Evaluating Functional Outcomes of 3D-Printed Splints in Post-Stroke Upper Limb Recovery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Wolf Motor Function Test (WMFT)
研究概览
简要总结
This study aims to evaluate the upper limb motor recovery using a 3D-printed dynamic orthosis compared to a conventional one as part of a rehabilitation program in individuals with chronic stroke.
The main question it seeks to answer:
Which type of dynamic splint (3D-printed or traditional), combined with the task-oriented therapy program, leads to greater improvement in affected upper-limb function, patient satisfaction, and usability in stroke patients? Researchers will compare these two types of dynamic splints.
Participants will:
Receive 20 sessions of task-oriented therapy combined with either a 3D-printed dynamic splint or a traditional dynamic splint.
Visit the clinic five times a week for a period of four weeks. Undergo assessments before and after the 4-week program.
详细描述
Background: After a stroke, intensive motor rehabilitation is essential to improve upper limb function and independence. 3D-printed dynamic splints offer precise joint alignment, adjustable resistance, and enhanced comfort, facilitating repetitive, task-oriented practice and promoting neuroplasticity. To date, no studies have directly compared the effectiveness of 3D-printed dynamic splints with conventional dynamic splints combined with task-oriented therapy for improving upper limb function after stroke. Objectives: To evaluate the effects of 3D-printed versus conventional dynamic splints, both combined with task-oriented therapy, on upper limb motor recovery and patient satisfaction in chronic stroke patients. Methods: A randomized controlled trial will assign participants to either a 3D-printed splint + task-oriented therapy group or a conventional splint + therapy group. The intervention will last 4 weeks, with five 60-minute sessions per week, and daily splint use for 6 hours.
Inclusion Criteria: Adults ≥18 years with chronic stroke and upper limb hemiparesis, able to understand and follow instructions, MMSE ≥24, mild to moderate upper-limb spasticity, and not participating in other clinical or research studies simultaneously. Exclusion Criteria: Severe spasticity, upper limb deformities or contractures, unilateral neglect, or severe language or cognitive impairments.Outcomes: Primary outcomes: Fugl-Meyer Assessment for Upper Extremity (FMA-UE), Wolf Motor Function Test (WMFT), Box and Block Test (BBT). Secondary outcomes: Motor Activity Log (MAL), Arabic version of Stroke Impact Scale (SIS-16), and Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years old.
- •Chronic stroke
- •Upper limb hemiparalysis
- •Ability to understand and follow orders and able to provide informed consent (Mini-Mental State Exam (MMSE) > 24)
- •Upper-limb mild to moderate spasticity (Modified Ashworth Scale 1+ to 3 at the wrist).
- •Not participating in other clinical or research studies at the same time
排除标准
- •Had deficits in language or cognitive impairments that were likely to interfere with their cooperation in the study
- •Deformity or presented with severe upper-limb contractures
- •Inability to commit to the time requirement of the protocol.
- •Unilateral neglect
结局指标
主要结局
Wolf Motor Function Test (WMFT)
时间窗: at baseline and after intervention (4 weeks)
The WMFT is a standardized assessment used to measure upper extremity motor ability through the performance of 17 tasks that include both functional and strength components. Rated using the 6-point scale ranging from 0 (no attempt) to 5 (normal movement). The total performance time and quality of movement are recorded, with lower scores indicating lower levels of functioning.
Fugl-Meyer Assessment Scale for Upper Extremity (FMA-UE)
时间窗: at baseline and after intervention (4 weeks)
The FMA-UE is a comprehensive quantitative measure designed to evaluate motor function, coordination, and reflex activity of the affected upper limb following stroke. It uses a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully), with a maximum score of 66 points for the upper extremity. It is considered the gold standard for assessment of upper limb motor recovery.
Box and Block Test (BBT)
时间窗: at baseline and after intervention (4 weeks)
The BBT is a validated measure of gross manual dexterity that evaluates how many 1-inch wooden blocks a participant can transfer from one compartment to another within 60 seconds using one hand. The apparatus consists of a wooden box divided into two equal sections containing 150 small cubes. The test begins with the unaffected upper limb to allow practice and establish a baseline performance. Participants are then instructed to move as many blocks as possible, one at a time, over the partition within the time limit. The score is defined as the total number of blocks successfully transferred within 60 seconds.
次要结局
- Motor Activity Log (MAL)(at baseline and after intervention (4 weeks))
- Arabic Version of Stroke Impact Scale (SIS-16)(at baseline and after intervention (4 weeks))
- Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)(Each session (5 times per week))
研究者
Zainab Saud Alshammari
Physical therapist
King Saud University