StrokeNCT04265079
I2-CoRT WTP9: Upper Extremity Motor Intervention, Use of Hand Orthosis in People Post-stroke
A study testing Additional weight at hand in people with Stroke and Upper Extremity Dysfunction, run by Maastricht University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Upper Extremity Dysfunction
- What is being tested?
- Additional weight at hand
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2021to Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post-stroke
- Receive regular therapy at Jessa hospital
- Able to willingly sign informed consent
Who cannot join
- Relapse during study
- Secundary complications limiting upper extremity performance
About this study
Official title: 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.
- Conditions
- Stroke, Upper Extremity Dysfunction
- Being tested
- Additional weight at hand
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional weight at handOther
Added weight of an inactive hand orthosis (300 gram)
| Study group | Role | What they receive |
|---|---|---|
| Added weight to hand | Experimental | Not described Receives: Other: Additional weight at hand |
What is being measured
The primary outcome is the main question the study is designed to answer.
Action Research Arm Test
Score
Measured: 0 weeks
Action Research Arm Test
Score
Measured: 8 weeks
Fugl-Meyer
Score
Measured: 0 weeks
Fugl-Meyer
Score
Measured: 8 weeks
Box and Blocks
Score
Measured: 0 weeks
Box and Blocks
Score
Measured: 8 weeks
Upper extremity kinematics
Joint angles
Measured: 0 weeks
Upper extremity kinematics
Joint angles
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study startFeb 2021 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionAug 2021 (estimated)
Why it stopped: The study could not be executed due to COVID-19 regulations.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Collaborators
- Jessa Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265079
- Sponsor's protocol ID
- I2-CoRT_WTP9_BEMIHOMB
- Status last verified
- Feb 2024
- First submitted
- 22 Jan 2020
- Last updated
- 7 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- I2-CoRT WTP9 Bovenste Extremiteit Motoriek Interventie Met Hand Orthese Bij Mensen na Een Beroerte
- ClinicalTrials.gov ID
- NCT04265079
- Acronym / sponsor ID
- I2-CoRT_WTP9_BEMIHOMB
- Conditions
- Stroke, Upper Extremity Dysfunction
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study could not be executed due to COVID-19 regulations.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Collaborators
- Jessa Hospital
- Study start
- Feb 2021 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 11 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Added weight to hand | Experimental | Other: Additional weight at hand |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Post-stroke
- Receive regular therapy at Jessa hospital
- Able to willingly sign informed consent
Key exclusion criteria (2 listed)
- Relapse during study
- Secundary complications limiting upper extremity performance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Additional weight at handAdded weight of an inactive hand orthosis (300 gram) | Other | Added weight to hand |
Primary outcome
Action Research Arm Test
Time frame: 0 weeks
Score
Action Research Arm Test
Time frame: 8 weeks
Score
Fugl-Meyer
Time frame: 0 weeks
Score
Fugl-Meyer
Time frame: 8 weeks
Score
Box and Blocks
Time frame: 0 weeks
Score
Box and Blocks
Time frame: 8 weeks
Score
Upper extremity kinematics
Time frame: 0 weeks
Joint angles
Upper extremity kinematics
Time frame: 8 weeks
Joint angles
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Additional weight at hand in people with Stroke and Upper Extremity Dysfunction, run by Maastricht University.
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 3 inclusion and 2 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: withdrawn, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Action Research Arm Test (time frame: 0 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Feb 2024.