Compensatory Kinematic Movements in Various Directions After Stroke

Sponsor

University of Valencia (Other)

Overall Status

Recruiting

CT.gov ID

NCT05683158

Collaborator

Ulsan National Institute of Science and Technology (Other)

100

Enrollment

Location

Anticipated Duration (Months)

9.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Cerebral Stroke Hemiplegia, Spastic

Detailed 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_120 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Aug 10, 2022

Anticipated Primary Completion Date :

May 10, 2023

Anticipated Study Completion Date :

Jul 10, 2023

Arms and Interventions

Arm	Intervention/Treatment
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_120 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_120 degrees)

Arm

Intervention/Treatment

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_120 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_120 degrees)

Outcome Measures

Primary Outcome Measures

Difference of the components temporal measurements between healthy and stroke [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_120 degrees). Participants reach to a bell as quickly as possible. 3th joint is calculated for quantitative measurements.
Difference of the components spatial measurements between healthy and stroke [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_120 degrees). Participants reach to a bell as quickly as possible. 3th joint is calculated for quantitative measurements.

Secondary Outcome Measures

Relationship between clinical score and kinematic variable in each direction [1 time(Baseline)]
Related FMA score(dependent) to predictors(independent) in three directions.

Other Outcome Measures

Modified Ashworth Scale_Stiffness of chronic stroke [1 time(Baseline)]
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
Range of motion_Health status chronic stroke [1 time(Baseline)]
Shoulder and elbow joint range of motion Shoulder flexion, adduction, abduction, external rotation, internal rotation Elbow flexion, extension
Trunk impairment scale(TIS)_Health status chronic stroke [1 time(Baseline)]
Static sitting balance Dynamic sitting balance Coordination Total score is 23 points
Postural assessment scale for stroke(PASS)_Health status chronic stroke [1 time(Baseline)]
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
Fugl_Meyer Assessment(FMA)_Health status chronic stroke [1 time(Baseline)]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ulsan National Institute of Science and Technology	Ulsan	Ulju	Korea, Republic of	44919

Sponsors and Collaborators

University of Valencia
Ulsan National Institute of Science and Technology

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