NCT04265079

Brief Summary

The upper extremity kinematics of people post-stroke will be monitored with/without an inactive hand orthosis (intervention: added weight to hand) during ARAT, Fugl-Meyer, and Box and Blocks tests. Measurements will occur right after inclusion and repeated once after 7-8 weeks. Upper extremity kinematics and test scores will indicate the influence of additional weight to hand as a possible confounder when, in the future, the hand orthosis would be used as a therapy tool.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable stroke

Status
withdrawn

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

First Submitted

Initial submission to the registry

January 22, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 11, 2020

Completed
12 months until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

4 months

First QC Date

January 22, 2020

Last Update Submit

February 5, 2024

Conditions

StrokeUpper Extremity Dysfunction

Outcome Measures

Primary Outcomes (8)

  • Action Research Arm Test

    Score

    0 weeks

  • Action Research Arm Test

    Score

    8 weeks

  • Fugl-Meyer

    Score

    0 weeks

  • Fugl-Meyer

    Score

    8 weeks

  • Box and Blocks

    Score

    0 weeks

  • Box and Blocks

    Score

    8 weeks

  • Upper extremity kinematics

    Joint angles

    0 weeks

  • Upper extremity kinematics

    Joint angles

    8 weeks

Study Arms (1)

Added weight to hand

EXPERIMENTAL
Other: Additional weight at hand

Interventions

Additional weight at handOTHER

Added weight of an inactive hand orthosis (300 gram)

Added weight to hand

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Post-stroke
  • Receive regular therapy at Jessa hospital
  • Able to willingly sign informed consent

You may not qualify if:

  • Relapse during study
  • Secundary complications limiting upper extremity performance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Study focusses on within participant comparison and cannot be blinded.
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2020

First Posted

February 11, 2020

Study Start

February 1, 2021

Primary Completion

June 1, 2021

Study Completion

August 1, 2021

Last Updated

February 7, 2024

Record last verified: 2024-02