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Clinical Trials/ACTRN12621001757808
ACTRN12621001757808
Completed
未知

Clinical, biomechanical adaptation of people after unilateral transfemoral amputation or amelia of the lower limb to gait using advanced prosthetic solutions - a prospective, single-center, clinical, controlled, observational study.

Wroclaw Medical University0 sites34 target enrollmentDecember 22, 2021

Overview

Phase
未知
Intervention
Not specified
Conditions
Musculoskeletal - Other muscular and skeletal disorders
Sponsor
Wroclaw Medical University
Enrollment
34
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

1 Research Question:The purpose of this study is to determine the relationship between torque values, torque symmetry of the hip flexor and extensor muscles of the intact and amputated limb, and the degree of gait asymmetry in transfemoral amputees (TFA). Additional Objectives To evaluate gait symmetry in terms of changes in lower limb and pelvic joint ranges of motion (kinematic) and ground reaction force (dynamic) in patients following TFA. 2 Background Information:Assessment of gait symmetry is one of the main criteria for evaluating the motor rehabilitation process of patients with various musculoskeletal disorders. For patients with TFA, gait parameters are evaluated by relating the obtained amputation data to data for the whole limb or to data of healthy subjects. 3 Participant characteristics: Fourteen adults with unilateral TFA participated in the experiment.All participants underwent gait analysis, but only eight participated in the assessment of muscle torque acting on the hip joints. Six patients did not participate in the muscle torque assessment because their thigh stump was too short. 4 Key findings:This study showed consistent evidence of a significant association between hip extensors and gait asymmetry. The conclusions drawn from the mean value of the results obtained for the study group of patients with TFA are limited by errors due to multiple factors. 5 Limitations: Small number of subjects studied.

Registry
who.int
Start Date
December 22, 2021
End Date
April 30, 2020
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Wroclaw Medical University

Eligibility Criteria

Inclusion Criteria

  • Inclusion criteria will include:
  • 1\. Loss of lower limb at the level of the thigh.
  • 2\. the use of a prosthetic limb in addition to daily living.
  • 3\. use of the currently used prosthesis for at least 6 months.
  • 4\.The ability to walk a distance of not less than 20 metres without the use of elbow crutches.
  • 5\.Congenital lower limb impingement consisting of absence of the knee joint and structures below.
  • 6\.Medicare Functional Classification K level 3 or 4\.
  • 7\.Informed consent for the study.
  • Key inclusion criteria Healthy, age\-matched volunteers: Inclusion criteria will include:
  • 1\. No history of musculoskeletal or nervous system disorders on the day of the study.

Exclusion Criteria

  • The exclusion criteria will be pain in the stump or lower limbs and chronic diseases that could affect the fitness of the musculoskeletal system in terms of satiation:
  • 1\. Cancer relapse.
  • 2\. Injury to the locomotor system.
  • 3\. Exacerbation of thromboembolism (including the antiphospholipid syndrome).
  • 4\. Pain in the area of the lumbar spine.
  • 5\. Root pain in the course of discopathy.
  • 6\. Cognitive dysfunction

Outcomes

Primary Outcomes

Not specified

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