ClinicalTrials.gg
Status unknownNCT05786690Updated Mar 27, 2023

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

An observational study in Amputation, Traumatic and Gait, sponsored by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-27.

Sponsored by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital · Observational

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
34
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Amputation, Traumatic
  • Gait

Browse trials for

03

In context

Amputation, Traumatic

112 studies on the registry are indexed under Amputation, Traumatic; 24 are open to participants now.

This study's planned enrollment of 34 is close to the median of 37 across 34 observational studies indexed under Amputation, Traumatic.

Browse Amputation, Traumatic studies →

Lead sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital is the lead sponsor of 85 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

lower limb amputation

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
34 participants (estimated)
Patient registry
No

Groups and cohorts

  • Group 1

    17 patients with MIC prosthesis,

    Other: Interventions

  • Group 2

    17 patients with non-MIC prosthesis,

    Other: Interventions

Interventions

  • OtherInterventions

    the temporospatial and kinematic gait characteristics

    Also known as: Gait analysis

06

What researchers measure

Primary outcomes

  1. 6MWT

    6 minute walk test

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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05786690
Lead sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Responsible party
Yasin Demir (Associated Professor, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital) — Principal investigator
First posted
Mar 27, 2023
Start date
Mar 23, 2023 (estimated)
Primary completion
May 23, 2023 (estimated)
Completion
Jun 2, 2023 (estimated)
Last update
Mar 27, 2023

Study contacts

Yasin Demir
Contact
dr_yasindemir@yahoo.com
+905303244119
Yasin Demir, Assoc. Prof.
principal investigator · Gaziler PMR ER Hospital Ankara Turkiye

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion