N/A N=38 Randomized Single-blind Treatment

Collaborative-care Rehabilitation After Dysvascular Amputation

Diabetes Complications · Peripheral Arterial Disease

Bottom Line

View on ClinicalTrials.gov: NCT01929018 ↗

Enrolled (actual)

Serious AEs

34.2%

Results posted

Aug 2019

Primary outcome: Primary: Timed Up-and-Go Test — 19.4; 20.7; 18.2; 18.8 seconds — p=0.87

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Exercise (Behavioral); Walking Program (Behavioral); Health Self-Management Support (Behavioral)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: University of Colorado, Denver
Primary completion: Mar 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Timed Up-and-Go Test	19.4; 20.7; 18.2; 18.8; 16.7; 21.3	0.87
SECONDARY Two-Minute Walk Test	86.9; 84.4; 88.5; 83.3; 99.8; 84.0	0.75
SECONDARY Five Meter Walk Test	0.78; 0.76; 0.96; 0.83; 0.97; 0.86	0.11
SECONDARY Prosthesis Evaluation Questionnaire - Mobility Section	2.2; 2.1; 2.6; 2.0; 2.7; 2.4	0.27
SECONDARY Houghton Scale	0.64; 0.62; 0.69; 0.69; 0.77; 0.65	0.83
SECONDARY Patient-Specific Function Scale	3.3; 3.5; 5.7; 5.1; 6.9; 5.3	0.03 sig
SECONDARY Physical Activity Step Counts	1305; 1369; 2439; 1512; 2294; 1510	0.03 sig
SECONDARY Self-Efficacy in Managing Chronic Disease Questionnaire	7.6; 7.5; 7.8; 7.9; 8.1; 7.5	0.62
SECONDARY World Health Organization Disability Assessment Scale	26.2; 27.5; 24.2; 25.3; 21.6; 25.3	0.96

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01929018). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.