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Influence of physiotherapy and Ziclague ® in the standing posture and gait in children with cerebral palsy

Influence of kinesiotherapy to gain orthostasis and gait in cerebral palsy children with spasticity associated with the use of Ziclague ®

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-37ry9f
Enrollment
Unknown
Registered
2020-07-31
Start date
2017-08-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infantile cerebral palsy

Interventions

The physiotherapeutic treatment will be carried out after 15 minutes of the application of Ziclague® (phytomedicine from Essential oil of Alpinia zerumbet - EOAz), time necessary for the absorption of
Biological/vaccine
E02.779

Sponsors

Universidade Tiradentes
Lead Sponsor
Universidade Tiradentes
Collaborator

Eligibility

Age
1 Years to 12 Years

Inclusion criteria

Inclusion criteria: Patients with Spastic Cerebral Palsy; Diparetic or tetraparetic Commitment; Classified by the Modified Ashworth Scale between One and Three grades; Aged between One and Twelve years old.

Exclusion criteria

Exclusion criteria: Children with Hypotension, the medication Ziclague is contraindicated (according to the package insert) to people with blood pressure lower than 100 / 60mmHg; Heart disease, avoid applying medication that has not yet been tested in children with Cerebral Palsy who are cardiac patients; Excessive irritability, hyperactivity, involuntary movements, other syndromes or neurological disorders in addition to cerebral palsy, these kinetic disorders will interfere in the performance of the exercises proposed in the treatment of the study, which may generate false results; That have not been subjected to the application of botulinum toxin, the application of botulinum toxin will promote relaxation by decreasing acetylcholine that directly interferes with the pharmacodynamics of the Ziclague® that presents a therapeutic target to the type L calcium channels and releases the action of acetylcholine in the muscles; Surgery on the spine or hip in the last 6 months, these surgeries in this period contraindicate or induce an unviable physical condition for trunk activities or orthostatic activities that make the protocol proposed by the present project unfeasible; Participants who do not adhere correctly to the treatment, ensuring participation in the treatment sessions and following the guidelines prescribed by the researchers; Who have any health problems that interfere with their motor condition; Who develop an allergic reaction to the drug Ziclague®, after starting treatment.

Design outcomes

Primary

MeasureTime frame
To influence the muscle hypertonia in children with cerebral palsy after Ziclague® application associated to kinesiotherapy.

Secondary

MeasureTime frame
To reduce the severity level of the motor functions, using the Gross Motor Function Classification System (GMFCS);To classify the functionality of the body functions and structures and the tasks performances before and after the treatment, through International Classification of Functionality, Incapacity and Health (ICF);To modulate the muscle hypertonia reducing the score grade of Modified Ashworth Scale;To identify trajectories, velocity, angles, and movement time, discrepancies in movement patterns and cinematic performance through CvMob 3.5 software;To evaluate the postural control through level of trunk control before and after treatment with Segmental Assessment of Trunk Control (SATCo)

Countries

Brazil

Contacts

Public ContactEdna Cândido

Universidade Tiradentes

edna_aragao1@globo.com+55 (79) 9 9131-6322

Outcome results

None listed

Source: REBEC (via WHO ICTRP)