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

NCT06435624 | Completed Results

• 1 other identifier: NJKF202401001
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stroke

Outcome Measures

Primary Outcomes (4)

• Fugl-Meyer Assessment for Upper Extremity (FMA-UE)

  The FMA-UE consists of 33 items across nine components, including reflex action, synergy, and coordination, with a maximum score of 66 points. Each items is scored from 0 (no ability) to 2 (full ability), with higher scores indicating better upper limb motor function.

  From enrollment to the end of treatment at 4 weeks

• Active Participation Proportion

  Active Participation Proportion (APP) is measured using the benchmark evaluation system within the intelligent rehabilitation robot training system. The robotic arm's mechanical sensor continuously detects the force exerted by the patient during the test game and quantifies APP as the ratio of the patient's applied force to the total force required to complete the task (%). A higher APP indicates greater voluntary effort in movement execution. Since the test game difficulty is fixed, APP increases as the patient's motor ability improves.

  From enrollment to the end of treatment at 4 weeks

• Trajectory Deviation

  Trajectory Deviation (TD) is assessed by comparing the actual motion trajectory with a predefined reference trajectory using the intelligent rehabilitation robot training system. TD is calculated as the mean Euclidean distance (in mm) between discrete points along the actual movement path and the nearest corresponding points on the reference trajectory. This metric provides a measure of point-specific accuracy and precision in following the ideal movement path, with smaller TD values indicating better trajectory control.

  From enrollment to the end of treatment at 4 weeks

• Trajectory Tracking Error

  Description: Trajectory Tracking Error (TTE) quantifies the cumulative deviation between the actual movement path and the predefined reference trajectory. It is computed as the sum of absolute differences in trajectory length between the two paths (in mm). TTE reflects overall movement efficiency and smoothness, capturing the patient's ability to maintain an optimal movement path throughout the task. A lower TTE indicates better movement planning and motor control.

  From enrollment to the end of treatment at 4 weeks

Study Arms (3)

IRAT group

EXPERIMENTAL

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

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

RFE group

ACTIVE COMPARATOR

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

Other: repetitive facilitative exercise

CT group

ACTIVE COMPARATOR

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

Other: conventional therapy

Interventions

intelligent robotic-assisted training DEVICE

Using an intelligent robotic-assisted training (IRAT) system to simulate a real work environment, providing functional oriented treatment for stroke patients and improving upper limb motor function. The instrument used is the Burt upper limb robot training system produced by Estun Medical Co., Ltd.

IRAT group

repetitive facilitative exercise OTHER

Repetitive facilitative exercise (RFE) is a new technology that combines multiple sensory stimuli and achieves facilitation and reinforcement of the reconstruction of paralyzed neural pathways through repeated and extensive directional exercise.

IRAT group; RFE group

conventional therapy OTHER

Basic training, including passive joint movement and activities of daily living exercise.

CT group

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing Mingzhou Rehabilitation Hospital: lead

Study Sites (1)

Nanjing Mingzhou Rehabilitation Hospital

Nanjing, Jiangsu, 210046, China

Location

Related Publications (1)

• Zhang JZ, Chen J, Liu XL, Yan LB, Xu SM. Effectiveness of intelligent robotic-assisted training system combined with repetitive facilitative exercise on upper limb motor function after stroke: a randomized controlled trial. BMC Sports Sci Med Rehabil. 2025 Jul 3;17(1):178. doi: 10.1186/s13102-025-01234-y.

  PMID: 40611355 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The intervention period was relatively short and lacked long-term follow-up.

Results Point of Contact

• Title: Jingzhi Zhang
• Organization: Nanjing Mingzhou Rehabilitation Hospital

170787717@qq.com

16677137704

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: PRINCIPAL INVESTIGATOR
• PI Title: technician

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 30, 2024
• Study Start: June 15, 2024
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: March 5, 2025
• Results First Posted: March 5, 2025

Record last verified: 2025-02

Locations

CN (1)