Motor-Cognitive Interactive Upper Limb Robot Rehabilitation for Post-Stroke Motor Dysfunction

Lidian Chen

Status: Enrolling

Conditions: Stroke

Treatments: Behavioral: Conventional rehabilitation training; Device: Motor-focused robot; Device: Motor-cognitive interactive robot

Study type: Interventional

Funder types: Other

Identifiers

NCT06876597

FujianUTCM-3

Details and patient eligibility

About

This study aims to investigate the effects of motor-cognitive interactive robot-assisted training on improving upper limb motor dysfunction after stroke. By observing different combinations of motor and cognitive components in the training, the study will clarify the relationship between the proportion of motor and cognitive elements and the recovery of upper limb motor function. The goal is to optimize the training protocol for upper limb rehabilitation robots and enhance their therapeutic outcomes.

Participants will be randomly assigned to one of three groups: motor-cognitive interactive robot-assisted training, motor-focused robot-assisted training, or conventional rehabilitation training. Training sessions will last 60 minutes, occur 5 times per week, and continue for 4 weeks. Researchers will measure changes in upper limb function and monitor for any adverse events during the training.

Enrollment: 1,047 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of stroke confirmed by CT or MRI.
2. Age between 40 and 80 years, with no gender restrictions.
3. First-ever stroke with unilateral limb paralysis.
4. Onset of stroke between 2 weeks and 6 months prior, with an FMA-UE score of 8-44.
5. Willingness to participate and provide written informed consent.

Exclusion criteria

1. History of neuromuscular diseases, malignant tumors, or other severe uncontrolled conditions, including cardiac, renal, or hepatic diseases.
2. Seated balance score < 2, or inability to maintain a sitting position for more than 60 minutes.
3. Modified Ashworth Scale score > 2.
4. Visual Analog Scale (VAS) score > 3 for hemiplegic shoulder pain.
5. Boston Diagnostic Aphasia Examination score < 3.
6. Severe visual impairment preventing participation in upper limb robot-assisted rehabilitation training.
7. Hamilton Depression Scale score >17, indicating moderate to severe depressive symptoms.
8. Participation in other clinical trials that may interfere with the results of this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,047 participants in 3 patient groups

Motor-cognitive interactive robot-assisted training

Experimental group

Treatment:

Device: Motor-cognitive interactive robot

Motor-focused robot-assisted training

Experimental group

Treatment:

Device: Motor-focused robot

Conventional rehabilitation training

Experimental group

Treatment:

Behavioral: Conventional rehabilitation training