Prosthetic Use, Mobility and Daily Functioning

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

Detailed Description
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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.

Official Title
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Prosthetic Use, Mobility and Daily Functioning

Conditions
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Lower Leg Amputations

Intervention / Treatment
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* Other: Rehabilitation Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One explorative group, one intervention group and one control group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experienced LLA - intervention<br>Experienced lower-limb amputees that complete a 4-week semi-structured individualized rehabilitation regime with extensive testing before and after the intervention. | Other: Rehabilitation Intervention<br>* Strength, flexibility, endurance, balance, mobility, (self-efficacy)<br>|
| Experimental: Experienced LLA - controls<br>Experienced lower-limb amputees that will be tested with a 4-week interval. No intervention. This group will be matched to the group of experienced lower-limb amputees. | Other: Rehabilitation Intervention<br>* Strength, flexibility, endurance, balance, mobility, (self-efficacy)<br>|
| Experimental: New LLA learning to use prosthesis<br>New lower-limb amputees that complete a 8-11 weeks semi-structured individualized rehabilitation regime with extensive testing before and after the intervention. | Other: Rehabilitation Intervention<br>* Strength, flexibility, endurance, balance, mobility, (self-efficacy)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 4-8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation, Prosthetic mobility, Outcome measures