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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04265079
• Other study ID #: I2-CoRT_WTP9_BEMIHOMB
• Status: Withdrawn
• Phase: N/A
• Start date: February 2021
• Est. completion date: August 2021

Study information

• Verified date: February 2024
• Source: Maastricht University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke
• Upper Extremity Dysfunction

Intervention

Other:
• Additional weight at hand
Added weight of an inactive hand orthosis (300 gram)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University	Jessa Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Action Research Arm Test	Score	0 weeks
Primary	Action Research Arm Test	Score	8 weeks
Primary	Fugl-Meyer	Score	0 weeks
Primary	Fugl-Meyer	Score	8 weeks
Primary	Box and Blocks	Score	0 weeks
Primary	Box and Blocks	Score	8 weeks
Primary	Upper extremity kinematics	Joint angles	0 weeks
Primary	Upper extremity kinematics	Joint angles	8 weeks