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Clinical Trials/NCT05786690
NCT05786690
Not yet recruiting
Not Applicable

The Effect of Microprocessor Controlled Prostheses on Walking Pattern and Energy Consumption in Above Knee Ampute Patients

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital0 sites34 target enrollmentMarch 23, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Amputation, Traumatic
Sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Enrollment
34
Primary Endpoint
6MWT
Status
Not yet recruiting
Last Updated
3 years ago

Overview

Brief Summary

The aim of this study was to investigate MIC and non-MIC prostheses in terms of gait pattern and energy consumption in above-the-knee amputee patients.

Detailed Description

Background: The use of microprocessor controlled (MIC) prostheses has increased in recent years, but the number of studies on gait pattern and energy consumption in above-the-knee amputee patients is very low. Objective: The aim of this study was to investigate MIC and non-MIC prostheses in terms of gait pattern and energy consumption in above-the-knee amputee patients. Methods: This observational clinical study included 34 unilateral above-the-knee amputees, separated into two groups as Group 1 (n:17) using MIC prosthesis, and Group 2 (n:17) using non-MIC prosthesis. The patients were compared in terms of gait pattern, gait capacity, energy consumption, mobility, quality of life, and prosthesis satisfaction levels according to the type of prosthesis. 3D gait analysis, exercise tolerance test, Short Form 36 (SF-36) Health Survey Questionnaire, Locomotor Capabilities Index-5 (LCI-5), Satisfaction with Prosthesis Questionnaire (SAT-PRO) and six-minute walk test (6MWT) were used as evaluation criteria.

Registry
clinicaltrials.gov
Start Date
March 23, 2023
End Date
June 2, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Yasin Demir

Associated Professor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • as voluntary participation in the study
  • age ≥18 years
  • having a unilateral above-the-knee amputation
  • the ability of independent ambulation in the community
  • at least 6 months since the amputation
  • use of the current prosthesis for at least 8 weeks

Exclusion Criteria

  • unwillingness to participate in the study
  • age \<18 years
  • limb length discrepancy of ≥2 cm
  • the presence of contracture or deformity
  • additional amputation
  • neuromuscular disease or comorbidity that may interfere with the study follow-up period of \< 6 months since the amputation
  • use of the current prosthesis for \< 8 weeks
  • being uncooperative

Outcomes

Primary Outcomes

6MWT

Time Frame: through study completion, an average of one and a half months

6 minute walk test

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