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

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
High Intensity Interval Training
Progressive Resistance Training
Sponsored by
Svehlik Martin, MD PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral Palsy, Muscle structure, Strength training

Eligibility Criteria

8 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • LKH Graz - Department of Pediatric and Adolescent Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Progressive Resistance Training

High Intensity Interval Training

Arm Description

The key for the PRT is the timely progression of load, based on the child's individual level of strength, which ensures progressive overload. Every training session will consist of a warm up, progressive resistance exercises and a cool down period. During warm up and cool down periods.These exercises will be the same for both training groups. The strength training exercises have been chosen to strengthen the main lower extremity muscle groups which are important for the gait: sit-to-stand, lateral step-ups, the half knee rise, heel-rises and bridging. All these exercises are performed loaded according to the individual level. Three sets of 8 to 10 repetitions of each exercise will be practiced on 3 non-consecutive days with moderate velocity.

The High Intensity Circuit Training is a sub form of High Intensity Interval Training. The key feature is the very little rest between the exercises which causes a consistent elevation of the participant's heart rate and a short duration of the whole exercise session. Every training session consists of a warm-up, a circuit of 5 exercises (the same as these in the PRT group) and a cool-down period. The children will be asked to train 3 times a week on non-consecutive days and to perform 3 sets. Exercise workload is controlled by determination of time intervals (30 seconds). The children will be instructed to perform as many repetitions as possible during the exercise interval and to keep the rest between the exercises short (it must not exceed 30 seconds).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Change in Range of Motion measurements (Goniometer)
Range of Motion measurements for both lower limbs.
Change in Spasticity measurements (Modified Ashworth Scale)
Spasticity measurements for both lower limbs.
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.
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.
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.
Change in hand held dynamometer muscle strength measurements
Hand-held dynamometry (HHD) is used to quantify subjects' isometric muscle force production.
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.
Change in metabolomics data
A metabolic profile will provide detailed information on the change in energy metabolism.
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)
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.

Full Information

First Posted
December 10, 2014
Last Updated
December 21, 2017
Sponsor
Svehlik Martin, MD PhD
Collaborators
University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT02319122
Brief Title
A Prospective Study of Two Home Based Muscle Strengthening Programs for Children With Cerebral Palsy
Official Title
A Prospective Study of Two Home Based Muscle Strengthening Programs for Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
July 14, 2017 (Actual)
Study Completion Date
July 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Svehlik Martin, MD PhD
Collaborators
University of Graz

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Cerebral Palsy, Muscle structure, Strength training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Progressive Resistance Training
Arm Type
Other
Arm Description
The key for the PRT is the timely progression of load, based on the child's individual level of strength, which ensures progressive overload. Every training session will consist of a warm up, progressive resistance exercises and a cool down period. During warm up and cool down periods.These exercises will be the same for both training groups. The strength training exercises have been chosen to strengthen the main lower extremity muscle groups which are important for the gait: sit-to-stand, lateral step-ups, the half knee rise, heel-rises and bridging. All these exercises are performed loaded according to the individual level. Three sets of 8 to 10 repetitions of each exercise will be practiced on 3 non-consecutive days with moderate velocity.
Arm Title
High Intensity Interval Training
Arm Type
Other
Arm Description
The High Intensity Circuit Training is a sub form of High Intensity Interval Training. The key feature is the very little rest between the exercises which causes a consistent elevation of the participant's heart rate and a short duration of the whole exercise session. Every training session consists of a warm-up, a circuit of 5 exercises (the same as these in the PRT group) and a cool-down period. The children will be asked to train 3 times a week on non-consecutive days and to perform 3 sets. Exercise workload is controlled by determination of time intervals (30 seconds). The children will be instructed to perform as many repetitions as possible during the exercise interval and to keep the rest between the exercises short (it must not exceed 30 seconds).
Intervention Type
Other
Intervention Name(s)
High Intensity Interval Training
Other Intervention Name(s)
HIIT
Intervention Description
See arm description
Intervention Type
Other
Intervention Name(s)
Progressive Resistance Training
Other Intervention Name(s)
PRT
Intervention Description
See arm description
Primary Outcome Measure Information:
Title
Change in time for 6 minute Walk Test
Description
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.
Time Frame
between baseline and 2 months later (end of intervention)
Secondary Outcome Measure Information:
Title
Change in time for Muscle Power Sprint Test
Description
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.
Time Frame
between baseline and 2 months later (end of intervention)
Title
Change in Range of Motion measurements (Goniometer)
Description
Range of Motion measurements for both lower limbs.
Time Frame
between baseline and 2 months later (end of intervention)
Title
Change in Spasticity measurements (Modified Ashworth Scale)
Description
Spasticity measurements for both lower limbs.
Time Frame
between baseline and 2 months later (end of intervention)
Title
Change in time for Timed Up and Go Test
Description
The test requires the children to rise from an armchair stand momentarily, walk 3 meters, return to the same seat and sit down again.
Time Frame
between baseline and 2 months later (end of intervention)
Title
Change in time for Timed Stair Test
Description
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.
Time Frame
between baseline and 2 months later (end of intervention)
Title
Change in Energy Expenditure Index
Description
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.
Time Frame
between baseline and 2 months later (end of intervention)
Title
Change in hand held dynamometer muscle strength measurements
Description
Hand-held dynamometry (HHD) is used to quantify subjects' isometric muscle force production.
Time Frame
between baseline and 2 months later (end of intervention)
Title
Change in Results of Dynamometry, Ultrasound imaging, Electromyography - Analysis of the muscle-tendon unit morphology and physiology measurements of the calf muscles
Description
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.
Time Frame
between baseline and 2 months later (end of intervention)
Title
Change in metabolomics data
Description
A metabolic profile will provide detailed information on the change in energy metabolism.
Time Frame
between baseline and 2 months later (end of intervention)
Title
Change in results of Pediatric Outcome Data Collection Instrument (PODCI) and Activity Scale for kids performance version (ASKp) questionnaires
Description
Questionnaires measuring the childrens participation and activities of daily living (ADLs)
Time Frame
between baseline and 2 months later (end of intervention)
Title
Change of 3D Gait Analysis data
Description
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.
Time Frame
between baseline and 2 months later (end of intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Svehlik, MD, PhD
Organizational Affiliation
LKH-Univ.Klinikum Graz
Official's Role
Principal Investigator
Facility Information:
Facility Name
LKH Graz - Department of Pediatric and Adolescent Surgery
City
Graz
State/Province
Styria
ZIP/Postal Code
8036
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
18842125
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.
Results Reference
background
PubMed Identifier
19620931
Citation
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.
Results Reference
background
PubMed Identifier
24124631
Citation
Romero-Arenas S, Martinez-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.
Results Reference
background
PubMed Identifier
23823710
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.
Results Reference
background
PubMed Identifier
24707476
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.
Results Reference
background
PubMed Identifier
8245196
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. doi: 10.1097/01241398-199311000-00007.
Results Reference
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PubMed Identifier
19118156
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.
Results Reference
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PubMed Identifier
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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. doi: 10.1017/s0012162205001027.
Results Reference
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PubMed Identifier
33487525
Citation
Schranz C, Kruse A, Tilp M, Svehlik M. Is there a relationship between muscle-tendon properties and a variety of functional tasks in children with spastic cerebral palsy? Gait Posture. 2021 Mar;85:14-19. doi: 10.1016/j.gaitpost.2021.01.009. Epub 2021 Jan 14.
Results Reference
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PubMed Identifier
30473019
Citation
Schranz C, Kruse A, Belohlavek T, Steinwender G, Tilp M, Pieber T, Svehlik M. Does Home-Based Progressive Resistance or High-Intensity Circuit Training Improve Strength, Function, Activity or Participation in Children With Cerebral Palsy? Arch Phys Med Rehabil. 2018 Dec;99(12):2457-2464.e4. doi: 10.1016/j.apmr.2018.06.010. Epub 2018 Jul 4.
Results Reference
derived

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

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