Cerebral Palsy (CP), Hand Grip Strength, Spasticity, Upper Extremity Function
Conditions
Keywords
cerebral palsy, upper extremity function, spasticity, hand grip strength, orthoses, hand skill
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.
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.
Interventions
DEVICETheraTogs® 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.
DEVICETogRite™ 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.
BEHAVIORALUpper 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.
Sponsors
Abant Izzet Baysal University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
4 Years to 15 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Upper Extremity Skill Quality Test | Baseline and Week 8 | Assessment of upper limb movement quality and functional performance, including reaching, grasping, release, and coordination during task-oriented activities. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Box and Block Test | 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. |
| Grip Strength | Baseline and Week 8 | Measurement of maximal voluntary grip strength of the affected hand using a digital hand dynamometer under standardized testing conditions. |
| Modified Tardieu Scale | 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 |
| Joint Range of Motion (Kinovea Motion Analysis) | 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. |
| Child Hand-use Experience Questionnaire (CHEQ) | 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). |
| Pediatric Evaluation of Disability Inventory (PEDI) | 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) |
| Quebec User Evaluation of Satisfaction with Assistive Technology | 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). |
Contacts
CONTACTOzge KARANLIK OZCAN, Msc
CONTACTSeda AYAZ TAS, PhD
PRINCIPAL_INVESTIGATORÖzge KARANLIK ÖZCAN, Msc
Abant Izzet Baysal University
Outcome results
None listed