Isokinetic Parameters and the Amputee Mobility Predictor Scale

May 12, 2022 updated by: Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Are There Any Relationship Between Isokinetic Parameters and the Amputee Mobility Predictor Scale?

There is very limited research examining isokinetic parameters and activity level in patients with amputation.. Therefore, the aims of this study were to illustrate isokinetic measurements including strength and proprioception and to analyze the correlation between those isokinetic parameters and activity level and to predict amputee mobility score. It is hypothesized that muscle strength and proprioception were associated with activity level and could be used to estimate amputee mobility scale score in patients with amputation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Isokinetic measurements are used in the rehabilitation of amputee patients and to evaluate the effectiveness of rehabilitation. The parameters that are frequently looked at in these measurements are isokinetic muscle strength and proprioception. There is very limited research examining isokinetic parameters and activity level in patients with amputation.. Therefore, the aims of this study were to illustrate isokinetic measurements including strength and proprioception and to analyze the correlation between those isokinetic parameters and activity level and to predict amputee mobility score. We hypothesized that muscle strength and proprioception were associated with activity level and could be used to estimate amputee mobility scale score in patients with amputation

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A total of 43 patients with lower limb amputations

Description

Inclusion Criteria:

  • Aged 18-65 years
  • Time after amputation ≥ 6 months
  • Unilateral or bilateral amputation above the ankle level

Exclusion Criteria:

  • Upper extremity amputation
  • The presence of musculoskeletal or neurological disease that could cause functional impairment other than amputation
  • The presence of neurological deficit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Amputee patients
age between 18-65 years, (b) time after amputation ≥ 6 months, (c) unilateral or bilateral amputation above the ankle level
Diagnostic test: İsokinetic assessment
Isokinetic assessments of hip flexor and extensor muscle strength and proprioception wiill be performed

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Isokinetic muscle strength
Time Frame: Through study completion, an average of 1 month
Muscle strength will be assessed for flexion and extension of the hip using a computer-assisted isokinetic system (CYBEX) in the isokinetic performance laboratory
Through study completion, an average of 1 month
Isokinetic proprioception
Time Frame: Through study completion, an average of 1 month
Isokinetic proprioception will be measured with the CYBEX device. The hip joint is chosen because the most proximal level amputation will be the above-knee level
Through study completion, an average of 1 month
Amputee mobility predictor
Time Frame: Through study completion, an average of 1 month
Amputee mobility predictor (AMP) is one of the performance-based outcome measures commonly used prior to prosthetic fitting and predict function following prosthetic prescription.The AMP is a 21-item tool for predicting the level of ambulation by assessing static and dynamic balance, transfers, and gait. With this scale, unilateral patients can be evaluated with or without prosthesis. However, activity level of bilateral amputees can only be predicted if they have prostheses. In this study, AMP evaluation of all patients will be performed by a physiotherapist with 10 years of experience in amputee rehabilitation, blinded to other clinical information.
Through study completion, an average of 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 29, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 29, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 27, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Gaziler (Other Identifier: Gaziler Fizik Tedavi ve Rehabilitasyon SUAM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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