- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05188599
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
Completed
Conditions
Intervention / Treatment
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
Observational
Enrollment (Actual)
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
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Ankara, Turkey
- Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
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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
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 |
Intervention / Treatment |
---|---|
Amputee patients
age between 18-65 years, (b) time after amputation ≥ 6 months, (c) unilateral or bilateral amputation above the ankle level
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Isokinetic assessments of hip flexor and extensor muscle strength and proprioception wiill be performed
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What is the study measuring?
Primary Outcome Measures
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
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Through study completion, an average of 1 month
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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
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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.
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)
March 1, 2022
Primary Completion (Actual)
April 29, 2022
Study Completion (Actual)
April 29, 2022
Study Registration Dates
First Submitted
December 10, 2021
First Submitted That Met QC Criteria
December 27, 2021
First Posted (Actual)
January 12, 2022
Study Record Updates
Last Update Posted (Actual)
May 13, 2022
Last Update Submitted That Met QC Criteria
May 12, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Gaziler
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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