Upper limb (arm) difference (congenital/acquired) Musculoskeletal Diseases
Conditions
Interventions
Sampling method: Non-probability sample (convenience sampling, although purposeful sampling is preferable if prevalence and subjects with necessary characteristics [e.g. device wearers versus non-wear
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 3-17 years 2. Wearer or non-wearer of prosthetic device 3. Bilateral level of amputation (only Stage I) 4. Non-disabled children (only Stage I) 5. Parent or legal guardian is willing and able to give permission and informed assent for his or her ward’s participation in the study 6. Free of neurological and musculoskeletal pathology (apart from upper limb (UL) loss or absence for prosthesis users, and as reported by the participants or their clinician) that would impair upper limb motor control during a goal-oriented task execution in a seated position
Exclusion criteria
Exclusion criteria: 1. Any medical conditions, assessed by their treating healthcare professionals, that would contraindicate the use of prosthetic arm prototypes, such as difficulties in breathing, skin abrasions, and musculoskeletal injuries 2. Inability to give the information required or to perform the test tasks 3. Wounds or ulcers in the residuum 4. Transcarpal level of amputation (for Stage II)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoints for all of the outcome measures: baseline only Stage I (n = 15): 1. Qualitative usability testing of breathing control provided by the study participants and their parent(s) or legal guardian via a Likert scale and open-ended questions; patient-reported and researcher observed 2. Published outcome measures such as: 2.1. Baby version of the Southampton Hand Assessment Procedure (babySHAP), a clinically validated hand function test 2.2. University of New Brunswick (UNB) Test of prosthetic function for measuring prosthetic function (observer-rated measure with a dual rating scale used to evaluate performance and spontaneity of use) Stage II (n = 30): 1. Published outcome measures such as: 1.1. Baby version of the Southampton Hand Assessment Procedure (babySHAP), a clinically validated hand function test 1.2. Prosthetic Upper Extremity Functional Index (PUFI) for measuring upper limb-focused functional abilities (observer-rated measure with a dual rating scale used to evaluate performance and spontaneity of use) 1.3. Paediatrics Outcome Data Collection Instrument (PODCI) (or Paediatric QOL Inventory (PedsQL)) test - well-validated musculoskeletal health questionnaires for measuring participation and Quality of Life | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoints for all of the outcome measures: baseline only Stage I (n = 50): Description of demographics and needs analysis using a questionnaire-based survey by the study participants and their parent(s) or legal guardian via questionnaires such as Quebec User Evaluation of Satisfaction with assistive Technology 2.0 (QUEST 2.0) and (Nagaraja et al. 2016) | — |
Countries
India
Outcome results
None listed