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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05188599
Other study ID # Gaziler
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2022
Est. completion date April 29, 2022

Study information

Verified date May 2022
Source Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date April 29, 2022
Est. primary completion date April 29, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Isokinetic assessment
Isokinetic assessments of hip flexor and extensor muscle strength and proprioception wiill be performed

Locations

Country Name City State
Turkey Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Isokinetic muscle strength 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
Primary Isokinetic proprioception 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
Primary Amputee mobility predictor 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
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