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Recruiting NCT06876597

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

No phase Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Motor-cognitive interactive robot, Motor-focused robot, Conventional rehabilitation training.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: 40 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Motor-Cognitive Interactive Upper Limb Rehabilitation Robot Intervention for Post-Stroke Motor Dysfunction: A Multicenter Randomized Controlled Study

Overview

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.

Interventions

  • Device Motor-cognitive interactive robot
    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
  • Device Motor-focused robot
    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 com
  • Behavioral Conventional rehabilitation training
    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 emph

Primary outcome measures

  • Fugl-Meyer Upper Extremity Scale [Time frame: 4 weeks (post-intervention)]
Secondary outcome measures (9)
  • Fugl-Meyer Upper Extremity Scale [Time frame: 3 months (post-intervention follow-up)]
  • Upper limb kinematics during standardized 3D grid tasks [Time frame: 4 weeks]
  • Upper Limb Muscle Strength Assessment [Time frame: 4 weeks, 3 months]
  • Modified Barthel Index [Time frame: 4 weeks, 3 months]
  • Montreal Cognitive Assessment [Time frame: 4 weeks, 3 months]
  • Auditory Verbal Learning Test [Time frame: 4 weeks, 3 months]
  • Trail Making Test Part A [Time frame: 4 weeks, 3 months]
  • Trail Making Test Part B [Time frame: 4 weeks, 3 months]
  • Stroke-Specific Quality of Life Scale [Time frame: 4 weeks, 3 months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Fujian University of Traditional Chinese Medicine — Fuzhou

Identifiers

NCT: NCT06876597 · FujianUTCM-3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗