Isokinetic Parameters and the Amputee Mobility Predictor Scale

Completed

• Conditions: Amputation, Traumatic
• Interventions: Diagnostic Test: İsokinetic assessment

• Registration Number: NCT05188599
• Lead Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Brief 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.

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 Timeline

• Study First Submitted: 2021-12-10
• Study First Submitted QC: 2021-12-27
• Study First Posted: 2022-01-12
• Study Start: 2022-03-01
• Primary Completion: 2022-04-29
• Study Completion: 2022-04-29
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-12
• Last Update Posted: 2022-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Amputee patients	İsokinetic assessment	age between 18-65 years, (b) time after amputation ≥ 6 months, (c) unilateral or bilateral amputation above the ankle level

Primary Outcome Measures

Name	Time	Method
Amputee mobility predictor	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.
Isokinetic proprioception	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
Isokinetic muscle strength	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

Trial Locations

Locations (1)

Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital; 🇹🇷 Ankara, Turkey