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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gait; Amputation, Traumatic
• Intervention / Treatment: Other: Interventions

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 Type: Observational
• Enrollment (Anticipated): 34

Contacts and Locations

• Study Contact: Name: Yasin Demir; Phone Number: +905303244119; Email: dr_yasindemir@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

lower limb amputation

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; 17 patients with MIC prosthesis,	Other: Interventions; the temporospatial and kinematic gait characteristics; Other Names: Gait analysis
Group 2; 17 patients with non-MIC prosthesis,	Other: Interventions; the temporospatial and kinematic gait characteristics; Other Names: Gait analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6MWT	6 minute walk test	through study completion, an average of one and a half months

Collaborators and Investigators

• Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
• Investigators: Principal Investigator: Yasin Demir, Assoc. Prof., Gaziler PMR ER Hospital Ankara Turkiye

Study record dates

Study Major Dates

• Study Start (Anticipated): March 23, 2023
• Primary Completion (Anticipated): May 23, 2023
• Study Completion (Anticipated): June 2, 2023

Study Registration Dates

• First Submitted: March 14, 2023
• First Submitted That Met QC Criteria: March 24, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2023
• Last Update Submitted That Met QC Criteria: March 24, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Amputation, Traumatic
• Other Study ID Numbers: 34

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No