A Feasible Smart Upper Limb Rehabilitation Model for Patients With Stroke and Spinal Cord Injuries
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: Robot-assisted therapy, Task-oriented training.
- Who it may be relevant to
- Registry conditions: Stroke, Spinal Cord Injuries. Basic parameters: 20 years — 79 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
- Taiwan
- 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
Establishment of a Feasible Smart Upper Limb Rehabilitation Model in Post-pandemic Era: Examples for Patients With Stroke and Spinal Cord Injuries
Overview
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.
Interventions
- Other 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. - 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.
Primary outcome measures
- Fugl-Meyer Assessment - Upper Extremity -Stroke Group - Baseline [Time frame: Baseline, 4 weeks after baseline]
- Fugl-Meyer Assessment - Upper Extremity -Stroke Group - 4 weeks after baseline [Time frame: Baseline, 4 weeks after baseline]
- Motor Activity Log -Stroke Group - Baseline [Time frame: Baseline, 4 weeks after baseline]
- Motor Activity Log -Stroke Group - 4 weeks after baseline [Time frame: Baseline, 4 weeks after baseline]
- Range of Motion -Stroke Group - Baseline [Time frame: Baseline, 4 weeks after baseline]
- Range of Motion -Stroke Group - 4 weeks after baseline [Time frame: Baseline, 4 weeks after baseline]
- Box and Block Test -Stroke Group - Baseline [Time frame: Baseline, 4 weeks after baseline]
- Box and Block Test -Stroke Group - 4 weeks after baseline [Time frame: Baseline, 4 weeks after baseline]
- Modified Tardieu Scale -Stroke Group - Baseline [Time frame: Baseline, 4 weeks after baseline]
- Modified Tardieu Scale -Stroke Group - 4 weeks after baseline [Time frame: Baseline, 4 weeks after baseline]
Eligibility 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.
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
Taiwan · 2 centers
- National Cheng-Kung University Hospital — Tainan
- Chi Mei Medical Center — Tainan
Identifiers
NCT: NCT06215625 · A-ER-110-563