Upper Extremity ParesisNCT03655327
Reach to Grasp Movement of Stroke Patients: Different Heights and Weights
An observational study of Upper Extremity Paresis and Motor Control, run by Ben-Gurion University of the Negev at 1 site in Israel.
Trial summary
A cross-sectional study of Reach-to-Grasp (RTG) movement of the upper limb of stroke patients vs. healthy controls. 30 stroke patients and 30 healthy controls will take place in a cross-sectional study. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Extremity Paresis, Motor Control
- What is being tested?
- reach to grasp a cup
- How many people
- 46 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Aug 2017to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: group 1: stroke patients with upper limb paresis group 2: healthy controls
Who may be able to join
- First unilateral (ischemic or hemorrhagic) stroke with diagnosis confirmed by imaging from hospital discharge records.
- Age 30-85 years.
- Mini-Mental State Examination score ≥ 24/30.
- Fugl-Meyer Upper Extremity score 16-66.
- Pain level ≤ 4 on a 10-point Visual Analogue Scale.
- Upper limb muscle tone assessed by Modified Ashworth Scale ≤ 2
- Brunnstrom stages of motor recovery ≥ 3/7
- Ability to sit independently without external support.
Who cannot join
- Additional neurological problems (such us Parkinson's disease, unilateral neglect, pusher syndrome and apraxia).
- Musculoskeletal, vision or sensory deficits affecting upper limb movements.
- Aphasia affecting understanding of simple instructions.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Upper Limb Joints Position During Reach and Grasp Functions in Different Heights and Weights in Sub-acute Stroke Patients
A cross-sectional study of Reach-to-Grasp (RTG) movement of the upper limb of stroke patients vs. healthy controls. 30 stroke patients and 30 healthy controls will take place in a cross-sectional study. 3D kinematics and force regulation measures of RTG to a full and an empty cup at three different table heights will be measured. Motion analysis will include joint position and inter-limb coordination, velocity, and smoothness of movement. Data collected from the force sensor embaded in the cup will include peak force, time to peak force and variability in force production.
Read the detailed description
Introduction Up to 75% of stroke survivors suffer persistent UL sensorimotor impairments, which considerably affect their ability to reach, pick up, and hold on to objects. Such deficits dramatically reduce the independence and, consequently, the quality of life, of post-stroke patients, and means for improving the effectiveness of post-stroke UL rehabilitation are much sought after. A prominent post-stoke UL impairment, which is strongly correlated with the level of the general post-stoke impairment and considerably affects daily activities and independence, is an impairment in reach-to-grasp (RTG) movements. Specifically, following stroke, movements become less smooth, less accurate, and less efficient than those of healthy individuals. As a result of such impairments, compensatory movements emerge, whereby the movement goal is achieved using an abnormal muscle activation pattern-e.g., excessive trunk displacement and a frontal hand orientation for grasping-which can lead to pain and fatigue. Retraining the coordination of RTG movements is, therefore, a major goal of post-stroke rehabilitation.
Despite extensive studies of post-stroke RTG movements, information is limited on how the height and weight of objects affect the ability of the impaired UL to reach and hold on to these objects - two crucial abilities for performing daily activities. Previous studies have shown that the height of the target object affects post-stroke RTG movements-namely, when post-stroke patients reach to higher targets, they recruit excessive compensatory muscles in the impaired UL, take longer to reach the target, demonstrate increased endpoint error, shoulder flexion, and abduction range of motion, and activate different muscle patterns to stabilize their trunks-highlighting the need to consider the height of target objects when formulating intervention programs to improve post-stroke RTG movements. However, most available studies of post-stroke UL RTG movements employed virtual tasks, which cannot accurately represent the physical world; It has been shown that, in both in stroke survivors and healthy individuals, an RTG task in a virtual 2D environment is slower, shorter, less straight, less accurate, and involves smaller ranges of shoulder and elbow joint excursions than an RTG task in a real, physical environment. These findings and others stress the importance of using real, daily objects of different heights to characterize and treat post-stroke UL RTG movement impairments. In addition, moving the arm while holding an object requires the individual to (unconsciously) increase the grip force to prevent the object from sliding, which may be impaired in post-stroke patients. However, clinical practitioners typically employ designated tools to measure grip forces after stroke-e.g., a dynamometer or a Pinch,-Grip,-Lift-and-Hold apparatus-rather than daily objects. The investigators are not familiar with studies that test lifting everyday objects of different weights following a stroke. Therefore, the first aim of the proposed study is to characterize the RTG movements and the grasp forces of post-stroke patients, as compared with those of healthy control individuals, attempting to reach, grasp, and lift real, functional, daily objects placed at different heights and of different weights.
Aim: to identify key differences between the RTG movements of post-stroke patients and healthy controls toward real objects of different weights and placed at different heights.
Comprehensively characterize the quality and efficacy of task-oriented RTG movements of sub-acute post-stroke patients and of healthy individuals to real, functional objects of different weights, placed at different heights (vertical distance from the participant), using a motion-capture system and a force sensor. Each participant repeats a RTG movement 18 times, 3 times each height and condition of cup (empty or full).
A total of 60 participants will take part in this study. Thirty hospitalized post-stroke patients will be recruited from the inpatient population of "Bet Hadar" geriatric rehabilitation center. In addition, thirty age-matched healthy control participans will be recruited from the community.
Procedure All participants will be examined individually by a single physical therapist (a master's student), in two 1-hour sessions. Evaluation of the control group will be performed in one session, lasting approximately 45 minutes. Stroke patients will be examined between one to two weeks before their discharge date from the rehabilitation center (average duration of rehabilitation in the hospital is two to three months). Stroke patients' measurement will be conducted in two separate days, in order to avoid fatigue, as it comprises both kinematic measurements and clinical mesurements.
The measurement session will be performed while the participants are in a sitting position, without back support, in front of a height-adjustable table. Participants will be instructed, once they hear a "beep" sound, to reach their hand at a self-selected speed, forward, toward a cup located on the table, lift it and place it on top of a five-centimeters-high block, positioned nearby. The participants will be instructed at the beginning of the session to avoid bending the trunk as much as possible during the reach movement, but no restraint of the trunk will be applied. The reach will be performed at three different heights: (a) low height- the height of the wrist when the hand is extended downwards, (b) medium height, ~75 cm from the floor, the height of a standard table and (c) high height- the height of the shoulder. The cup will be placed at an arm's distance, measured from the latral acromion to the radial styloid process, to avoid excessive trunk movement during the reach movement. This task was chosen as this is a functional everyday task.
In order to emphasize the everyday functionality of the task, in addition to the height variability, reach and grasp movements will be executed using a cup of two different weights: an empty cup and a cup full with water (250 ml). Participants will be informed whether the cup is full or empty. Lifting a cup primarily requires movement of the arm rather than the fingers. Hence, the role of the grasp is to stabilize the object and prevent undesirable movement. The reach will be executed by the affected arm of the post-stroke patients. Since the affected arm can be either their dominant or their non-dominant arm, the control group will be matched for dominance. That is, if half the patient group will reach with their non-dominant arm, then half of the control group will also be asked to reach with their non-dominant arm. Starting position for the low height will be with the arm held verticaly at the side of the body. Starting position for the medium and high heights will be with the arm placed on the ipsilateral thigh with palm facing down. Every reach combination of height and weight will be evaluated three times, according to the participant's ability. That is, while the maximal total number of reaching trials will be 18, some participants may not be able to complete all trials, due to arm weakness, fatigue, pain, etc. The order of the heights and weights will be set randomly using a computer program to prevent the influence of fatigue on one of the heights or weights.
Equipment Motion capture system: Position of the upper extremity joints during reach movements will be recorded by a motion capture system V120:Trio (OptiTrack, NaturalPoint, Inc., OR, USA) using eleven reflective markers placed on the participants' upper body. The V120:Trio tracking system is a portable multiple-camera, 6DoF optical object tracking technology. No calibration of the Trio system is required. Markers will be placed as follows: two markers will be placed vertically alligned on the sternum, to reflect the trunk motion, and one marker will be placed on each of the following anatomical landmarks: the lateral portion of the acromion-reflect the scapular motion, the proximal humerus, the lateral epicondyle of the elbow, the middle forearm, radial and ulnar styloid processes, the dorsal side of the palm at the axis along the middle part of the third metacarpal bone - to reflect the wrist motion, the index finger and the thumb. Additional two stationary vertical markers will be placed on the wall as reference points, and three additional markers will be placed on the cup and defined by the system as a rigid body. Data sampling speed of the Trio system is 120 Hz.
Force Sensor: Grip forces will be measured with a 3D force sensor (Nano25-E Transducer, ATI Industrial Automation, INC) embedded in the custom-built 3d-printed cup (see figure 3 in Appendix 1). The data sample speed of the force sensor is 100 Hz. Calibration of the sensor force is needed prior to every measurement trial (each reach movement). The data collected from the force sensor is the summed grip force applied on the cup.
- Conditions
- Upper Extremity Paresis, Motor Control
- Being tested
- reach to grasp a cup
- Keywords
- stroke rehabilitation
- Medical subject headings
- Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reach to grasp a cupOther
reach to grasp a cup of different weights located at different heights of table
| Study group | Role | What they receive |
|---|---|---|
| stroke patients | stroke patients with upper limb paresis Receives: Other: reach to grasp a cup | |
| healthy control group | healthy participants with no motor disability of the upper limb Receives: Other: reach to grasp a cup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Index of curvature
the ratio between a straight line and the path of the movement the participant did
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start1 Aug 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Extremity ParesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ben-Gurion University of the Negev
- Sponsor type
- University, hospital or other
- Collaborators
- Barzilai Medical Center, Bet Hadar
- Responsible party
- Principal investigator, Shelly Levy-Tzedek, Ben-Gurion University of the Negev
- Investigators
- Ron Milo, MD, Principal investigator, Barzilai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03655327
- Sponsor's protocol ID
- 0014-17-BRZ
- Status last verified
- Jul 2019
- First submitted
- 30 Aug 2018
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: not yet decided. will be decided after data analysis
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Upper Limb Joints Position During Reach and Grasp Functions in Different Heights and Weights in Sub-acute Stroke Patients
- ClinicalTrials.gov ID
- NCT03655327
- Acronym / sponsor ID
- 0014-17-BRZ
- Conditions
- Upper Extremity Paresis, Motor Control
- Keywords
- stroke rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Ben-Gurion University of the NegevUniversity, hospital or other
- Collaborators
- Barzilai Medical Center, Bet Hadar
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A cross-sectional study of Reach-to-Grasp (RTG) movement of the upper limb of stroke patients vs. healthy controls. 30 stroke patients and 30 healthy controls will take place in a cross-sectional study. 3D kinematics and force regulation measures of RTG to a full and an empty cup at three different table heights will be measured. Motion analysis will include joint position and inter-limb coordination, velocity, and smoothness of movement. Data collected from the force sensor embaded in the cup will include peak force, time to peak force and variability in force production.
Detailed description
Introduction Up to 75% of stroke survivors suffer persistent UL sensorimotor impairments, which considerably affect their ability to reach, pick up, and hold on to objects. Such deficits dramatically reduce the independence and, consequently, the quality of life, of post-stroke patients, and means for improving the effectiveness of post-stroke UL rehabilitation are much sought after. A prominent post-stoke UL impairment, which is strongly correlated with the level of the general post-stoke impairment and considerably affects daily activities and independence, is an impairment in reach-to-grasp (RTG) movements. Specifically, following stroke, movements become less smooth, less accurate, and less efficient than those of healthy individuals. As a result of such impairments, compensatory movements emerge, whereby the movement goal is achieved using an abnormal muscle activation pattern-e.g., excessive trunk displacement and a frontal hand orientation for grasping-which can lead to pain and fatigue. Retraining the coordination of RTG movements is, therefore, a major goal of post-stroke rehabilitation.
Despite extensive studies of post-stroke RTG movements, information is limited on how the height and weight of objects affect the ability of the impaired UL to reach and hold on to these objects - two crucial abilities for performing daily activities. Previous studies have shown that the height of the target object affects post-stroke RTG movements-namely, when post-stroke patients reach to higher targets, they recruit excessive compensatory muscles in the impaired UL, take longer to reach the target, demonstrate increased endpoint error, shoulder flexion, and abduction range of motion, and activate different muscle patterns to stabilize their trunks-highlighting the need to consider the height of target objects when formulating intervention programs to improve post-stroke RTG movements. However, most available studies of post-stroke UL RTG movements employed virtual tasks, which cannot accurately represent the physical world; It has been shown that, in both in stroke survivors and healthy individuals, an RTG task in a virtual 2D environment is slower, shorter, less straight, less accurate, and involves smaller ranges of shoulder and elbow joint excursions than an RTG task in a real, physical environment. These findings and others stress the importance of using real, daily objects of different heights to characterize and treat post-stroke UL RTG movement impairments. In addition, moving the arm while holding an object requires the individual to (unconsciously) increase the grip force to prevent the object from sliding, which may be impaired in post-stroke patients. However, clinical practitioners typically employ designated tools to measure grip forces after stroke-e.g., a dynamometer or a Pinch,-Grip,-Lift-and-Hold apparatus-rather than daily objects. The investigators are not familiar with studies that test lifting everyday objects of different weights following a stroke. Therefore, the first aim of the proposed study is to characterize the RTG movements and the grasp forces of post-stroke patients, as compared with those of healthy control individuals, attempting to reach, grasp, and lift real, functional, daily objects placed at different heights and of different weights.
Aim: to identify key differences between the RTG movements of post-stroke patients and healthy controls toward real objects of different weights and placed at different heights.
Comprehensively characterize the quality and efficacy of task-oriented RTG movements of sub-acute post-stroke patients and of healthy individuals to real, functional objects of different weights, placed at different heights (vertical distance from the participant), using a motion-capture system and a force sensor. Each participant repeats a RTG movement 18 times, 3 times each height and condition of cup (empty or full).
A total of 60 participants will take part in this study. Thirty hospitalized post-stroke patients will be recruited from the inpatient population of "Bet Hadar" geriatric rehabilitation center. In addition, thirty age-matched healthy control participans will be recruited from the community.
Procedure All participants will be examined individually by a single physical therapist (a master's student), in two 1-hour sessions. Evaluation of the control group will be performed in one session, lasting approximately 45 minutes. Stroke patients will be examined between one to two weeks before their discharge date from the rehabilitation center (average duration of rehabilitation in the hospital is two to three months). Stroke patients' measurement will be conducted in two separate days, in order to avoid fatigue, as it comprises both kinematic measurements and clinical mesurements.
The measurement session will be performed while the participants are in a sitting position, without back support, in front of a height-adjustable table. Participants will be instructed, once they hear a "beep" sound, to reach their hand at a self-selected speed, forward, toward a cup located on the table, lift it and place it on top of a five-centimeters-high block, positioned nearby. The participants will be instructed at the beginning of the session to avoid bending the trunk as much as possible during the reach movement, but no restraint of the trunk will be applied. The reach will be performed at three different heights: (a) low height- the height of the wrist when the hand is extended downwards, (b) medium height, ~75 cm from the floor, the height of a standard table and (c) high height- the height of the shoulder. The cup will be placed at an arm's distance, measured from the latral acromion to the radial styloid process, to avoid excessive trunk movement during the reach movement. This task was chosen as this is a functional everyday task.
In order to emphasize the everyday functionality of the task, in addition to the height variability, reach and grasp movements will be executed using a cup of two different weights: an empty cup and a cup full with water (250 ml). Participants will be informed whether the cup is full or empty. Lifting a cup primarily requires movement of the arm rather than the fingers. Hence, the role of the grasp is to stabilize the object and prevent undesirable movement. The reach will be executed by the affected arm of the post-stroke patients. Since the affected arm can be either their dominant or their non-dominant arm, the control group will be matched for dominance. That is, if half the patient group will reach with their non-dominant arm, then half of the control group will also be asked to reach with their non-dominant arm. Starting position for the low height will be with the arm held verticaly at the side of the body. Starting position for the medium and high heights will be with the arm placed on the ipsilateral thigh with palm facing down. Every reach combination of height and weight will be evaluated three times, according to the participant's ability. That is, while the maximal total number of reaching trials will be 18, some participants may not be able to complete all trials, due to arm weakness, fatigue, pain, etc. The order of the heights and weights will be set randomly using a computer program to prevent the influence of fatigue on one of the heights or weights.
Equipment Motion capture system: Position of the upper extremity joints during reach movements will be recorded by a motion capture system V120:Trio (OptiTrack, NaturalPoint, Inc., OR, USA) using eleven reflective markers placed on the participants' upper body. The V120:Trio tracking system is a portable multiple-camera, 6DoF optical object tracking technology. No calibration of the Trio system is required. Markers will be placed as follows: two markers will be placed vertically alligned on the sternum, to reflect the trunk motion, and one marker will be placed on each of the following anatomical landmarks: the lateral portion of the acromion-reflect the scapular motion, the proximal humerus, the lateral epicondyle of the elbow, the middle forearm, radial and ulnar styloid processes, the dorsal side of the palm at the axis along the middle part of the third metacarpal bone - to reflect the wrist motion, the index finger and the thumb. Additional two stationary vertical markers will be placed on the wall as reference points, and three additional markers will be placed on the cup and defined by the system as a rigid body. Data sampling speed of the Trio system is 120 Hz.
Force Sensor: Grip forces will be measured with a 3D force sensor (Nano25-E Transducer, ATI Industrial Automation, INC) embedded in the custom-built 3d-printed cup (see figure 3 in Appendix 1). The data sample speed of the force sensor is 100 Hz. Calibration of the sensor force is needed prior to every measurement trial (each reach movement). The data collected from the force sensor is the summed grip force applied on the cup.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stroke patients | – | Other: reach to grasp a cupstroke patients with upper limb paresis |
| healthy control group | – | Other: reach to grasp a cuphealthy participants with no motor disability of the upper limb |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- group 1: stroke patients with upper limb paresis group 2: healthy controls
Key inclusion criteria (8 listed)
- First unilateral (ischemic or hemorrhagic) stroke with diagnosis confirmed by imaging from hospital discharge records.
- Age 30-85 years.
- Mini-Mental State Examination score ≥ 24/30.
- Fugl-Meyer Upper Extremity score 16-66.
- Pain level ≤ 4 on a 10-point Visual Analogue Scale.
Key exclusion criteria (4 listed)
- Additional neurological problems (such us Parkinson's disease, unilateral neglect, pusher syndrome and apraxia).
- Musculoskeletal, vision or sensory deficits affecting upper limb movements.
- Aphasia affecting understanding of simple instructions.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reach to grasp a cupreach to grasp a cup of different weights located at different heights of table | Other | healthy control group, stroke patients |
Primary outcome
Index of curvature
Time frame: 30 minutes
the ratio between a straight line and the path of the movement the participant did
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
- Individual participant dataSharing planned: Undecided. not yet decided. will be decided after data analysis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ron Milo, MD principal investigator
Barzilai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Extremity Paresis and Motor Control, run by Ben-Gurion University of the Negev at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Index of curvature (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2019; AzTrials last refreshed its copy on 7 Nov 2026.