NCT05786690

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

March 23, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2023

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2023

Completed
Last Updated

March 27, 2023

Status Verified

March 1, 2023

Enrollment Period

2 months

First QC Date

March 14, 2023

Last Update Submit

March 24, 2023

Conditions

Amputation, TraumaticGait

Outcome Measures

Primary Outcomes (1)

  • 6MWT

    6 minute walk test

    through study completion, an average of one and a half months

Study Arms (2)

Group 1

17 patients with MIC prosthesis,

Other: Interventions

Group 2

17 patients with non-MIC prosthesis,

Other: Interventions

Interventions

InterventionsOTHER

the temporospatial and kinematic gait characteristics

Also known as: Gait analysis
Group 1Group 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

lower limb amputation

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Amputation, Traumatic

Interventions

MethodsGait Analysis

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Investigative TechniquesGaitPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisPhysical Functional PerformancePhysical FitnessHealthPopulation Characteristics

Study Officials

  • Yasin Demir, Assoc. Prof.

    Gaziler PMR ER Hospital Ankara Turkiye

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yasin Demir

CONTACT

+905303244119dr_yasindemir@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor

Study Record Dates

First Submitted

March 14, 2023

First Posted

March 27, 2023

Study Start

March 23, 2023

Primary Completion

May 23, 2023

Study Completion

June 2, 2023

Last Updated

March 27, 2023

Record last verified: 2023-03