Amputation, Traumatic Clinical Trial
Official title:
Are There Any Relationship Between Isokinetic Parameters and the Amputee Mobility Predictor Scale?
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 |
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital | Ankara |
Lead Sponsor | Collaborator |
---|---|
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital |
Turkey,
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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