Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000623897p
Ethics application status
Not yet submitted
Date submitted
9/04/2020
Date registered
24/05/2021
Date last updated
24/05/2021
Date data sharing statement initially provided
24/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Differences in pointing movement performance between healthy and post stroke adults
Scientific title
Characterization of Upper-extremity movements of healthy and post stroke adults, through Electromyography and Biomechanical Analysis, during the performance of pointing movements
Secondary ID [1] 300974 0
CREE_001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 317009 0
Condition category
Condition code
Stroke 315170 315170 0 0
Haemorrhagic
Stroke 315171 315171 0 0
Ischaemic

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The exposure group will include 20 post stroke adults. This group will perform a pointing task using the more disable upper extremity from a sitting position and with the trunk vertical. The pointing task consists in indicating with the index finger five targets, projected on a panel in front of the participant and equally distributed in a semicircle. The center of the semicircle is aligned to the shoulder of the participant with a radius equal to 80% of arm length. Each of the targets will be pointed five times following the next consecutive steps:
(1) hold the arm in a rest position (forearm resting on the leg) for 1 s.
(2) move the arm at a preferred speed to point the lighted target with the index finger
(3) hold steady pointing the target for 1s
(4) move back the arm to the initial rest position
The start of each step is indicated using sound (ie., beeps). In total, each participant will performed 25 trials (5 targets x 5 times).
Before starting the pointing task, the weight of participants and length of their upper body segments (torso, arm, forearm, hand and clavicle) will be measured. Then, an electromyography surface sensor will be place in the supraspinatus, infraspinatus and teres minor muscles. Finally, 4 small plates containing 3 reflective markers each, will be placed on the participants’ joints (wrist, elbow, shoulder and clavicle).

During the performance of the pointing task, the following measurements will be taken: (i) competition time, (ii) angular and Cartesian variables of joints, such as position, velocity and acceleration, (iii) dynamic variables, such as torques and derived metrics, such as mechanical work and movement smoothness, and (iv) EMG rectified signal of three muscles.
All these measurements will be obtained from the integration and analysis in real time of raw data coming from a tracking camera (Optitrack V120) and a surface electromyography system (Delsys Bagnoli).

Each participant of the Exposure Group will complete the pointing task on a session day, which will be organized chronologically as follows:
(1) Take body weight and length segments measurements
(2) Placement of 4 small plates of reflective markers on participant´s joints
(3) Placement of 3 EMG surface sensors
(4) Performance of the pointing task (n=6)
(5) Removal of the reflective markers and EMG sensors

A short practice period before starting step 4 will be considered and short breaks between the pointing of each target will be allowed. The total duration of the observation session will be approximately of 1 hour and 30 min.
Intervention code [1] 317300 0
Not applicable
Comparator / control treatment
The Comparison group will include 20 healthy adults matched for age and gender with the post stroke adults of the exposure group. This group will perform the same pointing task than exposure group.

In the same way as in the Exposure Group, the total weight and length of their body segments (torso, arm, forearm, hand and clavicle) of participants will be measured. Furthermore, EMG sensors and reflective markers will be placed on participants´ muscles and joints, respectively.

The same measurements taken in the Exposure group will be taken in the Comparison Group: (i) competition time of the task, (ii) angular and cartesian variables of joints, such as position, velocity and acceleration, (iii) dynamic variables, such as torques and derived metrics, such as mechanical work and movement smoothness, and (iv) EMG rectified signal of three muscles.

Each participant of the Comparison Group will complete all the procedure on a single session, which will consists of the following steps (organized chronologically):
(1) Take body weight and length segments measurements
(2) Placement of 4 small plates of reflective markers on participant´s joints
(3) Placement of 3 EMG surface sensors
(4) Performance of the pointing task (n=6)
(5) Removal of the reflective markers and EMG sensors

A short practice period before starting step 4 will be considered and short breaks between the pointing of each target will be allowed. The total duration of the observation session will be approximately of 1 hour and 10 min.
Control group
Active

Outcomes
Primary outcome [1] 323431 0
Joint movement smoothness, estimated through a motion tracking camera in combination with a simplified human biomechanical model
Timepoint [1] 323431 0
Immediately after pointing a target five times (primary endpoint)
Primary outcome [2] 323432 0
EMG rectified signal will be used to assess muscular activity of three muscles: biceps, deltoid and trapezius
Timepoint [2] 323432 0
Immediately after pointing a target five times (primary endpoint)
Secondary outcome [1] 381923 0
Energy expenditure to perform the sit-to-stand task, estimated through a motion tracking camera in combination with a simplified human biomechanical model
Timepoint [1] 381923 0
Immediately after pointing a target five times
Secondary outcome [2] 381924 0
Mean angular variables of human joints (position, velocity and acceleration), estimated through a motion tracking camera in combination with a simplified human biomechanical model
Timepoint [2] 381924 0
Immediately after pointing a target five times
Secondary outcome [3] 381925 0
Mean cartesian variables of human joints (position, velocity and acceleration), estimated through a motion tracking camera in combination with a simplified human biomechanical model
Timepoint [3] 381925 0
Immediately after pointing a target five times
Secondary outcome [4] 381926 0
Mean rotational forces (torques) at human joints, estimated through a motion tracking camera in combination with a simplified human biomechanical model
Timepoint [4] 381926 0
Immediately after pointing a target five times

Eligibility
Key inclusion criteria
- Be a patient at the CREE (Center for Rehabilitation and Special Education) in Saltillo
-With a medical diagnosis of stroke
-With a GMFC between I and III
- Ability to understand and follow instructions
-Submit the "Informed Consent" signed before the study
Minimum age
45 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Ingestion of some type of drug or controlled medication

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
To discard the established null hypotheses, the statistical F value for each of the independent variables will be calculated. This will be done through an analysis of variance in the phase factor. Subsequently, and only when the result is significant, a multiple comparison test will be carried out. In all the analyzes a level of significance of p <0.5 would be considered. The software to be used will be R.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 22480 0
Mexico
State/province [1] 22480 0
Coahuila

Funding & Sponsors
Funding source category [1] 305421 0
Government body
Name [1] 305421 0
Consejo Nacional de Ciencia y Tecnología
Country [1] 305421 0
Mexico
Primary sponsor type
Hospital
Name
Centro de Rehabilitación y Educación Especial
Address
Prolongación Martín Enríque 382, Sin Nombre de Colonia 16, Saltillo, Coahuila
Country
Mexico
Secondary sponsor category [1] 305812 0
University
Name [1] 305812 0
Centro de Investigación y Estudios Avanzados de Mexico
Address [1] 305812 0
Av. Industrial Metalurgia #1062, Parque Ind. Ramos Arizpe, Ramos Arizpe, Coah. C.P. 25900, México
Country [1] 305812 0
Mexico

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 305742 0
Ethics Committee (EC) of the Center for Rehabilitation and Special Education (CREE)
Ethics committee address [1] 305742 0
Ethics committee country [1] 305742 0
Mexico
Date submitted for ethics approval [1] 305742 0
15/06/2021
Approval date [1] 305742 0
Ethics approval number [1] 305742 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101430 0
Prof Nadia Vanessa Garcia Hernandez
Address 101430 0
PhD Nadia Vanessa García Hernández (Principal Investigator ), Center for research and advanced studies of Mexico, Av. Industrial Metalurgia #1062, Parque Ind. Ramos Arizpe, Ramos Arizpe, Coah. C.P. 25900, México
Country 101430 0
Mexico
Phone 101430 0
+5284443896008
Fax 101430 0
Email 101430 0
[email protected]
Contact person for public queries
Name 101431 0
Nadia Vanessa Garcia Hernandez
Address 101431 0
PhD Nadia Vanessa García Hernández, Center for research and advanced studies of Mexico, Av. Industrial Metalurgia #1062, Parque Ind. Ramos Arizpe, Ramos Arizpe, Coah. C.P. 25900, México
Country 101431 0
Mexico
Phone 101431 0
+5284443896008
Fax 101431 0
Email 101431 0
[email protected]
Contact person for scientific queries
Name 101432 0
Nadia Vanessa Garcia Hernandez
Address 101432 0
PhD Nadia Vanessa García Hernández, Center for research and advanced studies of Mexico, Av. Industrial Metalurgia #1062, Parque Ind. Ramos Arizpe, Ramos Arizpe, Coah. C.P. 25900, México
Country 101432 0
Mexico
Phone 101432 0
+5284443896008
Fax 101432 0
Email 101432 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.