Amputation, TraumaticNCT05786690
The Effect of Microprocessor Controlled Prostheses on Walking Pattern and Energy Consumption
An observational study of Amputation, Traumatic and Gait, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation, Traumatic, Gait
- What is being tested?
- Interventions
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 23 Mar 2023to 2 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: lower limb amputation
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
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.
- Conditions
- Amputation, Traumatic, Gait
- Being tested
- Interventions
- Medical subject headings
- Amputation, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionsOther
Also called Gait analysis
the temporospatial and kinematic gait characteristics
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | 17 patients with MIC prosthesis, Receives: Other: Interventions | |
| Group 2 | 17 patients with non-MIC prosthesis, Receives: Other: Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
6MWT
6 minute walk test
Measured: through study completion, an average of one and a half months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start23 Mar 2023 (estimated)
- Primary completion23 May 2023 (estimated)
- Study completion2 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amputation, TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Investigators
- Yasin Demir, Assoc. Prof., Principal investigator, Gaziler PMR ER Hospital Ankara Turkiye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786690
- Sponsor's protocol ID
- 34
- Status last verified
- Mar 2023
- First submitted
- 14 Mar 2023
- Last updated
- 27 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Microprocessor Controlled Prostheses on Walking Pattern and Energy Consumption in Above Knee Ampute Patients
- ClinicalTrials.gov ID
- NCT05786690
- Acronym / sponsor ID
- 34
- Conditions
- Amputation, Traumatic, Gait
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 23 Mar 2023 (estimated)
- Primary completion
- 23 May 2023 (estimated)
- Study completion
- 2 Jun 2023 (estimated)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Interventions17 patients with MIC prosthesis, |
| Group 2 | – | Other: Interventions17 patients with non-MIC prosthesis, |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- lower limb amputation
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- unwillingness to participate in the study
- age <18 years
- limb length discrepancy of ≥2 cm
- the presence of contracture or deformity
- additional amputation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionsAlso: Gait analysisthe temporospatial and kinematic gait characteristics | Other | Group 1, Group 2 |
Primary outcome
6MWT
Time frame: through study completion, an average of one and a half months
6 minute walk test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasin Demir, Assoc. Prof. principal investigator
Gaziler PMR ER Hospital Ankara Turkiye
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation, Traumatic and Gait, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yasin Demir (+905303244119, dr_yasindemir@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6MWT (time frame: through study completion, an average of one and a half months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2023.