The Effects of Neuromuscular Electrical Stimulation and Leap Motion-Based Exercises on Hand Function Parameters in Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Hand Function
研究概览
简要总结
Cerebral palsy (CP) is a group of disorders resulting from a permanent but non-progressive lesion in the developing brain, which affects the development of movement and posture and may lead to activity limitations. Upper extremity involvement is observed in approximately 60% of children with CP. Abnormal muscle tone, imbalance between agonist and antagonist muscles, spasticity, alignment problems, reduced muscle strength, and impaired motor control are among the upper extremity impairments seen in CP. As a result, hand use is typically affected in a way that negatively influences the performance of daily living activities. Upper extremity functionality and hand use are crucial for participation in daily life and overall quality of life in children with CP.
In addition to conventional rehabilitation methods, advances in technology have introduced various new modalities for upper extremity rehabilitation. The aim of the present project is to investigate the effects of Leap Motion-based exercise intervention and Neuromuscular Electrical Stimulation (NMES) on hand functions in children with spastic CP.
A total of 30 children aged 6-15 years with a diagnosis of spastic CP and distal upper extremity involvement will be included in the study. To evaluate eligibility according to the inclusion criteria, gross motor function level will be assessed using the Gross Motor Function Classification System (GMFCS); hand skills will be assessed using the Manual Ability Classification System (MACS); upper extremity muscle tone will be assessed using the Modified Ashworth Scale (MAS); and passive wrist extension range of motion (ROM) will be measured using an electronic goniometer.
Following eligibility confirmation, baseline assessments will be conducted. At baseline wrist ROM will be measured using an electronic goniometer; selective motor control of the wrist will be assessed using the Selective Control of the Upper Extremity Scale (SCUES); hand functions will be evaluated using the Jebsen-Taylor Hand Function Test; daily hand use will be assessed using the ABILHAND-Kids; and wrist extensor and flexor strength and activation will be evaluated via surface electromyography (sEMG).
All participants will then undergo a 4-week routine conventional exercise program (3 sessions per week, 40 minutes per session). At the end of this 4-week period assessments will be repeated (at week 4). Subsequently, the 30 children with CP will be randomly allocated into two groups: the Leap Motion Control group (n = 15) and the NMES group (n = 15). Both groups will receive an 8-week intervention consisting of 3 sessions per week, each lasting 60 minutes (20 minutes of Leap Motion-based exercises or 20 minutes of NMES application, in addition to 40 minutes of conventional exercises). At the end of the 8-week intervention, all assessments will be repeated ( at week 12).
For statistical analyses, the Statistical Package for the Social Sciences (SPSS) Version 23.0 for Windows will be used.
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
- None
入排标准
- 年龄范围
- 6 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of spastic unilateral or bilateral cerebral palsy based on clinical and MRI findings.
- •Involvement of the distal upper extremity (wrist and/or fingers).
- •Aged between 6 and 15 years.
- •No history of botulinum toxin injection or surgical intervention to the upper extremity within the past 6 months.
- •Gross Motor Function Classification System (GMFCS) levels I-III.
- •Manual Ability Classification System (MACS) levels I-III.
- •Upper extremity spasticity corresponding to 0, 1, or 1+ on the Modified Ashworth Scale (MAS).
- •Passive wrist extension limitation not exceeding 10 degrees.
- •Ability to follow verbal instructions (mental level reported as "normal" or "mild mental retardation" in the medical record).
排除标准
- •Currently participating in a specific hand rehabilitation program.
- •Presence of visual or hearing impairment.
- •History of epilepsy.
- •Presence of chronic, orthopedic, or systemic conditions that may interfere with participation.
- •GMFCS levels IV or V.
- •MACS levels IV or V.
研究组 & 干预措施
Leap Motion Group
Participants in this group will perform upper extremity exercises using the Leap Motion Controller combined with virtual reality-based training, in addition to conventional rehabilitation.
干预措施: Leap Motion-Based Exercise Program (Device)
Leap Motion Group
Participants in this group will perform upper extremity exercises using the Leap Motion Controller combined with virtual reality-based training, in addition to conventional rehabilitation.
干预措施: Conventional Exercise Program (Behavioral)
NMES Group
Participants in this group will receive Neuromuscular Electrical Stimulation (NMES) applied to the wrist extensor muscles, in addition to conventional rehabilitation.
干预措施: NMES (Device)
NMES Group
Participants in this group will receive Neuromuscular Electrical Stimulation (NMES) applied to the wrist extensor muscles, in addition to conventional rehabilitation.
干预措施: Conventional Exercise Program (Behavioral)
结局指标
主要结局
Hand Function
时间窗: Baseline (at week 0), after completion of a 4-week conventional exercise program (at week 4), and after completion of an additional 8-week intervention period (at week 12).
Hand Function will be assessed with Jebsen-Taylor Hand Function Test. JTHFT is a timed, seven-subtest assessment designed to evaluate hand functionality. The test is derived from common daily activities and includes the following tasks: writing a standardized 24-letter sentence, turning five cards, picking up small objects, picking up five beans using a spoon, stacking four checkers on a test board, moving five large empty cans, and moving five full cans. Since the study population includes children who may not yet be literate according to the age criteria, the first subtest (writing a sentence) will be omitted from the evaluation. Each subtest allows a maximum of 120 seconds for successful completion. All subtests are first performed with the non-dominant hand, followed by the dominant hand. For each subtests shorter times indicate better performance. The validity and reliability of the JTHFT in children with cerebral palsy aged 6-18 years have been established by Tofani et al.
次要结局
- Goniometric Assessment(Baseline (at Week 0), after completion of a 4-week conventional exercise program (at Week 4), and after completion of an additional 8-week intervention period (at Week 12).)
- Selective Motor Control(Baseline (at week 0), after completion of a 4-week conventional exercise program (at week 4), and after completion of an additional 8-week intervention period (at week 12).)
- Muscle Activation(Baseline (at week 0), after completion of a 4-week conventional exercise program (at week 4), and after completion of an additional 8-week intervention period (at week 12).)
- Hand Use in Daily Activities(Baseline (at week 0), after completion of a 4-week conventional exercise program (at week 4), and after completion of an additional 8-week intervention period (at week 12).)
研究者
Hande Özlü Erdoğan
PhD Candidate- MSc. Physiotherapist- Principal Investigator
Medipol University