrame: Baseline, 12 weeks, and 24 weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Cory L Christiansen, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Christiansen CL, Miller MJ, Murray AM, Stephenson RO, Stevens-Lapsley JE, Hiatt WR, Schenkman ML. Behavior-Change Intervention Targeting Physical Function, Walking, and Disability After Dysvascular Amputation: A Randomized Controlled Pilot Trial. Arch Phys Med Rehabil. 2018 Nov;99(11):2160-2167. doi: 10.1016/j.apmr.2018.04.011. Epub 2018 May 7.