Clinical trial NCT04911309: Functional Exercise Training With Adolescents With Cerebral Palsy
Official title: Functional Exercise Intervention With Adolescents With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: adolescents with cerebral palsy
functional exercise intervention
motor capability
motor capacity
gross motor function measure (GMFM-66)
Lead sponsor: University Children's Hospital Basel
Sponsor class: OTHER
Collaborators: name: Béatrice Ederer-Weber Stiftung
name: Schweizerische Stiftung für das cerebral gelähmte Kind
First posted: 2021-06-03
Enrollment: 12
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study is designed as a two-armed crossover intervention study with two intervention phases lasting 12 weeks each and three measurement points.
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Gross Motor Function Measure-66 (GMFM-66)
timeFrame: at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
Secondary outcomes:
measure: Change in height of participants
timeFrame: at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
measure: Change in body composition
timeFrame: at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
measure: Change in clinical assessment
timeFrame: at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
measure: Change in muscle strength test (scale: 0-5)
timeFrame: at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
measure: Change in arterial stiffness
timeFrame: at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
measure: Change in Six-minute walking test
timeFrame: at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
measure: Change in Handgrip Strength
timeFrame: at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
measure: Change in Bear Hug Carry
timeFrame: at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
measure: Change in Laying on the ground and standing up (burpees)
timeFrame: at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
measure: Change in Repeated Chair Rising Test (Box Squats):
timeFrame: at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
measure: Change in Isometric Mid-thigh pull
timeFrame: at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
measure: Change in Push Ups
timeFrame: at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
measure: Change in Medicine Ball over Bar Lift
timeFrame: at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
measure: Change in Seated sled pull
timeFrame: at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
measure: Change in Maximum Power Output
timeFrame: at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
measure: Change in Accelerometry
timeFrame: at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
measure: Change in instrumented gait analysis: temporospatial parameters
timeFrame: at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
measure: Change in instrumented gait analysis: Movement Analysis Profile (MAP)
timeFrame: at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
measure: Change in instrumented gait analysis: Profile Score (GPS)
timeFrame: at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Children's Hospital Basel
Study officials:
affiliation: Childrens University Hospital Basel (UKBB)
name: Elke Viehweger, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: