- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05683158
Compensatory Kinematic Movements in Various Directions After Stroke
Compensatory Kinematic Movement for Reaching Task in Various Directions in After Stroke
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ulju
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Ulsan, Ulju, Korea, Republic of, 44919
- Ulsan National Institute of Science and Technology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
The inclusion criteria used in the randomized controlled trials were as follows:
Stroke
- Subject consisted of the physician's confirmation of chronic hemiplegia
- onset ≥ 6 months
- Mini-mental state examination≥25
- Biceps ≤2, Triceps≤2
- Ability to Sit on a chair alone
- FMA upper extremity score ≥ 21 points, FMA upper extremity ≤ 66 points
Healthy
- Age of matching the stroke group
- Absence of neurological disease and orthopedic disease
Exclusion Criteria:
Stroke
- Biceps>2, Triceps>2
- Flaccid
- Neglect syndrome
- Have neurological disease and orthopedic disease
- Lack of coordination
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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chronic stroke
The subject consisted of the physician's confirmation of chronic hemiplegia onset ≥ 6 months Mini-mental state examination≥25 Biceps ≤2, Triceps≤2 Ability to Sit on a chair alone FMA upper extremity score ≥ 21points, FMA upper extremity score ≤ 66 points The symptom is mild or moderate level (MAS≤2) and can sit alone.
The subject reaches to target by affected arm in 3 directions(medial_45, forward_90 and lateral_135 degrees)
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Healthy
Matching aged people, not having neurological system or orthopedic disease on Upper extremity. The subject reaches to target by non-dominant arm in 3 directions(medial_45, forward_90 and lateral_135 degrees) |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Differences in Spatial Measurements of Trunk Dislocation Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients
Time Frame: 1 time (Baseline)
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Trunk dislocation (reaching phase in millimetre; mm) in reaching task.
The measurements are detected in 3 directions (Forward_90, Lateral_135, Medial_45 degree).
Participants reach to a bell as quickly as possible.
3rd joint is calculated for quantitative measurements.
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1 time (Baseline)
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Differences in Spatial Measurements of Elbow and Shoulder Angle Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients
Time Frame: 1 time (Baseline)
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Elbow extension and shoulder flexion angle (degree) in reaching task.
The measurements are detected in 3 directions (Forward_90, Lateral_135, Medial_45 degree).
Participants reach to a bell as quickly as possible.
3rd joint is calculated for quantitative measurements.
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1 time (Baseline)
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Differences in Temporal Measurements of Movement Unit Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients
Time Frame: 1 time (Baseline)
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Movement units are quantified by counting velocity peaks during the reaching task.
A movement unit is defined as a velocity profile segment between a local minimum and the following maximum velocity that exceeds 20 mm/s, with a minimum time interval of 150 ms between subsequent peaks.
This measure represents the smoothness of movement, where fewer movement units indicate smoother motion The measurements are detected in 3 directions (Forward_90, Lateral_135, Medial_45 degree).
Participants reach to a bell as quickly as possible.
3rd joint is calculated for quantitative measurements.
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1 time (Baseline)
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Differences in Temporal Measurements of Hand Movement Time Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients
Time Frame: 1 time (Baseline)
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The period from hand tangential velocity movement onset to offset was the total time (entire time of reach and return phase [second]). The period when the tangential velocity exceeded 10% of its peak was termed hand movement onset, whereas that when the tangential velocity stayed below 10% of its peak was termed hand movement offset. The measurements are detected in 3 directions (Forward_90, Lateral_135, Medial_45 degree). Participants reach to a bell as quickly as possible. 3rd joint is calculated for quantitative measurements. |
1 time (Baseline)
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Differences in Temporal Measurements of Hand Velocity Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients
Time Frame: 1 time (Baseline)
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Tangential velocity was computed for the hand marker's velocity.
Peak elbow angular velocity (rad/s) during elbow extension were measured The measurements are detected in 3 directions (Forward_90, Lateral_135, Medial_45 degree).
Participants reach to a bell as quickly as possible.
3rd joint is calculated for quantitative measurements.
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1 time (Baseline)
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Differences in Temporal Measurements of Elbow Extension Acceleration Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients
Time Frame: 1 time (Baseline)
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Acceleration (rad/s2) during elbow extension was measured The measurements are detected in 3 directions (Forward_90, Lateral_135, Medial_45 degree).
Participants reach to a bell as quickly as possible.
3rd joint is calculated for quantitative measurements.
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1 time (Baseline)
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Difference of the Components Temporal Measurements Between Healthy and Stroke
Time Frame: 1 time (Baseline)
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Tangential velocity was computed for the hand marker's velocity. The period when the tangential velocity exceeded 10% of its peak was termed hand movement onset, whereas that when the tangential velocity stayed below 10% of its peak was termed hand movement offset. Peak hand velocity (mm/s) was analyzed. The measurements are detected in 3 directions (Forward_90, Lateral_135, Medial_45 degree). Participants reach to a bell as quickly as possible. 3rd joint is calculated for quantitative measurements. |
1 time (Baseline)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Comparison of Fugl-Meyer Assessment Scores Between Chronic Stroke Patients and Healthy
Time Frame: Baseline
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Related Fugl-Meyer Assessment score(dependent) to predictors(independent) in three directions. In sitting position, the sum of each subtotal score is 66 (maximum) and the minimum is 0. Subscales were summed to compute a total score. Cutoff scores defined 0~20: severe, 21 ~ 50: moderate, 51~66: mild 1) Reflex activity_max 4 score, 2) Volitional movement within synergies_ max 18, 3) Volitional movement mixing synergies_ max 6, 4) Volitional movement with little or no synergy_ max 6, 5) Normal reflex activity_max 2, 6) Wrist movement_ max 10, 7) Hand movement with grasp_ max 14, 8) coordination/speed_max 6. |
Baseline
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Comparison of Modified Ashworth Scale Between Chronic Stroke Patients and Healthy Controls
Time Frame: Baseline
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Scoring for Biceps
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Baseline
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Range of motion_Health Status Chronic Stroke
Time Frame: Baseline
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Shoulder and elbow joint range of motion
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Baseline
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Trunk Impairment Scale(TIS)_Health Status Chronic Stroke
Time Frame: 1 time(Baseline)
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The Trunk Impairment Scale (TIS) for stroke has a total score of 23 points, with higher scores indicating better trunk control ability. TIS components: Static sitting balance - 7 points Dynamic sitting balance - 10 points Coordination - 6 points 23 points = Optimal trunk control ability (normal performance of all items) 0 points = Minimal trunk control ability (unable to perform) Static sitting balance Dynamic sitting balance Co-ordination |
1 time(Baseline)
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Postural Assessment Scale for Stroke(PASS)_Health Status Chronic Stroke
Time Frame: Baseline
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The Postural Assessment Scale for Stroke (PASS) evaluates postural control in stroke patients, with scores ranging from 0-36 points, where higher scores indicate better functional recovery. 1) Sitting without support 2,3) Standing with(without) support 4,5) Standing on (non)paretic leg 6) Supine to affected side lateral 7) Supine to non-affected side lateral 8) Supine to sitting up on the edge of the table 9) Sitting on the edge of the table to supine 10) Sitting to standing up 11) Standing up to sitting down 12) Standing, picking up a pencil from the floor |
Baseline
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Fugl_Meyer Assessment(FMA)_Health Status Chronic Stroke
Time Frame: Baseline
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Upper extremity The total score means that severe <20, 20=<moderate<60, 60=<mild. Higher scores on the Fugl-Meyer Assessment indicate better upper limb motor control with reduced synergistic patterns, while lower scores indicate stronger synergistic patterns due to spasticity 1) Reflex activity_max 4 score, 2) Volitional movement within synergies_ max 18, 3) Volitional movement mixing synergies_ max 6, 4) Volitional movement with little or no synergy_ max 6, 5) Normal reflex activity_max 2, 6) Wrist movement_ max 10, 7) Hand movement with grasp_ max 14, 8) coordination/speed_max 6.
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Baseline
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Modified Ashworth Scale_Stiffness of Chronic Stroke
Time Frame: Baseline
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Scoring for Triceps
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Baseline
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jóse Casaña Granell, PhD, University of Valencia
- Principal Investigator: Joaquin Calatayud Villalba, PhD, University of Valencia
- Principal Investigator: Sang Hoon Kang, PhD, Ulsan National Institute of Science and Technology
Publications and helpful links
General Publications
- Cirstea MC, Levin MF. Compensatory strategies for reaching in stroke. Brain. 2000 May;123 ( Pt 5):940-53. doi: 10.1093/brain/123.5.940.
- Wu CY, Liing RJ, Chen HC, Chen CL, Lin KC. Arm and trunk movement kinematics during seated reaching within and beyond arm's length in people with stroke: a validity study. Phys Ther. 2014 Jun;94(6):845-56. doi: 10.2522/ptj.20130101. Epub 2014 Jan 30.
- Hsieh YW, Liing RJ, Lin KC, Wu CY, Liou TH, Lin JC, Hung JW. Sequencing bilateral robot-assisted arm therapy and constraint-induced therapy improves reach to press and trunk kinematics in patients with stroke. J Neuroeng Rehabil. 2016 Mar 22;13:31. doi: 10.1186/s12984-016-0138-5.
- Adamovich SV, Archambault PS, Ghafouri M, Levin MF, Poizner H, Feldman AG. Hand trajectory invariance in reaching movements involving the trunk. Exp Brain Res. 2001 Jun;138(3):288-303. doi: 10.1007/s002210100694.
- Alt Murphy M, Murphy S, Persson HC, Bergstrom UB, Sunnerhagen KS. Kinematic Analysis Using 3D Motion Capture of Drinking Task in People With and Without Upper-extremity Impairments. J Vis Exp. 2018 Mar 28;(133):57228. doi: 10.3791/57228.
- Machado LR, Heathcock J, Carvalho RP, Pereira ND, Tudella E. Kinematic characteristics of arm and trunk when drinking from a glass in children with and without cerebral palsy. Clin Biomech (Bristol). 2019 Mar;63:201-206. doi: 10.1016/j.clinbiomech.2019.03.011. Epub 2019 Mar 19.
- Lobo-Prat J, Font-Llagunes JM, Gomez-Perez C, Medina-Casanovas J, Angulo-Barroso RM. New biomechanical model for clinical evaluation of the upper extremity motion in subjects with neurological disorders: an application case. Comput Methods Biomech Biomed Engin. 2014 Aug;17(10):1144-56. doi: 10.1080/10255842.2012.738199. Epub 2012 Nov 27.
- Levin MF, Michaelsen SM, Cirstea CM, Roby-Brami A. Use of the trunk for reaching targets placed within and beyond the reach in adult hemiparesis. Exp Brain Res. 2002 Mar;143(2):171-80. doi: 10.1007/s00221-001-0976-6. Epub 2002 Jan 8.
- Dean CM, Shepherd RB. Task-related training improves performance of seated reaching tasks after stroke. A randomized controlled trial. Stroke. 1997 Apr;28(4):722-8. doi: 10.1161/01.str.28.4.722.
- Dean C, Shepherd R, Adams R. Sitting balance I: trunk-arm coordination and the contribution of the lower limbs during self-paced reaching in sitting. Gait Posture. 1999 Oct;10(2):135-46. doi: 10.1016/s0966-6362(99)00026-0.
- Thrane G, Sunnerhagen KS, Murphy MA. Upper limb kinematics during the first year after stroke: the stroke arm longitudinal study at the University of Gothenburg (SALGOT). J Neuroeng Rehabil. 2020 Jun 15;17(1):76. doi: 10.1186/s12984-020-00705-2.
- Cirstea MC, Mitnitski AB, Feldman AG, Levin MF. Interjoint coordination dynamics during reaching in stroke. Exp Brain Res. 2003 Aug;151(3):289-300. doi: 10.1007/s00221-003-1438-0. Epub 2003 Jun 19.
- Schwarz A, Veerbeek JM, Held JPO, Buurke JH, Luft AR. Measures of Interjoint Coordination Post-stroke Across Different Upper Limb Movement Tasks. Front Bioeng Biotechnol. 2021 Jan 28;8:620805. doi: 10.3389/fbioe.2020.620805. eCollection 2020.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Kinematic movements of stroke
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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