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

February 16, 2026 updated by: Seda AYAZ TAŞ, Abant Izzet Baysal University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
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.
Experimental: 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.
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.
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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Upper Extremity Skill Quality Test
Time Frame: Baseline and Week 8
Assessment of upper limb movement quality and functional performance, including reaching, grasping, release, and coordination during task-oriented activities.
Baseline and Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Box and Block Test
Time Frame: Baseline and Week 8
Assessment of gross manual dexterity by counting the number of blocks transferred from one compartment to another within 60 seconds using the affected hand.
Baseline and Week 8
Grip Strength
Time Frame: Baseline and Week 8
Measurement of maximal voluntary grip strength of the affected hand using a digital hand dynamometer under standardized testing conditions.
Baseline and Week 8
Modified Tardieu Scale
Time Frame: Baseline and Week 8
Evaluation of spasticity severity in affected upper limb muscles by assessing resistance to passive stretch at different velocities using the Modified Tardieu Scale. Modified Tardieu Scale (MTS): We used the Modified Tardieu Scale to assess spasticity. Two scores are recorded: R1 (angle of muscle reaction at fast stretch) and R2 (full passive range of motion at slow stretch), both measured in degrees (approximately 0-180°, depending on the joint). The difference R2-R1 (degrees) reflects the dynamic component of spasticity; a larger R2-R1 indicates greater spasticity/dynamic catch (i.e., worse outcome). In addition, the quality of muscle reaction is graded on an ordinal scale from 0 to 4, where higher scores indicate a stronger/faster catch or clonus
Baseline and Week 8
Joint Range of Motion (Kinovea Motion Analysis)
Time Frame: Baseline and Week 8
Assessment of active joint range of motion of the affected upper extremity, including shoulder external rotation, forearm supination, and wrist extension, measured using video-based motion analysis with Kinovea software.
Baseline and Week 8
Child Hand-use Experience Questionnaire (CHEQ)
Time Frame: Baseline and Week 8
Parent-reported assessment of the child's hand use, efficiency, and experience during bimanual daily activities. Child Hand Skills Questionnaire: The questionnaire includes 21 items assessing hand skill performance in daily activities. Each item is rated on a 3-point scale (1 = very difficult, 2 = difficult, 3 = not difficult); items may be marked not applicable. Total raw score range: 21-63 (higher scores indicate better hand skills / less difficulty).
Baseline and Week 8
Pediatric Evaluation of Disability Inventory (PEDI)
Time Frame: Baseline and Week 8
Evaluation of functional independence and participation in daily activities, including self-care, mobility, and social function, based on caregiver reports. PEDI assesses functional performance in Self-Care, Mobility, and Social Function using three scales: Functional Skills (items scored 0-1), Caregiver Assistance (items scored 0-5), and Modifications. Domain scores are reported as scaled scores ranging from 0 to 100, where 0 indicates low functioning and 100 indicates high functioning; higher scores represent greater functional ability/independence (better outcome)
Baseline and Week 8
Quebec User Evaluation of Satisfaction with Assistive Technology
Time Frame: Week 8
Caregiver-reported satisfaction with the spiral taping systems, including comfort, ease of use, and perceived benefit, measured using the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0). QUEST 2.0 is a 12-item questionnaire assessing satisfaction with an assistive technology device and related services (8 device items and 4 service items). Each item is rated on a 5-point satisfaction scale (1-5), from 1 = not satisfied at all to 5 = very satisfied. Higher scores indicate greater satisfaction (better outcome). Total and subscale scores are typically reported as the mean item score (range 1-5).
Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abant Izzet Baysal University

Investigators

  • Principal Investigator: Özge KARANLIK ÖZCAN, Msc, Abant Izzet Baysal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 15, 2026

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

February 15, 2027

Study Registration Dates

First Submitted

January 24, 2026

First Submitted That Met QC Criteria

February 16, 2026

First Posted (Actual)

February 18, 2026

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 16, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BAIBU-FTR-SAT-13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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