Clinical trial NCT06215625: A Feasible Smart Upper Limb Rehabilitation Model for Patients With Stroke and Spinal Cord Injuries
Official title: Establishment of a Feasible Smart Upper Limb Rehabilitation Model in Post-pandemic Era: Examples for Patients With Stroke and Spinal Cord Injuries
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Spinal Cord Injuries
Keywords: stroke
spinal cord injury
robot-assisted therapy
tele-rehabilitation
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: Fugl-Meyer Assessment - Upper Extremity -Stroke Group - Baseline
timeFrame: Baseline, 4 weeks after baseline
measure: Fugl-Meyer Assessment - Upper Extremity -Stroke Group - 4 weeks after baseline
timeFrame: Baseline, 4 weeks after baseline
measure: Motor Activity Log -Stroke Group - Baseline
timeFrame: Baseline, 4 weeks after baseline
measure: Motor Activity Log -Stroke Group - 4 weeks after baseline
timeFrame: Baseline, 4 weeks after baseline
measure: Range of Motion -Stroke Group - Baseline
timeFrame: Baseline, 4 weeks after baseline
measure: Range of Motion -Stroke Group - 4 weeks after baseline
timeFrame: Baseline, 4 weeks after baseline
measure: Box and Block Test -Stroke Group - Baseline
timeFrame: Baseline, 4 weeks after baseline
measure: Box and Block Test -Stroke Group - 4 weeks after baseline
timeFrame: Baseline, 4 weeks after baseline
measure: Modified Tardieu Scale -Stroke Group - Baseline
timeFrame: Baseline, 4 weeks after baseline
measure: Modified Tardieu Scale -Stroke Group - 4 weeks after baseline
timeFrame: Baseline, 4 weeks after baseline
measure: Semmes-Weinstein monofilament test -Stroke Group - Baseline
timeFrame: Baseline, 4 weeks after baseline
measure: Semmes-Weinstein monofilament test -Stroke Group - 4 weeks after baseline
timeFrame: Baseline, 4 weeks after baseline
measure: System Usability Scale -Stroke Group - 4 weeks after baseline
timeFrame: 4 weeks after baseline
measure: Manual Muscle Testing -Spinal Cord Injury Group - Baseline
timeFrame: Baseline, 4 weeks after baseline
measure: Manual Muscle Testing -Spinal Cord Injury Group - 4 weeks after baseline
timeFrame: Baseline, 4 weeks after baseline
measure: Range of Motion -Spinal Cord Injury Group - Baseline
timeFrame: Baseline, 4 weeks after baseline
measure: Range of Motion -Spinal Cord Injury Group - 4 weeks after baseline
timeFrame: Baseline, 4 weeks after baseline
measure: Functional Independence Measure -Spinal Cord Injury Group - Baseline
timeFrame: Baseline, 4 weeks after baseline
measure: Functional Independence Measure -Spinal Cord Injury Group - 4 weeks after baseline
timeFrame: Baseline, 4 weeks after baseline
measure: Box and Block Test -Spinal Cord Injury Group - Baseline
timeFrame: Baseline, 4 weeks after baseline
measure: Box and Block Test -Spinal Cord Injury Group - 4 weeks after baseline
timeFrame: Baseline, 4 weeks after baseline
measure: WHO Quality of Life-BREF -Spinal Cord Injury Group - Baseline
timeFrame: Baseline, 4 weeks after baseline
measure: WHO Quality of Life-BREF -Spinal Cord Injury Group - 4 weeks after baseline
timeFrame: Baseline, 4 weeks after baseline
measure: Taiwanese Version of Quebec User Evaluation of Satisfaction with Assistive Technology -Spinal Cord Injury Group - 4 weeks after baseline
timeFrame: 4 weeks after baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng-Kung University Hospital
city: Tainan
country: Taiwan
facility: Chi Mei Medical Center
Study officials:
affiliation: National Cheng Kung University
name: Li-Chieh Kuo, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: