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Effectiveness and safety evaluation research of intelligent force-controlled robot therapy (IFRT) on upper extremity rehabilitation in stroke patients : a multi-center randomized controlled trial

Effectiveness and safety evaluation research of intelligent force-controlled robot therapy (IFRT) on upper extremity rehabilitation in stroke patients : a multi-center randomized controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049509
Enrollment
Unknown
Registered
2021-08-02
Start date
2021-08-01
Completion date
Unknown
Last updated
2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

stroke

Interventions

Rehabilitation training group based on upper limb rehabilitation robot :Intelligent Force-Controlled Robot Therapy (IFRT) and Routine rehabilitation training

Sponsors

The Seventh Affiliated Hospital of Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.Stroke for the first time or recurrence and in compliance with the Chinese Guidelines for the Diagnosis and Treatment of Acute Stroke 2014 issued in 2015, confirmed by CT or MRI imaging scans of the head; 2.Course of illness >=1 month and <=6 months 3.Stable condition after brain injury 4.Age 18-85 years old 5.Upper limb motor dysfunction 6.Clear consciousness, good cardiopulmonary function, stable vital signs, and able to cooperate well with training 7.Commit to abide by the research procedures, cooperate with the implementation of the whole process research and sign the informed consent form 8.Women during the reproductive period should have contraception for at least 1 month before the screening, and promise to use contraception throughout the study period and continue until the specified time after the end of the study 9.Males during the reproductive period should use condoms or other contraceptive methods to ensure effective contraception for their spouses 10.Commit to follow the precautions related to lifestyle during the study

Exclusion criteria

Exclusion criteria: 1. Hypertonia Ashworth grade >= grade 3 or upper limb muscle strength 200mmHg or diastolic blood pressure > 110mmHg) with poor control of diabetes mellitus; 3. Shoulder joint with severe pain; 4. Severe limitation of passive range of motion of shoulder and elbow joints; 5. Patients with refractory or multiple epilepsy; 6. Past history of severe upper and lower extremity joint diseases.

Design outcomes

Primary

MeasureTime frame
Wolf Motor Function Test;Action Research Arm Test;

Secondary

MeasureTime frame
the Upper Extremity Section of the Fugl-Meyer Assessment;the Upper Extremity Section of the Modified Ashworth Scale;Instrumental Activity of Daily Living;Intelligent Force-Controlled Robot Systemic Assessments;

Countries

China

Contacts

Public ContactWang Pu

The Seventh Affiliated Hospital of Sun Yat-Sen University

hxkfwp@163.com+86 13816059952

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026