Status:
COMPLETED
Prosthetic Use, Mobility and Daily Functioning
Lead Sponsor:
Oslo Metropolitan University
Collaborating Sponsors:
Sophies Minde Ortopedi
UniCare Bakke AS
Conditions:
Lower Leg Amputations
Eligibility:
All Genders
18+ years
Phase:
NA
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 a...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04904003
Start Date
April 9 2021
End Date
June 15 2022
Last Update
October 12 2022
Active Locations (2)
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1
Unicare Bakke
Halden, Akershus, Norway, 1765
2
OsloMet
Oslo, Norway, 0130