Comparison of Prosthetic Assessment Tools and Factors Influencing the Outcome
Condition: Amputation; Prosthesis User
Study type: Observational

Summary: 
      Background and rational:

      A large number of instruments exists to assess upper limb prosthetic function. However, they
      differ substantially in terms of psychometric properties and content. Furthermore, there is
      no "gold standard" and nearly every single center uses a unique set of instruments. This fact
      prevents the linking of the commonly small (due to the limited number of patients in each
      center) data sets of different centers and makes comparisons between different fittings or
      treatment protocols difficult. To generate accepted evidence, we need large data sets with
      similar outcomes. With remarkable progress made in prosthetic research and rehabilitation in
      the recent years, the need to evaluate the impact of this intervention on daily life,
      including productivity, self-care and leisure becomes increasingly relevant. Moreover,
      self-reported instruments and observation-based instruments exist, but there is a lack of
      data if, for example, the self-reported instrument (which is easier and less
      health-professional's-time-consuming to perform) could "replace" a performance or
      observation-based instrument.

      Therefore, the aim of this study is to determine psychometric properties of the existing
      instruments (SHAP, DASH, SF-36 and ACMC) in a large international data set, to explore
      possible linkage between self-reported and performance or observation-based instruments and
      to develop state-of-the art recommendations/points to consider on how to assess functioning
      in prosthetic care.
    

Detailed description: 
      Background and rational:

      A large number of instruments exists to assess upper limb prosthetic function. However, they
      differ substantially in terms of psychometric properties and content. Furthermore, there is
      no "gold standard" and nearly every single center uses a unique set of instruments. This fact
      prevents the linking of the commonly small (due to the limited number of patients in each
      center) data sets of different centers and makes comparisons between different fittings or
      treatment protocols difficult. To generate accepted evidence, we need large data sets with
      similar outcomes. With remarkable progress made in prosthetic research and rehabilitation in
      the recent years, the need to evaluate the impact of this intervention on daily life,
      including productivity, self-care and leisure becomes increasingly relevant. Moreover,
      self-reported instruments and observation-based instruments exist, but there is a lack of
      data if, for example, the self-reported instrument (which is easier and less
      health-professional's-time-consuming to perform) could "replace" a performance or
      observation-based instrument.

      Therefore, the aim of this study is to determine psychometric properties of the existing
      instruments in a large international data set, to explore possible linkage between
      self-reported and performance or observation-based instruments and to develop state-of-the
      art recommendations/points to consider on how to assess functioning in prosthetic care.
      Projects exploring outcome assessments should have a broad basis and target different patient
      populations. To be able to generalize the outcome of the study for the European population,
      this study is planned as a multi-centre study. Also, having a sufficient number of subjects
      to calculate statistical relationships is otherwise not possible due the limited number of
      patients being treated at most centers.

      Included patients:

        -  age: 16-85 years

        -  major uni-lateral amputation of the upper extremity (includes amputation of the hand,
           forearm, upper arm and at shoulder level)

        -  normal hand function of the other side (in case of doubt: SHAP score ≥ 95)

        -  no major neurologic or untreated psychological disorders

        -  fitted with an active prosthesis (myo, body-powered or hybrid) for at least 6 months

      Used Assessments:

        -  Southampton Hand Assessment Procedure (SHAP): The Southampton Hand Assessment Procedure
           (SHAP) is a clinically validated hand function test developed to assess the
           effectiveness of upper limb prostheses. The SHAP is made up of 6 abstract objects and 14
           Activities of Daily Living (ADL). Each task is timed by the participant, so there is no
           interference or reliability on the reaction times of the observer or clinician. The SHAP
           Index of Function score is used for comparison, which is a number that provides an
           overall assessment of hand function. SHAP scores do not plateau at 100, instead scores
           greater than 100 can be achieved if a participant is exceptionally quick at a given task
           or series of tasks. Scores less than 100 are an indication of how impaired a
           participant's hand function is. In general, scores between 95 and 105 are considered
           normal.

        -  Disabilities of Arm, Shoulder and Hand Questionnaire (DASH): The DASH is a
           questionnaire, where patients are asked to rate their (bimanual) performance in daily
           life. It has been validated for use in patients with musculoskeletal diseases and
           injuries to the arm. A score of 100 indicates the worst and 0 indicates the best hand
           function.

        -  Short Form -36 Quality of Life Questionnaire (SF-36): We will use the SF-36 Health
           Survey 4-week recall version. The questionnaire addresses eight independent subscales:
           physical functioning, physical role functioning, bodily pain, general health, vitality,
           social role functioning, emotional role functioning, and mental health. Each subscale
           ranges from 0 to 100. Based on the subscales, two superior physical and mental component
           summary scales can be identified. These have mean values of 50 and an SD of 10. A
           (German) patient with a psychological sum scale of 65 exhibits above average mental
           health compared with age-matched and sex-matched Germans.

        -  Open questions concerning demographic data and prosthesis-related questions (~15): These
           questions are used to determine further factors that may influence the outcome of
           self-rated and performance-based tests. They include factors that are already known to
           influence upper extremity function or perceived disability (e.g rate at amputation, time
           since amputation, dominant vs. non-dominant hand), as well as factors that may influence
           the outcome, but were not studied before in sufficient detail (as living alone).

        -  Assessment of Capacity of Myoelectric control (ACMC): The "Assessment of Capacity for
           Myoelectric Control" (ACMC) is an observational assessment developed to assess the
           ability of a prosthesis user to control a myoelectric prosthetic hand. Each item in the
           ACMC is an observable prosthetic hand movement, such as timing during grasping, or an
           observable prosthetic hand movement in relation to other body parts, such as uses the
           prosthesis over the shoulder. The ACMC assesses how skillful a prosthesis hand user
           performs different prosthetic hand movements when performing a bimanual activity. To
           perform the ACMC, a two-day training course is required. As not all participating
           centres have trained professionals, the use of the ACMC is not mandatory.

      Data collection:

        -  As this is a cross-sectional study, all assessments are performed at one point in time
           (maximum of 2 months in between the different assessments).

        -  The participating centers can collect all data by themselves and send (anonymized) data
           sets to the Medical University of Vienna (MUV). Otherwise, they can invite patients and
           an experienced physical therapist from MUV will visit the center to do the assessments.

      Research questions and statistical considerations:

        1. To determine psychometric properties of the existing instruments in a large
           international data set --> Linkage of data from different centers, psychometric
           properties; planned analyses: descriptive statistics, correlation, principal components
           analyses and Rasch analyses

        2. To explore possible linkage between self-reported and performance or observation-based
           instruments. planned analyses: Regression analyses

        3. To develop state-of-the art points to consider on how to assess functioning in
           prosthetic care

      Anticipated sample size:

      The aim of this study is to get a (representative) sample of the European prosthesis using
      population, which presents the major the reason for the multi-centre study design. The
      planned sample size is 100-200 amputees fitted with an active prosthesis. This number should
      alow proper statistic calculations of the influence of the co-variants, but also be feasible
      with the number of centres participating.
    

Intervention name(s): Functional tests and self-reported questionnaires
Intervention type(s): Other
Intervention description(s): In this observational study no intervention is initiated. Patients included are only assessed with the non-invasive tests described earlier.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study includes upper-limb amputees who are fitted with an acitve prosthesis. it is
        intented to have a diverse sample concerning age, gender, time since amputation,...
      
Keywords: standardized test; prosthesis; upper limb amputation; rehabilitation outcome