Cerebral Palsy (CP)NCT07418710
Effects Of Spiral Strapping Systems On Upper Limb Function In Unilateral Spastic Cerebral Palsy
A study testing TheraTogs® Spiral Strapping System, TogRite™ Spiral Strapping System and Upper Limb Rehabilitation and Home Exercise Program in people with Cerebral Palsy (CP) and Hand Grip Strength, run by Abant Izzet Baysal University.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 15 years
- Conditions the study is for
- Cerebral Palsy (CP), Hand Grip Strength, Upper Extremity Function
- What is being tested?
- TheraTogs® Spiral Strapping System, TogRite™ Spiral Strapping System and Upper Limb Rehabilitation and Home Exercise Program
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2026to 15 Feb 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Seda AYAZ TAS, PhD contact
About this study
Official title: 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:
Read more
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.
Read the 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.
- Being tested
- TheraTogs® Spiral Strapping System, TogRite™ Spiral Strapping System, Upper Limb Rehabilitation and Home Exercise Program
- Keywords
- cerebral palsy, upper extremity function, spasticity, hand grip strength, orthoses, hand skill
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheraTogs® Spiral Strapping SystemDevice
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.
TogRite™ Spiral Strapping SystemDevice
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.
Upper Limb Rehabilitation and Home Exercise ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Upper Limb Rehabilitation and Home Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Extremity Skill Quality Test
Assessment of upper limb movement quality and functional performance, including reaching, grasping, release, and coordination during task-oriented activities.
Measured: Baseline and Week 8
Secondary outcomes (7)
Box and Block Test
Assessment of gross manual dexterity by counting the number of blocks transferred from one compartment to another within 60 seconds using the affected hand.
Measured: Baseline and Week 8
Grip Strength
Measurement of maximal voluntary grip strength of the affected hand using a digital hand dynamometer under standardized testing conditions.
Measured: Baseline and Week 8
Modified Tardieu Scale
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
Measured: Baseline and Week 8
Joint Range of Motion (Kinovea Motion Analysis)
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.
Measured: Baseline and Week 8
Child Hand-use Experience Questionnaire (CHEQ)
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).
Measured: Baseline and Week 8
Pediatric Evaluation of Disability Inventory (PEDI)
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)
Measured: Baseline and Week 8
Quebec User Evaluation of Satisfaction with Assistive Technology
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).
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start15 Feb 2026 (estimated)
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda AYAZ TAŞ, Abant Izzet Baysal University
- Investigators
- Özge KARANLIK ÖZCAN, Msc, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07418710
- Sponsor's protocol ID
- BAIBU-FTR-SAT-13
- Status last verified
- Feb 2026
- First submitted
- 24 Jan 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No