## Protocol Section
### Identification Module
**NCT ID:** NCT06435624

**Brief Title:** Effectiveness of Intelligent Rehabilitation Robot Training System Combined With Repetitive Facilitative Exercise on Upper Limb Motor Function After Stroke: a Randomized Control Trial.

**Official Title:** Effectiveness of Intelligent Rehabilitation Robot Training System Combined With Repetitive Facilitative Exercise on Upper Limb Motor Function After Stroke: a Randomized Control Trial.

#### Organization Study ID Info
**ID:** NJKF202401001
#### Organization
**Class:** OTHER
**Full Name:** Nanjing Mingzhou Rehabilitation Hospital
### Status Module
#### Completion Date
**Date:** 2024-08

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-24

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-08

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Nanjing Mingzhou Rehabilitation Hospital

#### Responsible Party

**Investigator Affiliation:** Nanjing Mingzhou Rehabilitation Hospital

**Investigator Full Name:** Jingzhi Zhang

**Investigator Title:** technician

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** The goal of this clinical trial is to learn if intelligent rehabilitation robot training system combined with repetitive facilitative exercise (RFE) work to treat stroke in adults. The main questions it aims to answer are:

Does drug intelligent rehabilitation robot training system combined with RFE improve the upper limb motor function of participants? Can the combination of intelligent rehabilitation robot training system and RFE achieve better effects?

Researchers will compare 3 groups (RFE, intelligent rehabilitation robot training system under RFE, and conventional therapy) to see if intelligent rehabilitation robot training system and RFE works to treat stroke.

Participants will:

Receive treatment for 4 weeks Receive scale and instrument testing before and after treatment

### Conditions Module

**Conditions:**

- Stroke

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Intelligent rehabilitation robot training system under repetitive facilitative exercise (RFE)

**Intervention Names:**

- Device: intelligent rehabilitation robot training system

- Other: repetitive facilitative exercise

**Label:** Combined group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Repetitive facilitative exercise (RFE)

**Intervention Names:**

- Other: repetitive facilitative exercise

**Label:** RFE group

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Description:** Conventional therapy (CT)

**Intervention Names:**

- Other: conventional therapy

**Label:** CT group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Combined group

**Description:** Using an intelligent rehabilitation robot training system to simulate a real work environment, providing functional oriented treatment for stroke patients and improving upper limb motor function.

The instrument used is the Burt upper limb robot training system produced by Estun Medical Co., Ltd.

**Name:** intelligent rehabilitation robot training system

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Combined group

- RFE group

**Description:** Repetitive facilitative exercise (RFE) is a new technology that combines multiple sensory stimuli and achieves facilitation and reinforcement of the reconstruction of paralyzed neural pathways through repeated and extensive directional exercise.

**Name:** repetitive facilitative exercise

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- CT group

**Description:** Basic training, including passive joint movement and activities of daily living exercise.

**Name:** conventional therapy

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The FMA used to assess motor control such as sensation, range of motion, coordination, and speed. FMA in upper limb includes 33 items and ranges from 0 to 66; a maximum score indicates complete recovery of the limb.

**Measure:** Fugl-Meyer Assessment (FMA)

**Time Frame:** From enrollment to the end of treatment at 4 weeks

**Description:** Use the benchmark evaluation system included with intelligent rehabilitation robot training system (in %)

**Measure:** Active participation proportion

**Time Frame:** From enrollment to the end of treatment at 4 weeks

**Description:** Use the benchmark evaluation system included with intelligent rehabilitation robot training system (in mm)

**Measure:** Trajectory deviation

**Time Frame:** From enrollment to the end of treatment at 4 weeks

**Description:** Use the benchmark evaluation system included with intelligent rehabilitation robot training system (in mm)

**Measure:** Trajectory tracking error

**Time Frame:** From enrollment to the end of treatment at 4 weeks

**Description:** The ARAT is a measure of upper-extremity function that has 4 subsections: grip, grasp, pinch and gross movement. The ARAT score range is 0-57, with higher scores indicating better functionality.

**Measure:** Action Research Arm Test (ARAT)

**Time Frame:** From enrollment to the end of treatment at 4 weeks

#### Secondary Outcomes

**Measure:** Range of motion (ROM)

**Time Frame:** From enrollment to the end of treatment at 4 weeks

**Description:** The MAS score was used to evaluate spasticity of the affected upper limb. The higher the score of MAS (0, 1, 1+, 2, 3 and 4), the higher the degree of spasms.

**Measure:** Modified Ashworth Scale (MAS)

**Time Frame:** From enrollment to the end of treatment at 4 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* patients (18 to 74 years old) who suffered a first or second unilateral stroke
* chronic stroke (over 6 months from the onset)
* obvious upper limb movement disorders (FMA-UE scores from 25 to 42)
* ability to understand and follow simple directions

Exclusion Criteria:

* pregnant or lactating
* upper extremity contracture, pain, or trauma
* perceptual, apraxic, or cognitive deficits that lead to inability to follow verbal instructions
* unable to maintain sitting posture
* cerebellar lesion
* clinically unstable medical disorders
* inability to provide informed consent

**Maximum Age:** 74 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** 170787717@qq.com

**Name:** Jingzhi Zhang

**Phone:** +86-16677137704

**Role:** CONTACT

## 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: 2024-05-31
