Clinical trial NCT06069765: Trunk and Upper Extremities Program Effect in Decreasing Compensation Patterns in Unilateral Cerebral Palsy Children
Official title: Trunk and Upper Extremities Program Effect in Decreasing Compensation Patterns in Unilateral Cerebral Palsy Children: Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cerebral Palsy Infantile
Chronic Pain
Upper Extremity Dysfunction
Keywords: compensation patterns
unilateral cerebral palsy
Lead sponsor: Fundacio Aspace Catalunya
Sponsor class: OTHER
Collaborators: name: Universitat Internacional de Catalunya
First posted: 2023-10-06
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to test the effectiveness of a trunk and upper extremities exercise program. The main questions it aims to answer are:

Whether the program decreases compensation patterns in unilateral cerebral palsy children Whether the program decreases pain in unilateral cerebral palsy children Whether the program improves bimanual ability in unilateral cerebral palsy children Participants will undertake and 8-week program exercise at home If there is a comparison group: Researchers will compare with the control group to see if this program decreases compensation patterns.

Detailed description: Children in control group will continue with their daily activities. Children in experimental group, apart from their daily activities, will undertake an 8-week program exercise at home for strengthening the trunk and the proximal part of both upper extremities. It contains 3 progressions that can be applied if needed.

Eligibility criteria: Inclusion Criteria:

* Unilateral cerebral palsy diagnostic
* Level I or II of the Manual Ability Scale Classification

Exclusion Criteria:

* Have received any intervention with botulinum toxin or shock waves in the previous six months or have them scheduled during the intervention
* Are undergoing treatment with intensive therapies.
* To have known alteration in the hips
* Have very serious attention or comprehension difficulties that prevent them from following instructions.
* Suffer uncontrolled epilepsies
* Suffer from severe visual problems.

Primary outcomes:
measure: Rate of variance of the Compensation patterns
timeFrame: 8 weeks
Secondary outcomes:
measure: Intensity of pain
timeFrame: 8 weeks
measure: Location of pain
timeFrame: 8 weeks
measure: Bimanual ability
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Aspace Catalunya
name: Tamara Biedermann
role: STUDY_CHAIR
References:
citation: Abd-Elfattah HM, Aly SM. Effect of Core Stability Exercises on Hand Functions in Children With Hemiplegic Cerebral Palsy. Ann Rehabil Med. 2021 Feb;45(1):71-78. doi: 10.5535/arm.20124. Epub 2021 Feb 9.
citation: Mckinnon CT, Meehan EM, Harvey AR, Antolovich GC, Morgan PE. Prevalence and characteristics of pain in children and young adults with cerebral palsy: a systematic review. Dev Med Child Neurol. 2019 Mar;61(3):305-314. doi: 10.1111/dmcn.14111. Epub 2018 Dec 3.
citation: Brochard S, Lempereur M, Mao L, Remy-Neris O. The role of the scapulo-thoracic and gleno-humeral joints in upper-limb motion in children with hemiplegic cerebral palsy. Clin Biomech (Bristol). 2012 Aug;27(7):652-60. doi: 10.1016/j.clinbiomech.2012.04.001. Epub 2012 May 2.
citation: Francisco-Martinez C, Prado-Olivarez J, Padilla-Medina JA, Diaz-Carmona J, Perez-Pinal FJ, Barranco-Gutierrez AI, Martinez-Nolasco JJ. Upper Limb Movement Measurement Systems for Cerebral Palsy: A Systematic Literature Review. Sensors (Basel). 2021 Nov 26;21(23):7884. doi: 10.3390/s21237884.
citation: Jackman M, Sakzewski L, Morgan C, Boyd RN, Brennan SE, Langdon K, Toovey RAM, Greaves S, Thorley M, Novak I. Interventions to improve physical function for children and young people with cerebral palsy: international clinical practice guideline. Dev Med Child Neurol. 2022 May;64(5):536-549. doi: 10.1111/dmcn.15055. Epub 2021 Sep 21.
citation: Novak I. Evidence-based diagnosis, health care, and rehabilitation for children with cerebral palsy. J Child Neurol. 2014 Aug;29(8):1141-56. doi: 10.1177/0883073814535503. Epub 2014 Jun 22.