A Feasible Smart Upper Limb Rehabilitation Model for Patients With Stroke and Spinal Cord Injuries

NCT ID: NCT06215625

Last Updated: 2024-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-31

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this clinical trial is to investigate the effectiveness of the developed application and exoskeleton robot devices for home-based training in stroke patients and patients with spinal cord injuries. The application that uses an Internet of Things (IoT) platform to enable remote monitoring of rehabilitation progress by clinical practitioners. Simultaneously, it seeks to assist the execution of patient movements through devices.

In patients with stroke, half of the participants will be assigned to experimental group, receiving a smart upper limb motor rehabilitation system for home program. The other half will be assigned to control group, receiving a traditional home program. In patients with spinal cord injuries. Participants will follow the same allocation method for home-based intervention.

Researchers will conduct an analysis before and after intervention, examining progress in motor function, activities of daily living, and quality of life.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke Spinal Cord Injuries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Stroke: TIGER group

Participants in the TIGER (tenodesis-induced-grip exoskeleton robot) group will operate the TIGER system. They will undergo a 30-minute home-based training program twice a day, 5 days a week for 4 weeks.

Group Type EXPERIMENTAL

Robot-assisted therapy

Intervention Type OTHER

The TIGER system provides assistance for activities of daily living. Continuous passive mode of TIGER system provides passive range of motion as warm-up. Functional mode TIGER system provides functional training.

Stroke: TOT group

Participants in the TOT (task-oriented training) group will receive task-oriented training as home program. They will undergo a 30-minute home-based training program twice a day, 5 days a week for 4 weeks.

Group Type ACTIVE_COMPARATOR

Task-oriented training

Intervention Type OTHER

The TOT group will practice sensorimotor techniques for warming up, and then they will practice various functional tasks based on task-oriented approach.

Spinal cord injury: TIGER group

Participants in the TIGER (tenodesis-induced-grip exoskeleton robot) group will operate the TIGER system. They will undergo a 40-minute home-based training program once a day, 5 days a week for 4 weeks.

Group Type EXPERIMENTAL

Robot-assisted therapy

Intervention Type OTHER

The TIGER system provides assistance for activities of daily living. Continuous passive mode of TIGER system provides passive range of motion as warm-up. Functional mode TIGER system provides functional training.

Spinal cord injury: TOT group

Participants in the TOT (task-oriented training) group will receive task-oriented training as home program. They will undergo a 40-minute home-based training program once a day, 5 days a week for 4 weeks.

Group Type ACTIVE_COMPARATOR

Task-oriented training

Intervention Type OTHER

The TOT group will practice sensorimotor techniques for warming up, and then they will practice various functional tasks based on task-oriented approach.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Robot-assisted therapy

The TIGER system provides assistance for activities of daily living. Continuous passive mode of TIGER system provides passive range of motion as warm-up. Functional mode TIGER system provides functional training.

Intervention Type OTHER

Task-oriented training

The TOT group will practice sensorimotor techniques for warming up, and then they will practice various functional tasks based on task-oriented approach.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 20-79 years old.
* The score of Montreal Cognitive Assessment is more than or equal to 26.
* The unilateral hemorrhagic or ischemic participants.
* The performance of upper limb movement is affected by damage to brain cells.


* 20-65 years old.
* The score of Mini-Mental Status Examination is more than or equal to 25.
* Diagnosed as incomplete spinal cord injury at the C5 or C6 level.

Exclusion Criteria

* Underwent sugery on the shoulder, elbow or wrist.
* Severe pain in upper limb.
* Another muscular or neurological diseases that effects motor performance.


* Underwent sugery on the shoulder, elbow or wrist.
* Severe pain in upper limb.
* Another muscular or neurological diseases that effects motor performance.
Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cheng-Kung University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Li-Chieh Kuo, Ph.D

Role: PRINCIPAL_INVESTIGATOR

National Cheng Kung University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Cheng-Kung University Hospital

Tainan City, , Taiwan

Site Status RECRUITING

Chi Mei Medical Center

Tainan City, , Taiwan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Li-Chieh Kuo, Ph.D

Role: CONTACT

886-62353535 ext. 5908

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Li-Chieh Kuo

Role: primary

886-62353535 ext. 5908

Lin-Yen Chang, B.S.

Role: primary

886-2812811 ext. 55010

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A-ER-110-563

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Evaluation of Robot Assisted Neuro-Rehabilitation
NCT01253018 COMPLETED PHASE1/PHASE2