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

NCT06876597 | Recruiting DMC

• 1 other identifier: FujianUTCM-3
• Study Type: interventional
• Target: 1,047
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

upeer; motor-cognitive interaction; robot

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Upper Extremity Scale

  Score range 0-66, higher scores indicate better upper limb motor recovery.

  4 weeks (post-intervention)

Secondary Outcomes (9)

• Fugl-Meyer Upper Extremity Scale

  3 months (post-intervention follow-up)

• Upper limb kinematics during standardized 3D grid tasks

  4 weeks

• Upper Limb Muscle Strength Assessment

  4 weeks, 3 months

• Modified Barthel Index

  4 weeks, 3 months

• Montreal Cognitive Assessment

  4 weeks, 3 months

Other Outcomes (2)

• Exercise-associated Blood Biomarkers

  4 weeks

• Multimodal Neuroimaging Analysis

  4 weeks

Study Arms (3)

Motor-cognitive interactive robot-assisted training

EXPERIMENTAL

Device: Motor-cognitive interactive robot

Motor-focused robot-assisted training

EXPERIMENTAL

Device: Motor-focused robot

Conventional rehabilitation training

EXPERIMENTAL

Behavioral: Conventional rehabilitation training

Interventions

Motor-cognitive interactive robot DEVICE

Motor-cognitive interactive robot-assisted training integrates motor and cognitive rehabilitation using an upper limb rehabilitation robot. If patients cannot actively lift the robotic arm, an eye-tracking mode detects movement intention and guides the arm along predefined trajectories, adjusting motor and cognitive loads dynamically. As motor function improves, training shifts to an active mode with increased resistance. Patients complete cognitive tasks before moving the robotic arm, while the system monitors movement parameters and provides real-time feedback. Training consists of 60-minute sessions, five days per week for four weeks. Motor load progresses by increasing robotic arm speed or resistance, while cognitive load advances based on task accuracy, ensuring personalized and adaptive rehabilitation.

Motor-cognitive interactive robot-assisted training

Motor-focused robot DEVICE

Motor-focused robot-assisted training primarily emphasizes motor rehabilitation through the use of an upper limb rehabilitation robot. When patients are unable to actively lift the robotic arm, an eye-tracking mode is employed to guide movements, with adjustments made solely to the motor load. As motor function improves, the training transitions to an active mode, progressively increasing resistance while maintaining a constant, minimal level of cognitive difficulty. Patients are required to complete cognitive tasks before initiating movement of the robotic arm, while the system monitors key movement parameters and provides real-time feedback. Training consists of 60-minute sessions, five days per week for four weeks. Motor load is progressively increased by adjusting the speed or resistance of the robotic arm, while cognitive load remains consistently at the lowest level throughout the training.

Motor-focused robot-assisted training

Conventional rehabilitation training BEHAVIORAL

Conventional rehabilitation training adheres to internationally established guidelines and employs task-oriented approaches tailored to activities of daily living (ADLs). The therapeutic regimen incorporates fundamental motor skill exercises, including but not limited to grasp-and-release maneuvers, targeted reaching, fine motor skill development (e.g., button manipulation, zipper operation), and bilateral coordination tasks (e.g., garment folding, towel wringing). The intervention protocol emphasizes progressive task difficulty and functional task integration, with each session lasting 60 minutes. The treatment schedule consists of daily sessions, five times per week, over a four-week duration.

Conventional rehabilitation training

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Lidian Chen: lead
• Fujian University of Traditional Chinese Medicine Affiliated Rehabilitation Hospital: collaborator
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator
• China Rehabilitation Research Center: collaborator
• Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China: collaborator
• Shanghai Sunshine Rehabilitation Center: collaborator

Study Sites (1)

Fujian University of Traditional Chinese Medicine

Fuzhou, 350122, China

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Jingsong Wu

CONTACT

86+13609501214; jingsongwu01@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: March 14, 2025
• Study Start: April 8, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)