Collaborative-care Rehabilitation After Dysvascular Amputation

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-09

Study Completion Date

2017-06-29

Brief Summary

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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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Detailed Description

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Conditions

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Diabetes Complications Peripheral Arterial Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

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

Walking Program

Intervention Type 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

Intervention Type BEHAVIORAL

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise

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

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No