The Effect Of Different Spiral Strapping Systems On Upper Extremity Functionality, Hand Skills, And Grip Strength In Children With Unilateral Spastic Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 27
- 主要终点
- Upper Extremity Skill Quality Test
研究概览
简要总结
The purpose of this clinical study is to learn whether two different spiral strapping systems can improve arm and hand use in children with unilateral spastic cerebral palsy. These strapping systems are used to support the arm in a more functional position and to help children control their movements during daily activities.
This study aims to answer the following main questions:
Does spiral strapping help children use their arm and hand more effectively in daily activities?
Does spiral strapping improve hand skills and grip strength?
Is there a difference in effect between the two spiral strapping systems?
To answer these questions, researchers will divide participants into three groups. One group will receive a standard rehabilitation program plus TheraTogs® spiral strapping. A second group will receive the same rehabilitation program plus TogRite™ spiral strapping. The third group will receive the rehabilitation program only.
Participants will:
Take part in rehabilitation sessions twice a week for eight weeks.
Use spiral strapping during some sessions, depending on their group.
Complete arm and hand assessments at the beginning and at the end of the study.
The results of this study may help develop simple and practical rehabilitation approaches that support children with cerebral palsy in becoming more independent in daily life.
详细描述
Children with unilateral spastic cerebral palsy frequently present with impaired upper limb function, reduced hand dexterity, and decreased grip strength, which substantially limit independence and participation in daily activities. Increased spasticity, altered muscle activation patterns, and impaired sensorimotor integration contribute to abnormal upper limb postures and inefficient movement strategies. Interventions that provide sustained low-intensity mechanical support and enhanced proprioceptive input may facilitate functional alignment and motor control.
The aim of this study is to investigate and compare the effects of two different spiral strapping systems, TheraTogs® and TogRite™, when applied in conjunction with a structured upper limb rehabilit
ation program, on upper limb function in children with unilateral spastic cerebral palsy. This randomized, parallel-group clinical trial will include three groups: rehabilitation combined with TheraTogs® spiral strapping, rehabilitation combined with TogRite™ spiral strapping, and rehabilitation alone as a control condition. The intervention period will last eight weeks.
Primary outcomes will include upper limb movement quality and functional performance. Secondary outcomes will assess hand dexterity, grip strength, spasticity severity, joint range of motion, motor performance, daily activity participation, and user satisfaction with the strapping systems. Assessments will be conducted at baseline and immediately after the intervention period using validated clinical and functional outcome measures.
This study is expected to provide the first controlled clinical evidence regarding the comparative effectiveness of different spiral strapping systems for upper limb rehabilitation in children with unilateral spastic cerebral palsy. The findings may contribute to the development of low-cost, non-invasive, and clinically applicable adjunctive rehabilitation strategies aimed at improving upper limb function and functional independence in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of unilateral spastic cerebral palsy
- •Age between 4 and 15 years
- •Manual Ability Classification System (MACS) levels I-III
- •Presence of spasticity graded as 1, 1+, or 2 on the Modified Ashworth Scale in at least two of the following upper limb muscle groups: shoulder internal rotators, elbow flexors, forearm pronators, wrist flexors, finger flexors, or thumb adductors
- •Communication Function Classification System (CFCS) levels I-II
- •Gross Motor Function Classification System (GMFCS) levels I-III
- •Ability to actively participate in upper limb rehabilitation interventions
- •Written informed consent provided by parents or legal guardians
排除标准
- •Upper limb botulinum toxin injection or upper limb surgery within the last 6 months
- •Presence of fixed contractures in the upper limb joints that may interfere with assessment or intervention protocols
- •Severe behavioral or communication problems that would prevent participation in the study procedures
- •Uncontrolled or treatment-resistant epilepsy
研究组 & 干预措施
Rehabilitation + TheraTogs® Spiral Strapping System
articipants in this group will receive a structured upper limb rehabilitation program combined with TheraTogs® spiral strapping applied to the affected upper extremity. Rehabilitation will include task-oriented exercises, strength and flexibility training, and functional movement practice. TheraTogs® spiral taping will be applied according to a standardized protocol and maintained during therapy sessions throughout the eight-week intervention period.
干预措施: TheraTogs® Spiral Strapping System (Device)
Rehabilitation + TheraTogs® Spiral Strapping System
articipants in this group will receive a structured upper limb rehabilitation program combined with TheraTogs® spiral strapping applied to the affected upper extremity. Rehabilitation will include task-oriented exercises, strength and flexibility training, and functional movement practice. TheraTogs® spiral taping will be applied according to a standardized protocol and maintained during therapy sessions throughout the eight-week intervention period.
干预措施: Upper Limb Rehabilitation and Home Exercise Program (Behavioral)
Rehabilitation + TogRite™ Spiral Strapping System
Participants in this group will receive the same structured upper limb rehabilitation program combined with TogRite™ spiral strapping applied to the affected upper extremity. Rehabilitation content will match that of Arm 1. TogRite™ spiral taping will be applied according to a standardized protocol and maintained during therapy sessions throughout the eight-week intervention period.
干预措施: TogRite™ Spiral Strapping System (Device)
Rehabilitation + TogRite™ Spiral Strapping System
Participants in this group will receive the same structured upper limb rehabilitation program combined with TogRite™ spiral strapping applied to the affected upper extremity. Rehabilitation content will match that of Arm 1. TogRite™ spiral taping will be applied according to a standardized protocol and maintained during therapy sessions throughout the eight-week intervention period.
干预措施: Upper Limb Rehabilitation and Home Exercise Program (Behavioral)
Rehabilitation Only
Participants in this group will receive the structured upper limb rehabilitation program alone, without any spiral taping. The rehabilitation program will include task-oriented exercises, strength and flexibility training, and functional movement practice, delivered with the same frequency and duration as in the experimental arms over eight weeks.
干预措施: Upper Limb Rehabilitation and Home Exercise Program (Behavioral)
结局指标
主要结局
Upper Extremity Skill Quality Test
时间窗: Baseline and Week 8
Assessment of upper limb movement quality and functional performance, including reaching, grasping, release, and coordination during task-oriented activities.
次要结局
- Box and Block Test(Baseline and Week 8)
- Grip Strength(Baseline and Week 8)
- Modified Tardieu Scale(Baseline and Week 8)
- Joint Range of Motion (Kinovea Motion Analysis)(Baseline and Week 8)
- Child Hand-use Experience Questionnaire (CHEQ)(Baseline and Week 8)
- Pediatric Evaluation of Disability Inventory (PEDI)(Baseline and Week 8)
- Quebec User Evaluation of Satisfaction with Assistive Technology(Week 8)
研究者
Seda AYAZ TAŞ
Assistant Professor
Abant Izzet Baysal University