I2-CoRT WTP9: Upper Extremity Motor Intervention, Use of Hand Orthosis in People Post-stroke

February 5, 2024 updated by: Maastricht University

I2-CoRT WTP9 Bovenste Extremiteit Motoriek Interventie Met Hand Orthese Bij Mensen na Een Beroerte

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Relapse during study
  • Secundary complications limiting upper extremity performance

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Added weight to hand
Other: Additional weight at hand
Added weight of an inactive hand orthosis (300 gram)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Action Research Arm Test
Time Frame: 0 weeks
Score
0 weeks
Action Research Arm Test
Time Frame: 8 weeks
Score
8 weeks
Fugl-Meyer
Time Frame: 0 weeks
Score
0 weeks
Fugl-Meyer
Time Frame: 8 weeks
Score
8 weeks
Box and Blocks
Time Frame: 0 weeks
Score
0 weeks
Box and Blocks
Time Frame: 8 weeks
Score
8 weeks
Upper extremity kinematics
Time Frame: 0 weeks
Joint angles
0 weeks
Upper extremity kinematics
Time Frame: 8 weeks
Joint angles
8 weeks

Collaborators and Investigators

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

Sponsor

Maastricht University

Collaborators

Jessa Hospital

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 (Estimated)

February 1, 2021

Primary Completion (Estimated)

June 1, 2021

Study Completion (Estimated)

August 1, 2021

Study Registration Dates

First Submitted

January 22, 2020

First Submitted That Met QC Criteria

February 10, 2020

First Posted (Actual)

February 11, 2020

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I2-CoRT_WTP9_BEMIHOMB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Stroke

Clinical Trials on Additional weight at hand

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Arab Emirates

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe