A Prospective Study of Two Home Based Muscle Strengthening Programs for Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

A Prospective Study of Two Home Based Muscle Strengthening Programs for Children With Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02319122
• Other study ID #: 26-526 ex 13/14
• Status: Completed
• Phase: N/A
• First received: December 10, 2014
• Last updated: December 21, 2017
• Start date: January 2015
• Est. completion date: July 14, 2017

Study information

• Verified date: December 2017
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this randomized, stratified, single-blinded study is to compare two home based strength-training protocols (High Intensity Interval Training and Progressive Resistance Training) and their effects on muscle strength, gait and aerobic and anaerobic capacity in children with cerebral palsy.

Description:

Cerebral palsy is a common neuro-developmental disorder. Among other signs of upper motor neuron syndrome, walking pathologies and muscle weakness are leading signs of disability in children with cerebral palsy. Moreover, the gradual decline in muscle strength is part of the aging process and can be particularly devastating for people with motor disabilities. Therefore muscle-strengthening programs are indicated for children with cerebral palsy. There is evidence that lower extremity muscle strength can be increased by Progressive Resistance Training (PRT) in children with cerebral palsy. However, PRT is time consuming and therefore not always feasible for children with neurologic disorders. Moreover, it does not influence the anaerobic capacity needed for everyday activities in children. High Intensity Interval Training (HIIT) is a time efficient method, which increases both aerobic and anaerobic capacities. The aim of this randomized, stratified, single-blinded study is to compare two home based strength-training protocols (HIIT and PRT) and their effects on muscle strength, gait and aerobic and anaerobic capacity in children with cerebral palsy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 14, 2017
• Est. primary completion date: July 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 16 Years

Eligibility

Inclusion Criteria:

• Ambulatory children with unilateral or bilateral spastic cerebral palsy

• Age between 8-16 years

• Ability to accept and follow verbal instruction

• Gross Motor Function Classification System (GMFCS) at level I-II

• Willingness to participate

Exclusion Criteria:

• Other than spastic form of cerebral palsy (ataxia, athetoid or dystonic)

• Quadriplegia

• History of orthopaedic surgery in the last 12 months

• History of Botulinum Toxin A application in the last 6 months

• Severe mental retardation

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

Other:
• High Intensity Interval Training
See arm description
• Progressive Resistance Training
See arm description

Locations

Country	Name	City	State
Austria	LKH Graz - Department of Pediatric and Adolescent Surgery	Graz	Styria

Sponsors (2)

Lead Sponsor	Collaborator
Svehlik Martin, MD PhD	University of Graz

Country where clinical trial is conducted

Austria, 

References & Publications (8)

Faigenbaum AD, Kraemer WJ, Blimkie CJ, Jeffreys I, Micheli LJ, Nitka M, Rowland TW. Youth resistance training: updated position statement paper from the national strength and conditioning association. J Strength Cond Res. 2009 Aug;23(5 Suppl):S60-79. doi: 10.1519/JSC.0b013e31819df407. Review. — View Citation

Fukumoto Y, Tateuchi H, Ikezoe T, Tsukagoshi R, Akiyama H, So K, Kuroda Y, Ichihashi N. Effects of high-velocity resistance training on muscle function, muscle properties, and physical performance in individuals with hip osteoarthritis: a randomized controlled trial. Clin Rehabil. 2014 Jan;28(1):48-58. doi: 10.1177/0269215513492161. Epub 2013 Jul 3. — View Citation

Miller MB, Pearcey GE, Cahill F, McCarthy H, Stratton SB, Noftall JC, Buckle S, Basset FA, Sun G, Button DC. The effect of a short-term high-intensity circuit training program on work capacity, body composition, and blood profiles in sedentary obese men: a pilot study. Biomed Res Int. 2014;2014:191797. doi: 10.1155/2014/191797. Epub 2014 Feb 23. — View Citation

Romero-Arenas S, Martínez-Pascual M, Alcaraz PE. Impact of resistance circuit training on neuromuscular, cardiorespiratory and body composition adaptations in the elderly. Aging Dis. 2013 Oct 1;4(5):256-63. doi: 10.14336/AD.2013.0400256. Review. — View Citation

Rose SA, DeLuca PA, Davis RB 3rd, Ounpuu S, Gage JR. Kinematic and kinetic evaluation of the ankle after lengthening of the gastrocnemius fascia in children with cerebral palsy. J Pediatr Orthop. 1993 Nov-Dec;13(6):727-32. — View Citation

Scholtes VA, Dallmeijer AJ, Rameckers EA, Verschuren O, Tempelaars E, Hensen M, Becher JG. Lower limb strength training in children with cerebral palsy--a randomized controlled trial protocol for functional strength training based on progressive resistance exercise principles. BMC Pediatr. 2008 Oct 8;8:41. doi: 10.1186/1471-2431-8-41. — View Citation

Williams EN, Carroll SG, Reddihough DS, Phillips BA, Galea MP. Investigation of the timed 'up & go' test in children. Dev Med Child Neurol. 2005 Aug;47(8):518-24. — View Citation

Zhao H, Ren Y, Wu YN, Liu SQ, Zhang LQ. Ultrasonic evaluations of Achilles tendon mechanical properties poststroke. J Appl Physiol (1985). 2009 Mar;106(3):843-9. doi: 10.1152/japplphysiol.91212.2008. Epub 2008 Dec 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in time for 6 minute Walk Test	The 6 minute walk test is a self-paced, submaximal test that assesses functional capacity for walking a prolonged distance. The distance reached within 6 minutes of walking is evaluated.	between baseline and 2 months later (end of intervention)
Secondary	Change in time for Muscle Power Sprint Test	Short-term muscle power will be measured using the mean power (in watts) derived from the Muscle Power Sprint Test. This test has been shown to be reliable in children with cerebral palsy. For the test, the children are instructed to complete six 15m runs at maximum pace. Between each run, the child is allowed a timed 10 second rest. Mean power output (in watts) is calculated based on the child's body weight and the average time taken to perform the six all-out sprints.	between baseline and 2 months later (end of intervention)
Secondary	Change in Range of Motion measurements (Goniometer)	Range of Motion measurements for both lower limbs.	between baseline and 2 months later (end of intervention)
Secondary	Change in Spasticity measurements (Modified Ashworth Scale)	Spasticity measurements for both lower limbs.	between baseline and 2 months later (end of intervention)
Secondary	Change in time for Timed Up and Go Test	The test requires the children to rise from an armchair stand momentarily, walk 3 meters, return to the same seat and sit down again.	between baseline and 2 months later (end of intervention)
Secondary	Change in time for Timed Stair Test	The Timed Stair Test (TST) assesses the time needed to go up and down stairs. The test is performed on a 4 or 5-step set of stairs, with handrails on both sides.	between baseline and 2 months later (end of intervention)
Secondary	Change in Energy Expenditure Index	Heart rate is an accurate and convenient measure of energy expenditure during submaximal work in normally developing children and in children with cerebral palsy and other developmental disabilities.	between baseline and 2 months later (end of intervention)
Secondary	Change in hand held dynamometer muscle strength measurements	Hand-held dynamometry (HHD) is used to quantify subjects' isometric muscle force production.	between baseline and 2 months later (end of intervention)
Secondary	Change in Results of Dynamometry, Ultrasound imaging, Electromyography - Analysis of the muscle-tendon unit morphology and physiology measurements of the calf muscles	After recording, the ultrasound images will be utilized to determine the muscle belly length, fascicle length, pennation angle and muscle thickness of the GM, muscle and tendon excursion, Achilles tendon length and cross-sectional-area (CSA) to calculate muscle and tendon stiffness and Young's modulus of the tendon.	between baseline and 2 months later (end of intervention)
Secondary	Change in metabolomics data	A metabolic profile will provide detailed information on the change in energy metabolism.	between baseline and 2 months later (end of intervention)
Secondary	Change in results of Pediatric Outcome Data Collection Instrument (PODCI) and Activity Scale for kids performance version (ASKp) questionnaires	Questionnaires measuring the childrens participation and activities of daily living (ADLs)	between baseline and 2 months later (end of intervention)
Secondary	Change of 3D Gait Analysis data	Today three dimensional segment models allow the quantification of segment and joint motions of the lower limbs in the three major planes of movement. In addition to the joint-angle and segment-position information, kinetic parameters such as joint moments and forces can be approximated.	between baseline and 2 months later (end of intervention)