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
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Amputation, Traumatic
• Gait

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