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

Stroke Clinical 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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06435624
• Other study ID #: NJKF202401001
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: August 2024

Study information

• Verified date: May 2024
• Source: Nanjing Mingzhou Rehabilitation Hospital
• Contact: Jingzhi Zhang
• Phone: +86-16677137704
• Email: 170787717[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• intelligent rehabilitation robot training system
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.

Other:
• repetitive facilitative exercise
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.
• conventional therapy
Basic training, including passive joint movement and activities of daily living exercise.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Mingzhou Rehabilitation Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Assessment (FMA)	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.	From enrollment to the end of treatment at 4 weeks
Primary	Active participation proportion	Use the benchmark evaluation system included with intelligent rehabilitation robot training system (in %)	From enrollment to the end of treatment at 4 weeks
Primary	Trajectory deviation	Use the benchmark evaluation system included with intelligent rehabilitation robot training system (in mm)	From enrollment to the end of treatment at 4 weeks
Primary	Trajectory tracking error	Use the benchmark evaluation system included with intelligent rehabilitation robot training system (in mm)	From enrollment to the end of treatment at 4 weeks
Primary	Action Research Arm Test (ARAT)	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.	From enrollment to the end of treatment at 4 weeks
Secondary	Range of motion (ROM)		From enrollment to the end of treatment at 4 weeks
Secondary	Modified Ashworth Scale (MAS)	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.	From enrollment to the end of treatment at 4 weeks