- 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 (Estimated)
Contacts and Locations
Study Contact
- Name: Ae Non Lee, Master
- Phone Number: +811075442844
- Email: aenon@alumni.uv.es
Study Locations
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-
Ulju
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Ulsan, Ulju, Korea, Republic of, 44919
- Recruiting
- Ulsan National Institute of Science and Technology
-
Contact:
- HYEKYUNG HEO, Bachelor
- Phone Number: +821085801981
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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 |
---|
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)
|
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 |
---|---|---|
Difference of the components temporal measurements between healthy and stroke
Time Frame: 1 time(Baseline)
|
Hand velocity(peak velocity of 3th metacarpal phalangeal joint marker in reaching phase in millimetres per second; mm/s),total movement time in second, reaching time in second, number of movement units. elbow angular acceleration(elbow angular velocity per unit time; rad/sec2) and elbow angular velocity(time rate at which an object rotates, or revolves, about an axis, or at which the angular displacement between two forearm and humerus; rad/s) in reaching 3 directions(medial_45, forward_90 and lateral_135 degrees). Participants reach to a bell as quickly as possible. 3th joint is calculated for quantitative measurements. |
1 time(Baseline)
|
Difference of the components spatial measurements between healthy and stroke
Time Frame: 1 time(Baseline)
|
Trunk dislocation of reaching phase in millimetre; mm), elbow and shoulder angle in reaching in degree. The measurements are detected by 3 directions(medial_45, forward_90 and lateral_135 degrees). Participants reach to a bell as quickly as possible. 3th joint is calculated for quantitative measurements. |
1 time(Baseline)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relationship between clinical score and kinematic variable in each direction
Time Frame: 1 time(Baseline)
|
Related FMA score(dependent) to predictors(independent) in three directions.
|
1 time(Baseline)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modified Ashworth Scale_Stiffness of chronic stroke
Time Frame: 1 time(Baseline)
|
Scoring for Biceps and Triceps
|
1 time(Baseline)
|
Range of motion_Health status chronic stroke
Time Frame: 1 time(Baseline)
|
Shoulder and elbow joint range of motion
|
1 time(Baseline)
|
Trunk impairment scale(TIS)_Health status chronic stroke
Time Frame: 1 time(Baseline)
|
|
1 time(Baseline)
|
Postural assessment scale for stroke(PASS)_Health status chronic stroke
Time Frame: 1 time(Baseline)
|
|
1 time(Baseline)
|
Fugl_Meyer Assessment(FMA)_Health status chronic stroke
Time Frame: 1 time(Baseline)
|
Upper extremity
|
1 time(Baseline)
|
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.
- 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, Avon). 2019 Mar;63:201-206. doi: 10.1016/j.clinbiomech.2019.03.011. Epub 2019 Mar 19.
- 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.
- 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 (Estimated)
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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