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

Not yet recruiting

• Conditions: Amputation, Traumatic; Gait
• Interventions: Other: Interventions

• Registration Number: NCT05786690
• Lead Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

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.

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-14
• Study Start: 2023-03-23
• Study First Submitted QC: 2023-03-24
• Last Update Submitted: 2023-03-24
• Study First Posted: 2023-03-27
• Last Update Posted: 2023-03-27
• Primary Completion: 2023-05-23
• Study Completion: 2023-06-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Interventions	17 patients with MIC prosthesis,
Group 2	Interventions	17 patients with non-MIC prosthesis,

Primary Outcome Measures

Name	Time	Method
6MWT	through study completion, an average of one and a half months	6 minute walk test