Effects Of Spiral Strapping Systems On Upper Limb Function In Unilateral Spastic Cerebral Palsy

Официальное название

The Effect Of Different Spiral Strapping Systems On Upper Extremity Functionality, Hand Skills, And Grip Strength In Children With Unilateral Spastic Cerebral Palsy

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство TheraTogs® Spiral Strapping System
  Application of the TheraTogs® spiral strapping system to the affected upper extremity using a standardized protocol to support functional alignment and enhance proprioceptive input during upper limb activities.
• Устройство TogRite™ Spiral Strapping System
  Application of the TogRite™ spiral strapping system to the affected upper extremity using a standardized protocol to support functional alignment and enhance proprioceptive input during upper limb activities.
• Поведенческое Upper Limb Rehabilitation and Home Exercise Program
  A structured upper limb rehabilitation program combined with an individualized home exercise program focusing on muscle tone regulation, joint range of motion, hand-arm coordination, grasp and release activities, and functional hand use. The program will be delivered in the clinic twice weekly for eight weeks, with additional home exercises prescribed three times per week for all participants.

Первичные конечные точки

• Upper Extremity Skill Quality Test [Срок оценки: Baseline and Week 8]

Вторичные конечные точки (7)

• Box and Block Test [Срок оценки: Baseline and Week 8]
• Grip Strength [Срок оценки: Baseline and Week 8]
• Modified Tardieu Scale [Срок оценки: Baseline and Week 8]
• Joint Range of Motion (Kinovea Motion Analysis) [Срок оценки: Baseline and Week 8]
• Child Hand-use Experience Questionnaire (CHEQ) [Срок оценки: Baseline and Week 8]
• Pediatric Evaluation of Disability Inventory (PEDI) [Срок оценки: Baseline and Week 8]
• Quebec User Evaluation of Satisfaction with Assistive Technology [Срок оценки: Week 8]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07418710 · BAIBU-FTR-SAT-13

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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