Compensatory Kinematic Movement for Reaching Task in Various Directions in After Stroke
Conditions: Cerebral Stroke, Hemiplegia, Spastic
Sponsor: University of Valencia

심의서식1-1 (version 1.0, 2022.07) 
1 
 
 
NCT number: NCT05683158 
Research protocol (Human subject study) 
 
 
 
Compensatory kinematic analysis in various directions after chronic stroke 
 
The inclusion criteria for the participants with stroke were physician-confirmed chronic hemiplegia ( ≥ 6 
months onset), Mini-Mental State Examination ≥ 25, Modified Ashworth Scale (MAS) (biceps ≤ 2, triceps ≤ 
2), ability to sit alone on a chair, and FMA upper extremities score ≥ 21. The healthy participants were 
individuals without any history of neurological or orthopedic diseases.  
- The exclusion criteria were muscle flaccidity, neglect syndrome, orthopaedic diseases, and poor 
coordination.  
* The specific placement of markers 
 
 
- 
Sternum, xyphoid process, Both acromion, C7, T4, elbow(lateral and medial epicondyle), wrist (lateral and 
medial styloid process), finger 3rd MCP 
The seated reaching task posture is as follows: 
 
Research project title 
Methodology and Design 

심의서식1-1 (version 1.0, 2022.07) 
2 
 
 
 
 
- 
The participant attempts to reach the target using the affected upper limb 
- 
The seated height is adjusted to 100% of the participant’s lower limb length, with the feet flat on the 
floor and the knees bent at a 90 degree angle. A chair with adjustable height is used to achieve this. 
- 
Reaching movements are categorized into three directions: forward, ipsilateral and contralateral direction. 
- 
The task is performed five times in a comfortable speed for each direction, and for analysis purposes, 
three out of the five trials are selected to calculate the average time. 
1. Clinical assessment 
1-1. Fugl-Meyer motor Assessment of the Lower Extremity (FMA-UE) Assessment of 
sensorimotor function: 
 
 

심의서식1-1 (version 1.0, 2022.07) 
3 
 
 
 
 
 
 
 
 

심의서식1-1 (version 2.0, 2022.07) 
4 
 
 
 
 
1-2 TIS 
 

심의서식1-1 (version 2.0, 2022.07) 
5 
 
 
 
 
 

심의서식1-1 (version 2.0, 2022.07) 
6 
 
 
 
 
1-3 PASS 
 
 
 

심의서식1-1 (version 2.0, 2022.07) 
7 
 
 
 
 
Before starting the experiments, the health and physical condition of the subjects are assessed, and within 
24 hours after the experiment, and signs of physical abnormalities are monitored. 
 
 
To determine the sample size, the G * Power V.3.1 was utilized (Franz Paul, Kiel, Germany) (Faul F et al., 
2007) incorporating an effect size of 0.44, α < 0.05, power = 0.80, requiring total sample size of 12 
participants (Dos Santos et al., 2019). 
1. Statistical analysis was performed with IBM SPSS (version 28.0.1.1 (14)). Data were tested for normality 
using the Kolmogorov-Smirnov test. Kinematic data did not significantly deviate from a normal  
2. distribution (P > 0.05). The Chi-square test was used to assess the sex distribution of the participants. 
The independent t-test and Mann-Whitney U test, as a nonparametric test, were employed to 
compare the two groups concerning specific demographic and clinical characteristics. 
 
In the event of an unforeseen emergency, the participant’s condition will be assessed, and immediate contact 
will be made with emergency medical personnel for necessary actions. Subsequently, a prompt report will 
be submitted to the Institutional Review Board (IRB) 
 
 
1. Inability to independently perform the action of sitting and extending the paralyzed arm 
2. Feeling of dizziness 
 
- Prior to the start of the experiment, participants will receive a comprehensive explanation of the entire 
experimental procedure and the potential risks involved through an informed consent document. They will 
proceed with the experiment after understanding and acknowledging these risks. 
- In the event of an emergency during the experiment, participants will be provided with non-monetary 
measures to seek medical examination and treatment from a qualified healthcare institution, even after the 
conclusion of the experiment. 
Safety evaluation criteria and evaluation methods 
Data analysis and statistical methods 
Predicted side effects and precautions with corresponding measures 
Criteria for discontinuation and dropout 
Risks and benefits to research participants 
References 

심의서식1-1 (version 2.0, 2022.07) 
8 
 
 
 
 
Alt Murphy, M., Murphy, S., Persson, H. C., Bergström, U.-B., & Stibrant Sunnerhagen, K. (2018). Analysis 
Using 3D Motion Capture of Drinking Task in People With and Without Upper-extremity Impairments. 
J. Vis. Exp, 133, 57228. https://doi.org/10.3791/57228 
Butcher, S. J., Craven, B. R., Chilibeck, P. D., Spink, K. S., Grona, S. L., & Sprigings, E. J. (2007). The effect 
of trunk stability training on vertical takeoff velocity. Journal of Orthopaedic and Sports Physical Therapy, 
37(5), 223–231. https://doi.org/10.2519/JOSPT.2007.2331 
Che-Nan, H., & Rambely, A. S. (2022). Kinematic Analysis of Daily Activity of Touching Lateral Shoulder 
for Normal Subjects. Applied Sciences (Switzerland), 12(4). https://doi.org/10.3390/APP12042069 
 
Dean (1997) ‘Task-related training improves performance of seated reaching tasks after stroke. A 
randomized controlled trial.’, Stroke, 28(4), pp. 722–8. doi:info:doi/. 
Murphy, M. A., Sunnerhagen, K. S., Johnels, B., & Willén, C. (2006). Three-dimensional kinematic motion 
analysis of a daily activity drinking from a glass: a pilot study. Journal of Neuroengineering and 
Rehabilitation, 3. https://doi.org/10.1186/1743-0003-3-18 
Murphy, M. A., Willén, C., & Sunnerhagen, K. S. (2011). Kinematic variables quantifying upper-extremity 
performance after stroke during reaching and drinking from a glass. Neurorehabilitation and Neural 
Repair, 25(1), 71–80. https://doi.org/10.1177/1545968310370748 
Norton, K. I. (2019). Standards for Anthropometry Assessment. In Kinanthropometry and Exercise 
Physiology (pp. 68–137). Routledge. https://doi.org/10.4324/9781315385662-4 
Thrane, G., Thrane, G., Sunnerhagen, K. S., & Murphy, M. A. (2020). Upper limb kinematics during the 
first year after stroke: The stroke arm longitudinal study at the University of Gothenburg (SALGOT). 
Journal of NeuroEngineering and Rehabilitation, 17(1). https://doi.org/10.1186/s12984-020-00705-2 
Winter, D. A. (2009). Biomechanics and motor control of human movement. Wiley. 
Yang, S. H., Chung, E. J., Lee, J., Lee, S. H., & Lee, B. H. (2021). The effect of trunk stability training based 
on visual feedback on trunk stability, balance, and upper limb function in stroke patients: A randomized 
control trial. Healthcare (Switzerland), 9(5). https://doi.org/10.3390/HEALTHCARE9050532 
Yang, S.-H., Chung, E.-J., Lee, J., Lee, S.-H., Lee, B.-H., & The, B. (2021). The Effect of Trunk Stability 
Training Based on Visual Feedback on Trunk Stability, Balance, and Upper Limb Function in Stroke 
Patients: A Randomized Control Trial Effect of Trunk Stability Training Based on Visual Feedback on Trunk 

심의서식1-1 (version 2.0, 2022.07) 
9 
 
 
 
 
Stability, Balance, and Upper Limb Function in Stroke Patients: A Randomized Control Trial. Healthcare. 
https://doi.org/10.3390/healthcare9050532