Prosthetic Use, Mobility and Daily Functioning

Oslo Metropolitan University60 enrolled

Overview

The goal of the project is to explore which elements of rehabilitation that influence mobility in new and experienced unilateral lower-limb amputees.

Both new and experienced unilateral lower limb amputees (LLA) describe difficulties when ambulating intentionally and independently from one place to another using prosthesis. In LLA, this decreased ability to mobilize affect daily functioning and may result in low activity-levels, impeded social participation and reduced health-related quality of life. Both primary and secondary rehabilitation of LLA have implications for functional mobility. The consensus among health professionals is that LLA should train to improve their ability to ambulate. However, knowledge from research regarding which elements that constitute effective training and how systematic exercise affects body structures, functions, activity and participation in lower limb amputees, is limited. There also is a lack of knowledge of how prosthetic users endure and process the challenges regarding mobility, how they adapt to the use of their prosthesis, how safe they are ambulating using the prosthesis, and how pain and psychosocial issues affect their perceived health and mobility. The aim of this Ph.D.-project is to explore how a period of semi-standardized individualized rehabilitation originating from an evidence-based approach, affect the functional mobility of both new and experienced LLA, and how LLA process the loss of a limb and challenges during ambulation.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lower Leg Amputations

Interventions

Rehabilitation InterventionOTHER

Strength, flexibility, endurance, balance, mobility, (self-efficacy)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria for experienced users of prosthesis - intervention group: * Unilaterally amputated (above the ankle joint / under the hip joint) * Minimum 12 months since amputation * Have a well-adapted prosthesis before baseline measurements * Not attended an organized, regular training program for the last 6 months * Uses the prosthesis on a daily basis * Participation approved by physician Inclusion Criteria for experienced users of prosthesis - control group: * Unilaterally amputated (above the ankle joint / under the hip joint) * Minimum 12 months since amputation * Have a well-adapted prosthesis before baseline measurements * Daily use of the prosthesis * Not attended an organized, regular training program in the last 6 months * No participation in regular and systematic training between pre- and post-testing Inclusion Criteria for new users of prosthesis: * Unilaterally amputated (above the ankle joint / under the hip joint) * No prior record of use of prosthesis * Participation approved by physician Exclusion Criteria: * Bilaterally amputated over ankle joint * Lack of understanding of Norwegian language (oral, written) * Neurological disorders affecting gait function * Skin lesion or abrasion on the stump or remaining extremity affecting mobility and function * Other issues that complicate participation in a rehabilitation intervention

Locations (2)

Unicare Bakke

Halden, Akershus, Norway

OsloMet

Oslo, Norway

Outcomes

Primary Outcomes

Prosthetic Limb Users Survey of Mobility (Plus-M) Short form - 12 items

A questionnaire that measures different aspects of mobility in lower-limb amputees (LLA) using prosthesis. PLUS-M provide a score range from 17.5 to 76.6. High scores indicate better outcome.

Time frame: 4-8 weeks

The Amputee Mobility Predictor (AMP).

The test is designed to measure mobility and ability to move with prosthesis (AMPPro) and without prosthesis (AMPNoPro). AMPPro provide a score range from 0-47. AMPNoPro provide a score range from 0-43. High scores indicate better outcome.

Time frame: 4-8 weeks

Data from ClinicalTrials.gov

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