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

NCT07418710 | Not Yet Recruiting DMC

• 1 other identifier: BAIBU-FTR-SAT-13
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Keywords

cerebral palsy; upper extremity function; spasticity; hand grip strength; orthoses; hand skill

Outcome Measures

Primary Outcomes (1)

• Upper Extremity Skill Quality Test

  Assessment of upper limb movement quality and functional performance, including reaching, grasping, release, and coordination during task-oriented activities.

  Baseline and Week 8

Secondary Outcomes (7)

• 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

Study Arms (3)

Rehabilitation + TheraTogs® Spiral Strapping System

EXPERIMENTAL

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.

Device: TheraTogs® Spiral Strapping System; Behavioral: Upper Limb Rehabilitation and Home Exercise Program

Rehabilitation + TogRite™ Spiral Strapping System

EXPERIMENTAL

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.

Device: TogRite™ Spiral Strapping System; Behavioral: Upper Limb Rehabilitation and Home Exercise Program

Rehabilitation Only

ACTIVE COMPARATOR

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.

Behavioral: Upper Limb Rehabilitation and Home Exercise Program

Interventions

TheraTogs® Spiral Strapping System DEVICE

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.

Rehabilitation + TheraTogs® Spiral Strapping System

TogRite™ Spiral Strapping System DEVICE

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.

Rehabilitation + TogRite™ Spiral Strapping System

Upper Limb Rehabilitation and Home Exercise Program BEHAVIORAL

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.

Rehabilitation + TheraTogs® Spiral Strapping System; Rehabilitation + TogRite™ Spiral Strapping System; Rehabilitation Only

Eligibility Criteria

• Age: 4 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Özge KARANLIK ÖZCAN, Msc

  Abant Izzet Baysal University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ozge KARANLIK OZCAN, Msc

CONTACT

+905379312285; ozgekaranlik@gmail.com

Seda AYAZ TAS, PhD

CONTACT

ptsedaayaztas@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study is designed as a controlled, parallel-group interventional clinical study. Participants will be assigned to one of three parallel groups: a structured upper limb rehabilitation program combined with TheraTogs® spiral strapping, the same rehabilitation program combined with TogRite™ spiral strapping, or the rehabilitation program alone as the control condition. The intervention will last eight weeks, and outcomes will be assessed at baseline and at the end of the intervention period. The study will be conducted using an open-label design, with no crossover between groups.

Study Record Dates

• First Submitted: January 24, 2026
• First Posted: February 18, 2026
• Study Start: February 15, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): February 15, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share