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

National Cheng-Kung University

Status: Enrolling

Conditions: Spinal Cord Injuries; Stroke

Treatments: Other: Robot-assisted therapy; Other: Task-oriented training

Study type: Interventional

Funder types: Other

Identifiers

NCT06215625

A-ER-110-563

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: For patients with stroke

• 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.

Inclusion Criteria: For patients with spinal cord injury

• 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: For patients with stroke

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

Exclusion Criteria: For patients with spinal cord injury

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 4 patient groups

Stroke: TIGER group

Experimental group

Description:

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.

Treatment:

Other: Robot-assisted therapy

Stroke: TOT group

Active Comparator group

Description:

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.

Treatment:

Other: Task-oriented training

Spinal cord injury: TIGER group

Experimental group

Description:

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.

Treatment:

Other: Robot-assisted therapy

Spinal cord injury: TOT group

Active Comparator group

Description:

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.

Treatment:

Other: Task-oriented training