Clinical trial NCT06876597: Motor-Cognitive Interactive Upper Limb Robot Rehabilitation for Post-Stroke Motor Dysfunction
Official title: Motor-Cognitive Interactive Upper Limb Rehabilitation Robot Intervention for Post-Stroke Motor Dysfunction: A Multicenter Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: upeer
motor-cognitive interaction
robot
Lead sponsor: Fujian University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Fujian University of Traditional Chinese Medicine Affiliated Rehabilitation Hospital
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: China Rehabilitation Research Center
name: Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China
name: Shanghai Sunshine Rehabilitation Center
First posted: 2025-03-14
Enrollment: 1047
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Fugl-Meyer Upper Extremity Scale
timeFrame: 4 weeks (post-intervention)
Secondary outcomes:
measure: Fugl-Meyer Upper Extremity Scale
timeFrame: 3 months (post-intervention follow-up)
measure: Upper limb kinematics during standardized 3D grid tasks
timeFrame: 4 weeks
measure: Upper Limb Muscle Strength Assessment
timeFrame: 4 weeks, 3 months
measure: Modified Barthel Index
timeFrame: 4 weeks, 3 months
measure: Montreal Cognitive Assessment
timeFrame: 4 weeks, 3 months
measure: Auditory Verbal Learning Test
timeFrame: 4 weeks, 3 months
measure: Trail Making Test Part A
timeFrame: 4 weeks, 3 months
measure: Trail Making Test Part B
timeFrame: 4 weeks, 3 months
measure: Stroke-Specific Quality of Life Scale
timeFrame: 4 weeks, 3 months
Other outcomes:
measure: Exercise-associated Blood Biomarkers
timeFrame: 4 weeks
measure: Multimodal Neuroimaging Analysis
timeFrame: 4 weeks
Locations:
city: Fuzhou
country: China
facility: Fujian University of Traditional Chinese Medicine
Study officials:
References: