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Clinical Trials/NCT04904003
NCT04904003
Completed
N/A

Prosthetic Use, Mobility and Daily Functioning

Oslo Metropolitan University2 sites in 1 country60 target enrollmentApril 9, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Lower Leg Amputations
Sponsor
Oslo Metropolitan University
Enrollment
60
Locations
2
Primary Endpoint
The Amputee Mobility Predictor (AMP).
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
April 9, 2021
End Date
June 15, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Oslo Metropolitan University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

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

Outcomes

Primary Outcomes

The Amputee Mobility Predictor (AMP).

Time Frame: 4-8 weeks

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.

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

Time Frame: 4-8 weeks

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.

Study Sites (2)

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