Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT04904003
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04904003
Study Brief:
Protocol Section:
NCT04904003