Isokinetic Parameters and the Amputee Mobility Predictor Scale

NCT05188599 | Completed

• 1 other identifier: Gaziler
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Amputation, Traumatic

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

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

Interventions

İsokinetic assessment DIAGNOSTIC_TEST

Isokinetic assessments of hip flexor and extensor muscle strength and proprioception wiill be performed

Amputee patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 43 patients with lower limb amputations

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead

Study Sites (1)

Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Amputation, Traumatic

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: January 12, 2022
• Study Start: March 1, 2022
• Primary Completion: April 29, 2022
• Study Completion: April 29, 2022
• Last Updated: May 13, 2022

Record last verified: 2022-05

Locations

TU (1)