An Early Phase 1 interventional study of DeXtreme training (error-enhancement) in Chronic Stroke, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed at 1 site in Belgium. Open to participants aged Up to 85 Years. Per ClinicalTrials.gov, last updated 2023-03-31.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Early Phase 1, Interventional, and Treatment
Even in a chronic phase after stroke, most patients have difficulty moving the affected arm, resulting in limitations in simple tasks in daily living, most frequently limiting reaching task. In the chronic phase, significant improvements are usually no longer observed. Nevertheless, even these patients can still improve their functional abilities due to exercise-dependent plasticity.
A new device was developed, the deXtreme robot, a rehabilitation device that offers error-enhancement approach during three-dimensional movements. The goal error-enhancement is to elicit better accuracy, stability, fluidity and range of motion during reaching. games are projected on a screen, requiring 3D active reaching movements. The duration of the study for a single participant will be 7 consecutive working days, including 1 day of pre-intervention assessment, 5 days of training and 1 day of post-intervention assessment. The overall aim of this project is to gain knowledge into the potential of error-enhancement robot training in patients with upper limb impairments in the chronic phase after stroke. Hypothesizing that the 5-day training will have a positive effect on both the robotic and clinical outcome measures.
The overall aim of this study is to gain knowledge into the potential of error-enhancement robot training in patients with upper limb impairments in the chronic phase after stroke. Error-enhancement is characterized as unexpected external perturbation forces acting upon the upper limb during a reaching movement, causing the upper limb to deflect from the reaching pathway, and this results in errors. If one allows for repetitive reaching performance with the same systematic perturbation forces, then a decrease in errors and improvement in movement performance is expected. The robot used for the training, the DeXtreme, is a CE marked rehabilitation device that offers this error-enhancement approach during three-dimensional movements.
The pilot study has a pre-post intervention design, recruiting 20 patients in the chronic phase after stroke. Error-enhancement treatment will be provided on day 2 to 6, i.e., for 5 consecutive days and will consist of facilitation of accuracy, range of movement, stability, and smoothness. Algorithms provide progression in terms of accuracy, range of movement, stability and smoothness, depending upon the performance of the patient.
The treatment will start with the installation of the patient and a warming up, followed by a first block of DeXtreme training. Then a short break is given followed by a short conventional therapy session. The content of the conventional therapy will involve active relaxation, focusing on stretching and (auto-)mobilisation. Afterwards, a second block of training with the DeXtreme follows, and it finishes with a cooling down. A therapist trained by the company will provide all assessment and training sessions. Training with the DeXtreme is additional to the conventional therapy the patient receives. Therefore, a diary of their conventional therapy sessions will be kept, and the content will be reviewed with the patient.
Advancements in upper limb motor function and activity will be evaluated through a triad of measurements including clinical and patient-reported outcomes, error-enhancement variables, and objective quantification of uni- and bimanual sensorimotor function by making use of the KINARM robotic manipulandum. These tests and questionnaires are administered on day 1 and day 7.
The aim of the study is to investigate whether patients with upper limb impairments in a chronic phase after stroke clinical and meaningful benefits from 5 hours DeXtreme training. In addition, it is examined whether improvements in the upper limb outcome is the result of restitution or compensation in the upper limb function.
In order to evaluate whether a randomized controlled trial is useful, the investigators will analyse the outcomes of our study twofold. (1) At group level, the investigators will calculate mean and standard deviation or median and interquartile range (based on whether data is normally distributed or not) and evaluate whether pre- to post-intervention scores for clinical, deXtreme and objective outcomes are significantly improved by means of Wilcoxon signed rank test (nonparametric), at a 0,05 significance level. Each p-value will be interpreted in a descriptive manner.
(2) At patient level, the investigators will evaluate how many patients (%) achieve a clinically significant improvement based on the therapy provided.
To see if the improvement might be explained by restitution or compensation, the association between the scores of the MAL-14 and the visually guided reaching task of the KINARM will be explored by Spearman correlations.
Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 959 studies on the registry; 263 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Training (error-enhancement): 5 consecutive days, 1 hour per day
Device: DeXtreme training (error-enhancement)
15-20 min DeXtreme - 15 min conventional therapy - 15-20 min DeXtreme
Action research arm test
Evaluating UL functional ability, providing information whether improvement in impairment (FMA-UE) results in increased activity level. Internationally accepted outcome measure for stroke studies, and extensive experience available in the research group. min-max: 0-57 (higher = better)
Time frame: day 1(pre) - day 7 (post)
Fugl-Meyer motor assessment upper extremity
Evaluating UL motor impairment (shoulder, elbow, wrist, hand and fingers), ability to measure restoration of function due to improved quality of movement. Internationally accepted outcome measure for stroke studies, and extensive experience available in the research group. min-max: 0-66 (higher = better)
Time frame: day 1(pre) - day 7 (post)
Kinarm: visually guided reaching task
Assessment of motor function using a 4-target centre-out reaching task on the Kinarm End-Point Lab.
Time frame: day 1(pre) - day 7 (post)
DeXtreme: reaching task - Market stand
Assessment of motor function using reaching tasks on the DeXtreme robot (range of motion and accuracy).
Time frame: day 1(pre) - day 7 (post)
DeXtreme: reaching task - Alchemist
Assessment of motor function using reaching tasks on the DeXtreme robot (stability and smoothness).
Time frame: day 1(pre) - day 7 (post)
Visual analogue scale (VAS) - Pain
A measurement instrument that tries to measure a characteristic that is believed to range across a continuum of values and cannot easily be directly measured. In this case, it is used to determine the pain in the shoulder region. min-max: 0-100 (higher = worse)
Time frame: day 1(pre) - day 7 (post); after treatment (day 2-5)
Motor assessment scale - tonus
A single item of the MAS, general tonus, intended to provide an estimate of muscle tone of the arm/hand on the affected side. Min-max: 0-6 (4 = normal tone, \> 4 = hyper tone; \< 4 = hypo tone)
Time frame: day 1(pre) - day 7 (post); after treatment (day 2-5)
Kinarm: sensory processing task
Newly-developed task on the Kinarm End-Point Lab used to assess passive and active sensory processing.
Time frame: day 1(pre) - day 7 (post)
Motor assessment scale - upper limb
A performance-based scale to assess everyday upper limb motor functions, based on a task-oriented approach to evaluation that assesses performance of functional tasks. min-max: 0 - 18 (higher = better)
Time frame: day 1(pre) - day 7 (post)
Stroke impact scale - Hand
Evaluating perceived function and quality of life with stroke: perceived hand function, scoring difficulty of five manual activities using the most affected hand. Experience present in the research group. min-max: 0-100 (higher = better)
Time frame: day 1(pre) - day 7 (post)
Motor Activity Log - 14 items
Evaluating the amount of use and the quality of the movement of the more-affected arm during functional activities, through a structured interview (patient reported outcome). min-max: 0-5 (higher = better)
Time frame: day 1(pre) - day 7 (post)
Kinarm: arm position matching task
Assessment of limb position sense using a 9-target mirror-matching task on the Kinarm Exoskeleton Lab.
Time frame: day 1(pre) - day 7 (post)
Plan to share: Undecided
Ran from Jan 2022 to primary completion in Nov 2022, 9 months.
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