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

NCT ID: NCT02319122

Last Updated: 2017-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-07-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cerebral Palsy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Cerebral Palsy Muscle structure Strength training

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Progressive Resistance Training

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.

Group Type OTHER

Progressive Resistance Training

Intervention Type OTHER

See arm description

High Intensity Interval Training

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).

Group Type OTHER

High Intensity Interval Training

Intervention Type OTHER

See arm description

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

High Intensity Interval Training

See arm description

Intervention Type OTHER

Progressive Resistance Training

See arm description

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

HIIT PRT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

8 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Graz

OTHER

Sponsor Role collaborator

Svehlik Martin, MD PhD

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Svehlik Martin, MD PhD

Senior surgeon

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Martin Svehlik, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

LKH-Univ.Klinikum Graz

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

LKH Graz - Department of Pediatric and Adolescent Surgery

Graz, Styria, Austria

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 18842125 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19620931 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24124631 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23823710 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24707476 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8245196 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19118156 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16108451 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33487525 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30473019 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

26-526 ex 13/14

Identifier Type: -

Identifier Source: org_study_id