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Functional Exercise Training With Adolescents With Cerebral Palsy

U

University Children's Hospital Basel

Status

Completed

Conditions

Cerebral Palsy

Treatments

Other: functional exercise training
Other: standard therapy / treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT04911309
2020-02827 ks20Klaeusler;

Details and patient eligibility

About

This cross-over study analyzes a novel and inclusive approach in how therapy for adolescents with CP is administered, with the main goal of examining the effects of a functional exercise intervention on motor capability and motor capacity.

It is to investigate the effects of a functional movement-based exercise intervention in a group setting on motor capacity, motor capability and quality of life in adolescents with CP compared to standard therapy.

Full description

Cerebral palsy (CP) is a permanent disorder which affects the development of movement and posture. It causes activity limitation and is oftentimes accompanied by secondary musculoskeletal problems, disturbances of sensation, perception, cognition, communication and behavior.

In regard of the complex interplay between physical restrictions, motor disabilities, sedentary lifestyles and low participation in physical activity, an innovative exercise intervention study for adolescents with CP is intended in order to break the stated vicious cycle. This study aims at providing a novel and inclusive approach in how therapy for adolescents with CP is administered, with the main goal of examining the effects of a functional exercise intervention on motor capability and motor capacity.

Enrollment

12 patients

Sex

All

Ages

12 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of CP.
  • Adolescents between 12 and 18 years of age.
  • Gross Motor Functional Classification System (GMFCS): I-III.
  • Cognitive abilities must include: Ability to actively engage in a training session of 60 min. duration; Ability to verbally or non-verbally communicate pain or discomfort; Ability to attend training, testing and follow-up sessions. All included participants are capable of making decisions on their own and no not show any signs of mental or cognitive limitations.

Exclusion criteria

  • Any surgery or botulinum toxin treatment within 6 months prior to the start of the study or surgery/serial casting / botulinum toxin injection scheduled during the study period. Other medications can be continued as prescribed by the participants' physician.
  • Known cardiovascular or pulmonary diseases that have not received medical clearance to participate in the physical exercise intervention.
  • Uncontrolled seizures or epilepsy

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

12 participants in 2 patient groups

Group 1: 12 weeks functional exercise training followed by standard therapy
Active Comparator group
Description:
12 weeks functional exercise training twice per week, each session lasting 60 min, additionally to standard therapy. Training sessions will be performed in a group-setting consisting of minimum 4 and maximum 8 participants and coached by experienced sport scientists with the supervision of a medical doctor. The exercises will be individually pants and constantly recorded in order to allow a progression over the course of the 12 week-period. The motor tasks and exercises will be tailored to individual capacity by experienced and trained sport scientists and coaches, therefore insuring the participants' safety and a continuous and progressive monitoring of training load. After 12 weeks the groups will switch the intervention method. Group 1 will therefore reassume their standard therapy for 12 weeks.
Treatment:
Other: functional exercise training
Other: standard therapy / treatment
Group 2: 12 weeks standard therapy / treatment followed by 12 weeks functional exercise training
Active Comparator group
Description:
12 weeks standard therapy / treatment; the standard therapy group receives no additional exercise sessions. After 12 weeks the groups will switch the intervention method. Group 1 will therefore reassume their standard therapy for 12 weeks. After 12 weeks the groups will switch the intervention method. Group 2 will perform the same intervention which Group 1 received over the first course of 12 weeks.
Treatment:
Other: functional exercise training
Other: standard therapy / treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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