NCT07418710

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Abant Izzet Baysal University · Academic / Other
• Sex: All
• Age: 4 Years – 15 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cerebral Palsy (CP)
• Hand Grip Strength
• Upper Extremity Function
• Spasticity

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.
BEHAVIORAL	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.

Timeline

• Start date: 2026-02-15
• Primary completion: 2026-09-15
• Completion: 2027-02-15
• First posted: 2026-02-18
• Last updated: 2026-02-18