Catalog of Regulatory Science Tools to Help Assess New Medical Devices
The targeted Box and Blocks Test (tBBT) is a performance-based clinical outcome assessment tool that elicits ecologically representative actions including movement initiation, grasp, transport, and controlled release of objects during an upper limb functional task. It is a derivative of the conventional BBT  and modified BBT[2, 3]. Participant performance in the tBBT is quantified by task completion time.
Instructions for use detail the set-up and instructions for the participants. Read these instructions prior to administering the test.
This video demonstrates how to administer the targeted Box and Blocks Test (tBBT) to a patient or participant. The test is a performance-based clinical outcome assessment tool that elicits ecologically representative actions, including movement initiation, grasp, transport, and controlled release of objects during an upper limb task.
The targeted Box and Blocks Test (tBBT) is a performance-based clinical outcome assessment tool that can be used as a clinical endpoint in upper limb transradial prosthetic device clinical trials or as an evaluative metric of change in functional ability during clinical rehabilitation for the upper limb transradial prothesis user population.
This tool can also be used by medical device companies as a baseline measurement of gross manual dexterity and control for individuals previously using a myoelectric device in order to assess change in performance when using a neural-controlled and/or osseointegrated prosthetic device. Patient performance in the tBBT is quantified by task completion time.
Normative scores for the tBBT were established in a first study comparing upper body movements elicited as individuals without an upper limb impairment/disability performed the tBBT and the conventional BBT.
The median (interquartile range (IQR), max, min) of completion time for the tBBT was 24.8 seconds (21.6 seconds to 28.5 seconds, 36.5 seconds, 18.0 seconds). In comparison to the conventional BBT, this study also showed that gross body movements during the tBBT were closer to movements of able-bodied individuals performing activities of daily living (e.g., opening a door, pour liquid from a container, transfer weighted objects).
To conduct an initial evaluation of the tBBT in the upper limb prosthesis user population, a convenience sample of n = 8 transradial myoelectric prosthesis users (3F/5M; mean age 46.3 ± 14.3 years) participated in a second study.
Participants were timed as they performed two trials each of the tBBT (in both a standing and seated position) and select tasks from the Activities Measure for the Upper Limb Amputees (AM-ULA) and the Capacity Assessment of Prosthesis Performance for the Upper Limb (CAPPFUL). Average time of trials was used to calculate the Pearson correlation coefficients between tBBT and each task performed from the CAPPFUL and AM-ULA.
Additional properties (such as known-group validity and test-retest reliability) should be determined to fully characterize the tBBT measure. Convergent validity should also be confirmed in a larger sample size.
- Preliminary evaluation data
- Instructions for Use
- Computer-aided design (CAD) - recommend using a rigid plastic material on a computer numerical control (CNC) machine
- Normative scores for tBBT
- Mathiowetz, V., et al., Adult norms for the Box and Block Test of manual dexterity. Am J Occup Ther, 1985. 39(6): p. 386-91.
- Hebert, J.S. and J. Lewicke, Case report of modified Box and Blocks test with motion capture to measure prosthetic function. Journal of Rehabilitation Research & Development, 2012. 49(8): p. 1163-1174.
- Hebert, J.S., et al., Normative data for modified Box and Blocks test measuring upper-limb function via motion capture. Journal of Rehabilitation Research & Development, 2014. 51(6): p. 919-931.
In addition to citing relevant publications, please reference the use of this tool using DOI: 10.5281/zenodo.6628883.
For more information
- Video: Targeted Box and Blocks Test (tBBT)
- Catalog of Regulatory Science Tools to Help Assess New Medical Devices