Compensatory Kinematic Movements in Various Directions After Stroke

Cerebral Stroke Clinical Trial

Official title:

Compensatory Kinematic Movement for Reaching Task in Various Directions in After Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05683158
• Other study ID #: Kinematic movements of stroke
• Status: Recruiting
• Start date: August 10, 2022
• Est. completion date: August 10, 2023

Study information

• Verified date: June 2023
• Source: University of Valencia
• Contact: Ae Non Lee, Master
• Phone: +811075442844
• Email: aenon[@]alumni.uv.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is cross-sectional study. By comparing kinematic analysis between stroke and healthy subjects in various directions, this investigation analyzes the compensatory kinematic movement for reaching task in stroke survivors

Description:

After Institutional Review Board approval, It recruits 2 groups. one group is elderly and another group is stroke survivors. the stroke group that meets the criteria. Another group is age matching of the stroke and not having an orthopedic or neurological disease. Participants of all the groups are assessed for kinematic by motion capture During reaching arm(affected side; stroke group, non-dominant side; healthy group) in 3 directions(medial_45, forward_90 and lateral_135 degrees). Retroreflective markers are placed on 11 anatomical place (3th metacarpal joint, both acromion, elbow lateral and medial epicondyle, lateral and medial styloid process, xyphoid process, sternum, C7, T4). Participants reach to a bell as quickly as possible in three directions. The subject reach to a bell 5 times in each direction and assess clinical evaluation such as Fugl Meyer Assessment, Postural Assessment Scale, Modified Ashworth Scale, shoulder-elbow range of motion and Trunk Instability scale.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: August 10, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Stroke
• Hemiplegia
• Hemiplegia, Spastic
• Stroke

Locations

Country	Name	City	State
Korea, Republic of	Ulsan National Institute of Science and Technology	Ulsan	Ulju

Sponsors (2)

Lead Sponsor	Collaborator
University of Valencia	Ulsan National Institute of Science and Technology

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (13)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Modified Ashworth Scale_Stiffness of chronic stroke	Scoring for Biceps and Triceps; MAS 0: No increase in tone; MAS 1: slight increase in tone giving a catch when slight increase in muscle t-tone, manifested by the limb was moved in flexion or extension.; MAS 1+: slight increase in muscle tone, manifested by a catch followed by minimal resistance throughout (ROM ); MAS 2: more marked increase in tone but more marked increased in muscle tone through most limb easily flexed; MAS 3: considerable increase in tone, passive movement difficult; MAS 4: limb rigid in flexion or extension	1 time(Baseline)
Other	Range of motion_Health status chronic stroke	Shoulder and elbow joint range of motion; Shoulder flexion, adduction, abduction, external rotation, internal rotation; Elbow flexion, extension	1 time(Baseline)
Other	Trunk impairment scale(TIS)_Health status chronic stroke	Static sitting balance; Dynamic sitting balance; Coordination; Total score is 23 points	1 time(Baseline)
Other	Postural assessment scale for stroke(PASS)_Health status chronic stroke	Maintaining posture; Sitting without support; Standing with support; Standing without support; Standing on non paretic leg; Standing on paretic leg; Changing a posture; 6.Supine to paretic side lateral 7.Supine to non-paretic side lateral 8.Supine to sitting up on the edge mat 9.Sitting on the edge of mat to supine 10.Sitting to standing up 11.Standing up to sitting down 12.Standing, picking up a pencil from the floor; Total score is 36 points	1 time(Baseline)
Other	Fugl_Meyer Assessment(FMA)_Health status chronic stroke	Upper extremity; Shoulder, Elbow and Forearm; Reflex activity; Volitional movement within synergies; Volitional movement mixing synergies; Volitional movement with little or no synergy; Normal reflex activity; Wrist; Hand; Coordination/Speed; Total score is 66 points	1 time(Baseline)
Primary	Difference of the components temporal measurements between healthy and stroke	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)
Primary	Difference of the components spatial measurements between healthy and stroke	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	Relationship between clinical score and kinematic variable in each direction	Related FMA score(dependent) to predictors(independent) in three directions.	1 time(Baseline)