The Effect of Microprocessor Controlled Prostheses on Walking Pattern and Energy Consumption

NCT ID: NCT05786690

Last Updated: 2023-03-27

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-23

Study Completion Date

2023-06-02

Brief Summary

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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

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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.

Conditions

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Amputation, Traumatic Gait

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

17 patients with MIC prosthesis,

Interventions

Intervention Type OTHER

the temporospatial and kinematic gait characteristics

Group 2

17 patients with non-MIC prosthesis,

Interventions

Intervention Type OTHER

the temporospatial and kinematic gait characteristics

Interventions

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Interventions

the temporospatial and kinematic gait characteristics

Intervention Type OTHER

Other Intervention Names

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Gait analysis

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yasin Demir

Associated Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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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Yasin Demir

Role: CONTACT

+905303244119

Other Identifiers

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34

Identifier Type: -

Identifier Source: org_study_id

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