AzTrials
AzTrials

Cerebral StrokeNCT05683158

Compensatory Kinematic Movements in Various Directions After Stroke

An observational study of Cerebral Stroke and Hemiplegia, Spastic, run by University of Valencia at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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 Read more about this study

Who is it for?
Ages 40 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Cerebral Stroke, Hemiplegia, Spastic
How many people
96 participants
Where
1 siteSouth Korea
Study dates
10 Aug 2022to 10 Jul 2023
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • Stroke
  • Biceps>2, Triceps>2
  • Flaccid
  • Neglect syndrome
  • Have neurological disease and orthopedic disease
  • Lack of coordination

Trial locations and contacts

1 site in 1 country.

South Korea1 site
  • Ulsan National Institute of Science and Technology

    Ulsan, Ulju, 44919

Other trials in South Korea

About this study

Official title: 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

Read the 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.

Keywords
Chronic stroke, Reaching task, Motion capture
Medical subject headings
Stroke, Hemiplegia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05683158
Study groupRoleWhat they receive
chronic strokeThe 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)
HealthyMatching 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Differences in Spatial Measurements of Trunk Dislocation Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients

    Trunk dislocation (reaching phase in millimetre; mm) in reaching task. The measurements are detected in 3 directions (Forward_90, Lateral_135, Medial_45 degree). Participants reach to a bell as quickly as possible. 3rd joint is calculated for quantitative measurements.

    Measured: 1 time (Baseline)

  2. Differences in Spatial Measurements of Elbow and Shoulder Angle Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients

    Elbow extension and shoulder flexion angle (degree) in reaching task. The measurements are detected in 3 directions (Forward_90, Lateral_135, Medial_45 degree). Participants reach to a bell as quickly as possible. 3rd joint is calculated for quantitative measurements.

    Measured: 1 time (Baseline)

  3. Differences in Temporal Measurements of Movement Unit Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients

    Movement units are quantified by counting velocity peaks during the reaching task. A movement unit is defined as a velocity profile segment between a local minimum and the following maximum velocity that exceeds 20 mm/s, with a minimum time interval of 150 ms between subsequent peaks. This measure represents the smoothness of movement, where fewer movement units indicate smoother motion The measurements are detected in 3 directions (Forward_90, Lateral_135, Medial_45 degree). Participants reach to a bell as quickly as possible. 3rd joint is calculated for quantitative measurements.

    Measured: 1 time (Baseline)

  4. Differences in Temporal Measurements of Hand Movement Time Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients

    The period from hand tangential velocity movement onset to offset was the total time (entire time of reach and return phase [second]). The period when the tangential velocity exceeded 10% of its peak was termed hand movement onset, whereas that when the tangential velocity stayed below 10% of its peak was termed hand movement offset.

    The measurements are detected in 3 directions (Forward_90, Lateral_135, Medial_45 degree). Participants reach to a bell as quickly as possible. 3rd joint is calculated for quantitative measurements.

    Measured: 1 time (Baseline)

  5. Differences in Temporal Measurements of Hand Velocity Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients

    Tangential velocity was computed for the hand marker's velocity. Peak elbow angular velocity (rad/s) during elbow extension were measured The measurements are detected in 3 directions (Forward_90, Lateral_135, Medial_45 degree). Participants reach to a bell as quickly as possible. 3rd joint is calculated for quantitative measurements.

    Measured: 1 time (Baseline)

  6. Differences in Temporal Measurements of Elbow Extension Acceleration Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients

    Acceleration (rad/s2) during elbow extension was measured The measurements are detected in 3 directions (Forward_90, Lateral_135, Medial_45 degree). Participants reach to a bell as quickly as possible. 3rd joint is calculated for quantitative measurements.

    Measured: 1 time (Baseline)

  7. Difference of the Components Temporal Measurements Between Healthy and Stroke

    Tangential velocity was computed for the hand marker's velocity. The period when the tangential velocity exceeded 10% of its peak was termed hand movement onset, whereas that when the tangential velocity stayed below 10% of its peak was termed hand movement offset. Peak hand velocity (mm/s) was analyzed.

    The measurements are detected in 3 directions (Forward_90, Lateral_135, Medial_45 degree). Participants reach to a bell as quickly as possible. 3rd joint is calculated for quantitative measurements.

    Measured: 1 time (Baseline)

Secondary outcomes (1)
  1. Comparison of Fugl-Meyer Assessment Scores Between Chronic Stroke Patients and Healthy

    Related Fugl-Meyer Assessment score(dependent) to predictors(independent) in three directions.

    In sitting position, the sum of each subtotal score is 66 (maximum) and the minimum is 0. Subscales were summed to compute a total score. Cutoff scores defined 0~20: severe, 21 ~ 50: moderate, 51~66: mild

    1. Reflex activity_max 4 score, 2) Volitional movement within synergies_ max 18, 3) Volitional movement mixing synergies_ max 6, 4) Volitional movement with little or no synergy_ max 6, 5) Normal reflex activity_max 2, 6) Wrist movement_ max 10, 7) Hand movement with grasp_ max 14, 8) coordination/speed_max 6.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2023
  2. Study start10 Aug 2022
  3. Primary completion30 Jun 2023
  4. Study completion10 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05683158
Sponsor's protocol ID
Kinematic movements of stroke
Status last verified
Feb 2025
First submitted
21 Dec 2022
Last updated
24 Feb 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29658937
  • 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.

    PubMed 24481598
  • 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). 2019 Mar;63:201-206. doi: 10.1016/j.clinbiomech.2019.03.011. Epub 2019 Mar 19.

    PubMed 30925379
  • 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.

    PubMed 23181596
  • 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.

    PubMed 27000446
  • 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.

    PubMed 10775539
  • 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.

    PubMed 11880893
  • 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.

    PubMed 11460767
  • 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.

    PubMed 9099186
  • 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.

    PubMed 10502647
  • 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.

    PubMed 32539738
  • 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.

    PubMed 12819841
  • 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.

    PubMed 33585418

Questions about this trial

What is this clinical trial studying?

An observational study of Cerebral Stroke and Hemiplegia, Spastic, run by University of Valencia at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Differences in Spatial Measurements of Trunk Dislocation Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients (time frame: 1 time (Baseline)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05683158, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in