NCT05683158

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 12, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2023

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

February 24, 2025

Completed
Last Updated

February 24, 2025

Status Verified

February 1, 2025

Enrollment Period

11 months

First QC Date

December 21, 2022

Results QC Date

July 14, 2023

Last Update Submit

February 2, 2025

Conditions

Keywords

Chronic strokeReaching taskMotion capture

Outcome Measures

Primary Outcomes (7)

  • 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.

    1 time (Baseline)

  • 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.

    1 time (Baseline)

  • 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.

    1 time (Baseline)

  • 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.

    1 time (Baseline)

  • 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.

    1 time (Baseline)

  • 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.

    1 time (Baseline)

  • 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.

    1 time (Baseline)

Secondary Outcomes (1)

  • Comparison of Fugl-Meyer Assessment Scores Between Chronic Stroke Patients and Healthy

    Baseline

Other Outcomes (6)

  • Comparison of Modified Ashworth Scale Between Chronic Stroke Patients and Healthy Controls

    Baseline

  • Range of motion_Health Status Chronic Stroke

    Baseline

  • Trunk Impairment Scale(TIS)_Health Status Chronic Stroke

    1 time(Baseline)

  • +3 more other outcomes

Study Arms (2)

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)

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ulsan National Institute of Science and Technology

Ulsan, Ulju, 44919, South Korea

Location

Related Publications (13)

  • 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.

    PMID: 29658937BACKGROUND
  • 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.

    PMID: 24481598BACKGROUND
  • 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.

    PMID: 30925379BACKGROUND
  • 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.

    PMID: 23181596BACKGROUND
  • 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.

    PMID: 27000446BACKGROUND
  • 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.

    PMID: 10775539BACKGROUND
  • 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.

    PMID: 11880893BACKGROUND
  • 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.

    PMID: 11460767BACKGROUND
  • 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.

    PMID: 9099186BACKGROUND
  • 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.

    PMID: 10502647BACKGROUND
  • 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.

    PMID: 32539738BACKGROUND
  • 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.

    PMID: 12819841BACKGROUND
  • 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.

    PMID: 33585418BACKGROUND

MeSH Terms

Conditions

StrokeHemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

the absence of randomization increased the risk of confounding bias.

Results Point of Contact

Title
PI. Jose Casaña Granell
Organization
Department of Physiotherapy, University of Valencia

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 21, 2022

First Posted

January 12, 2023

Study Start

August 10, 2022

Primary Completion

June 30, 2023

Study Completion

July 10, 2023

Last Updated

February 24, 2025

Results First Posted

February 24, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations