## Protocol Section
### Identification Module
**NCT ID:** NCT04265079

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

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

#### Organization Study ID Info
**ID:** I2-CoRT_WTP9_BEMIHOMB
#### Organization
**Class:** OTHER
**Full Name:** Maastricht University
### Status Module
#### Completion Date
**Date:** 2021-08

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-02-07

**Type:** ACTUAL

**Last Update Submit Date:** 2024-02-05

**Overall Status:** WITHDRAWN

#### Primary Completion Date
**Date:** 2021-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-02

**Type:** ESTIMATED

**Status Verified Date:** 2024-02

#### Study First Post Date
**Date:** 2020-02-11
**Type:** ACTUAL
**Study First Submit Date:** 2020-01-22
**Study First Submit QC Date:** 2020-02-10
**Why Stopped:** The study could not be executed due to COVID-19 regulations.
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Jessa Hospital

#### Lead Sponsor

**Class:** OTHER

**Name:** Maastricht University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Stroke

- Upper Extremity Dysfunction

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Masking Description:** Study focusses on within participant comparison and cannot be blinded.

**Primary Purpose:** OTHER

#### Enrollment Info

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: Additional weight at hand

**Label:** Added weight to hand

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Added weight to hand

**Description:** Added weight of an inactive hand orthosis (300 gram)

**Name:** Additional weight at hand

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Score

**Measure:** Action Research Arm Test

**Time Frame:** 0 weeks

**Description:** Score

**Measure:** Action Research Arm Test

**Time Frame:** 8 weeks

**Description:** Score

**Measure:** Fugl-Meyer

**Time Frame:** 0 weeks

**Description:** Score

**Measure:** Fugl-Meyer

**Time Frame:** 8 weeks

**Description:** Score

**Measure:** Box and Blocks

**Time Frame:** 0 weeks

**Description:** Score

**Measure:** Box and Blocks

**Time Frame:** 8 weeks

**Description:** Joint angles

**Measure:** Upper extremity kinematics

**Time Frame:** 0 weeks

**Description:** Joint angles

**Measure:** Upper extremity kinematics

**Time Frame:** 8 weeks

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002561

- Term: Cerebrovascular Disorders

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M22306

- Name: Stroke

- Relevance: HIGH

- As Found: Stroke

- ID: M5810

- Name: Cerebrovascular Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000020521

- Term: Stroke

### Misc Info Module

- Version Holder: 2024-05-24
