Clinical trial NCT05683158: Compensatory Kinematic Movements in Various Directions After Stroke
Official title: Compensatory Kinematic Movement for Reaching Task in Various Directions in After Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Stroke
Hemiplegia, Spastic
Keywords: Chronic stroke
Reaching task
Motion capture
Lead sponsor: University of Valencia
Sponsor class: OTHER
Collaborators: name: Ulsan National Institute of Science and Technology
First posted: 2023-01-12
Enrollment: 96
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Recruit research participants from the healthy group of 61 participants at the gym for the disabled of Ulsan city and Ulsan national institute of science and technology. Another group of 35 patients who enter the largest gym for the disabled of Ulsan city.

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

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_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.

Eligibility criteria: 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

Primary outcomes:
measure: Differences in Spatial Measurements of Trunk Dislocation Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients
timeFrame: 1 time (Baseline)
measure: Differences in Spatial Measurements of Elbow and Shoulder Angle Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients
timeFrame: 1 time (Baseline)
measure: Differences in Temporal Measurements of Movement Unit Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients
timeFrame: 1 time (Baseline)
measure: Differences in Temporal Measurements of Hand Movement Time Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients
timeFrame: 1 time (Baseline)
measure: Differences in Temporal Measurements of Hand Velocity Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients
timeFrame: 1 time (Baseline)
measure: Differences in Temporal Measurements of Elbow Extension Acceleration Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients
timeFrame: 1 time (Baseline)
measure: Difference of the Components Temporal Measurements Between Healthy and Stroke
timeFrame: 1 time (Baseline)
Secondary outcomes:
measure: Comparison of Fugl-Meyer Assessment Scores Between Chronic Stroke Patients and Healthy
timeFrame: Baseline
Other outcomes:
measure: Comparison of Modified Ashworth Scale Between Chronic Stroke Patients and Healthy Controls
timeFrame: Baseline
measure: Range of motion_Health Status Chronic Stroke
timeFrame: Baseline
measure: Trunk Impairment Scale(TIS)_Health Status Chronic Stroke
timeFrame: 1 time(Baseline)
measure: Postural Assessment Scale for Stroke(PASS)_Health Status Chronic Stroke
timeFrame: Baseline
measure: Fugl_Meyer Assessment(FMA)_Health Status Chronic Stroke
timeFrame: Baseline
measure: Modified Ashworth Scale_Stiffness of Chronic Stroke
timeFrame: Baseline
Locations:
city: Ulsan
country: Korea, Republic of
facility: Ulsan National Institute of Science and Technology
state: Ulju
Study officials:
affiliation: University of Valencia
name: Jóse Casaña Granell, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Valencia
name: Joaquin Calatayud Villalba, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ulsan National Institute of Science and Technology
name: Sang Hoon Kang, PhD
role: PRINCIPAL_INVESTIGATOR
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