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Limb Loss Self-Management Program

Limb Loss Self-Management Program: Promoting Amputee Life Skills

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00164502
Enrollment
500
Registered
2005-09-14
Start date
2003-10-31
Completion date
2005-06-30
Last updated
2005-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital or Acquired Limb Deficiency

Brief summary

The goal of the project is to develop and test the efficacy of a community-based self-management intervention for reducing pain, depression, and improving self-efficacy and function in person with limb loss

Detailed description

Approximately 1.2 million Americans are living with the loss of a limb and the incidence is increasing due to increases in the prevalence of diabetes. Pain, emotional distress, reduced functional abilities are common conditions following limb loss and reduce quality of life. Self-management interventions have been found to be effective in reducing the secondary conditions associated with arthritis and diabetes. Self management uses the principles of cognitive-behavioral therapy including education, self monitoring, problem solving, and skill acquisition. The goal of the project is to develop and test the efficacy of a community based self management intervention for reducing pain, depression, and improving self efficacy and function in persons with limb loss using a randomized controlled design. 50 groups of 8-10 persons will be randomized to either a control group or a treatment group.

Interventions

BEHAVIORALCommunity-based eight session group self-management program

Sponsors

Centers for Disease Control and Prevention
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* age 18 or older congenital or acquired limb loss

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frame
self-reported pain
depressed mood
positive affect

Secondary

MeasureTime frame
increase in activities and participation
improved quality of life

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026