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

Nanjing Mingzhou Rehabilitation Hospital

Status: Completed

Conditions: Stroke

Treatments: Other: conventional therapy; Other: repetitive facilitative exercise; Device: intelligent robotic-assisted training

Study type: Interventional

Funder types: Other

Identifiers

NCT06435624

NJKF202401001

Details and patient eligibility

About

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

Enrollment: 81 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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81 participants in 3 patient groups

IRAT group

Experimental group

Description:

The Intelligent robotic-assisted training (IRAT) group received a 30 minute RFE intervention and a 30 minute IRAT intervention.

Treatment:

Other: repetitive facilitative exercise

Device: intelligent robotic-assisted training

RFE group

Active Comparator group

Description:

The Repetitive facilitative exercise (RFE) group received a 60 minute RFE intervention.

Treatment:

Other: repetitive facilitative exercise

CT group

Active Comparator group

Description:

The Conventional therapy (CT) group received a 60 minute conventional rehabilitation intervention.

Treatment:

Other: conventional therapy