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NCT05786690 Clinical Trial

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

Gait Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05786690
Other study ID # 34
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 23, 2023
Est. completion date June 2, 2023

Study information
Verified date March 2023
Source Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Contact Yasin Demir
Phone +905303244119
Email dr_yasindemir@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 34
Est. completion date June 2, 2023
Est. primary completion date May 23, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Interventions
the temporospatial and kinematic gait characteristics

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary 6MWT 6 minute walk test through study completion, an average of one and a half months
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