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NCT Number: NCT05188599

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Ankara, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

İsokinetic assessment

Diagnostic Test

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

Primary outcomes

  1. 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

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Other

Registry information

Official study title

Are There Any Relationship Between Isokinetic Parameters and the Amputee Mobility Predictor Scale?

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 12, 2022
Registry last updated
May 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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