Functional Exercise Training With Adolescents With Cerebral Palsy

NCT04911309 | Completed

• 1 other identifier: 2020-02827; ks20Klaeusler
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

adolescents with cerebral palsy; functional exercise intervention; motor capability; motor capacity; gross motor function measure (GMFM-66)

Outcome Measures

Primary Outcomes (1)

• Change in Gross Motor Function Measure-66 (GMFM-66)

  assessment tool designed to measure changes in gross motor function over time in children and adolescents with CP. The test consist of the following five dimensions which span the spectrum of gross motor activities: a) lying and rolling; b) sitting; c) crawling and kneeling; d) standing; e) walking, running and jumping. Scores range from 0-3, higher scores denote better performance

  at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)

Secondary Outcomes (19)

• Change in height of participants

  at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)

• Change in body composition

  at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)

• Change in clinical assessment

  at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)

• Change in muscle strength test (scale: 0-5)

  at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)

• Change in arterial stiffness

  at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)

Study Arms (2)

Group 1: 12 weeks functional exercise training followed by standard therapy

ACTIVE COMPARATOR

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.

Other: functional exercise training; Other: standard therapy / treatment

Group 2: 12 weeks standard therapy / treatment followed by 12 weeks functional exercise training

ACTIVE COMPARATOR

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.

Other: functional exercise training; Other: standard therapy / treatment

Interventions

functional exercise training OTHER

12 weeks functional exercise training twice per week, each session lasting 60 min

Group 1: 12 weeks functional exercise training followed by standard therapy; Group 2: 12 weeks standard therapy / treatment followed by 12 weeks functional exercise training

standard therapy / treatment OTHER

12 weeks standard therapy / treatment

Group 1: 12 weeks functional exercise training followed by standard therapy; Group 2: 12 weeks standard therapy / treatment followed by 12 weeks functional exercise training

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Children's Hospital Basel: lead
• Béatrice Ederer-Weber Stiftung: collaborator
• Schweizerische Stiftung für das cerebral gelähmte Kind: collaborator

Study Sites (1)

University Children's Hospital Basel

Basel, 4056, Switzerland

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Standard of Care; Therapeutics

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Elke Viehweger, Prof. Dr. med.

  Childrens University Hospital Basel (UKBB)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is designed as a two-armed crossover intervention study with two intervention phases lasting 12 weeks each and three measurement points.

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 3, 2021
• Study Start: March 25, 2021
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2022
• Last Updated: January 18, 2023

Record last verified: 2023-01

Locations

CH (1)