Health TrialsbyHealthPanel

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

ConditionsCerebral Palsy (CP)Hand Grip StrengthUpper Extremity FunctionSpasticity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-15
SponsorAbant Izzet Baysal University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

Treatment groups

27 Participants
are divided into 3 treatment groups
Group A: Rehabilitation + TheraTogs® Spiral Strapping SystemExperimental treatment 2 interventions
Group B: Rehabilitation + TogRite™ Spiral Strapping SystemExperimental treatment 2 interventions
Group C: Rehabilitation OnlyActive comparator 1 intervention

Trial outcomes

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.

Time frame
Baseline and Week 8

Secondary outcomes

1

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.

Time frame
Baseline and Week 8
2

Grip Strength

Measurement of maximal voluntary grip strength of the affected hand using a digital hand dynamometer under standardized testing conditions.

Time frame
Baseline and Week 8
3

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

Time frame
Baseline and Week 8
4

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.

Time frame
Baseline and Week 8

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Abant Izzet Baysal University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: