Compensatory Kinematic Movements in Various Directions After Stroke

June 30, 2023 updated by: José Casaña Granell, University of Valencia

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

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

Study Overview

Status

Recruiting

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.

Study Type

Observational

Enrollment (Estimated)

96

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Ulju
      • Ulsan, Ulju, Korea, Republic of, 44919
        • Recruiting
        • Ulsan National Institute of Science and Technology
        • Contact:
          • HYEKYUNG HEO, Bachelor
          • Phone Number: +821085801981

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

  • 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)
Range of motion_Health status chronic stroke
Time Frame: 1 time(Baseline)

Shoulder and elbow joint range of motion

  • Shoulder flexion, adduction, abduction, external rotation, internal rotation
  • Elbow flexion, extension
1 time(Baseline)
Trunk impairment scale(TIS)_Health status chronic stroke
Time Frame: 1 time(Baseline)
  • Static sitting balance
  • Dynamic sitting balance
  • Coordination
  • Total score is 23 points
1 time(Baseline)
Postural assessment scale for stroke(PASS)_Health status chronic stroke
Time Frame: 1 time(Baseline)
  • Maintaining posture

    1. Sitting without support
    2. Standing with support
    3. Standing without support
    4. Standing on non paretic leg
    5. 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)
Fugl_Meyer Assessment(FMA)_Health status chronic stroke
Time Frame: 1 time(Baseline)

Upper extremity

  • Shoulder, Elbow and Forearm

    1. Reflex activity
    2. Volitional movement within synergies
    3. Volitional movement mixing synergies
    4. Volitional movement with little or no synergy
    5. Normal reflex activity
  • Wrist
  • Hand
  • Coordination/Speed
  • Total score is 66 points
1 time(Baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2022

Primary Completion (Actual)

June 30, 2023

Study Completion (Estimated)

August 10, 2023

Study Registration Dates

First Submitted

December 21, 2022

First Submitted That Met QC Criteria

January 5, 2023

First Posted (Actual)

January 12, 2023

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 30, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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