The Effect of Microprocessor Controlled Prostheses on Walking Pattern and Energy Consumption
NCT ID: NCT05786690
Last Updated: 2023-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
34 participants
OBSERVATIONAL
2023-03-23
2023-06-02
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Group 1
17 patients with MIC prosthesis,
Interventions
the temporospatial and kinematic gait characteristics
Group 2
17 patients with non-MIC prosthesis,
Interventions
the temporospatial and kinematic gait characteristics
Interventions
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Interventions
the temporospatial and kinematic gait characteristics
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
OTHER
Responsible Party
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Yasin Demir
Associated Professor
Principal Investigators
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Yasin Demir, Assoc. Prof.
Role: PRINCIPAL_INVESTIGATOR
Gaziler PMR ER Hospital Ankara Turkiye
Central Contacts
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Other Identifiers
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34
Identifier Type: -
Identifier Source: org_study_id
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