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Stretching in Children and Adolescents With Spastic Cerebral Palsy

Primary Purpose

Cerebral Palsy, Spastic

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Static stretching
Proprioceptive neuromuscular facilitation stretching
Sponsored by
University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cerebral Palsy, Spastic focused on measuring Cerebral palsy, Stretching, Muscle-tendon unit, Spasticity, Gait

Eligibility Criteria

6 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • spastic cerebral palsy
  • ambulatory children and adolescents
  • ability to accept and follow verbal instructions
  • no severe contracture of the calf muscles (max. ankle dorsiflexion >= 0°, with knees extended)
  • classified as GMFCS level I, II, or III
  • aged between 6 and 5 years
  • willingness to participate

Exclusion Criteria:

  • others than spastic forms of cerebral palsy
  • severe mental retardation
  • fixed muscle contractures (ankle equinus deformity = max. ankle dorsiflexion <= 0°, with knees extended)
  • oral anti-spastic and/or muscle relaxation medication in the last 6 months
  • orthopaedic surgery and/or Botulinum toxin type A application in the last 12 months

Sites / Locations

  • Institute of Human Movement Science, Sport and Health; University of Graz

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

Static stretching

Control

Proprioceptive neuromuscular facilitation stretching

Follow-up

Arm Description

An 8-week home-based static stretching training for the calf muscles will be performed by group A. Altogether, 10 stretches are performed per leg 4 times a week.

While group A performs the 8-week static stretching training, group B acts as control group performing its daily life activities as usual.

After group A has finished the 8-week static stretching training, group B starts with the 8-week home-based proprioceptive neuromuscular facilitation stretching training. Altogether, 10 stretches are performed per leg 4 times a week.

While group B performs the 8-week proprioceptive neuromuscular facilitation stretching, group A is in its follow-up period performing its daily life activities as usual.

Outcomes

Primary Outcome Measures

Change in mechano-morphological muscle-tendon properties
Gastrocnemius medialis muscle morphology, muscle stiffness, tendon-aponeurosis length and stiffness, muscle-tendon unit length and stiffness, elongations of the tissues
Change in spasticity/stretch hyperreflexia
Stretch reflex responses assessed by a manually controlled instrumented spasticity assessment
Change in joint range of motion
Ankle joint range of motion (maximal plantarflexion - maximal dorsiflexion)
Change in active moment-angle relationship
Maximum isometric voluntary contractions at specific ankle joint angles (isokinetic dynamometry)

Secondary Outcome Measures

Change in gait characteristics
Gait kinematics of the hip, knee, and ankle joints, gait kinetics (3D motion capture)
Change in self-reported gait, mobility, and functional performance
Gait Outcomes Assessment List (GOAL) questionnaire
Change in maximal isometric muscle strength
Maximal isometric torque production (isokinetic dynamometry)

Full Information

First Posted
September 14, 2020
Last Updated
October 11, 2021
Sponsor
University of Graz
Collaborators
VU University of Amsterdam
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1. Study Identification

Unique Protocol Identification Number
NCT04570358
Brief Title
Stretching in Children and Adolescents With Spastic Cerebral Palsy
Official Title
Stretching in Children With Spastic Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
September 11, 2020 (Actual)
Primary Completion Date
September 23, 2021 (Actual)
Study Completion Date
September 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Graz
Collaborators
VU University of Amsterdam

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary aim of this study is to gain knowledge about both the effects of a single bout of static and proprioceptive neuromuscular facilitation (PNF) stretching and the effects of 8-week static and PNF stretching training on the calf muscle-tendon properties in children with spastic cerebral palsy (SCP). Furthermore, the effects on joint and muscle function, stretch reflexes, gait, and self-reported gait function and functional performance are examined to receive a comprehensive picture of potential changes. Further aims of this study are to identify which stretching technique might be more efficient by comparing the effects of both stretching interventions, and to gain information about the influence of foot flexibility on the stretch achieved by the spastic gastrocnemius muscle.
Detailed Description
Background: Spastic cerebral palsy (SCP) is a non-progressive neuro-muscular disorder in children resulting from an injury in the central nervous system. Individuals with SCP present with impairments such as hyperreflexia, demonstrate impaired motor control and muscle growth. Manual stretching is an important approach in the physical therapy of individuals with SCP used to increase muscle extensibility and length, decrease muscle stiffness, and to improve functional abilities. However, there are only a few studies that have examined its acute and long-term effects in children with SCP and it is still not clear, if it may lead to the expected changes, and which method might be the most-effective one. Besides static stretching, proprioceptive neuromuscular facilitation (PNF) stretching has been used to aid the rehabilitation of, for example, stroke patients by either facilitating muscle elongation and/or improving muscle strength. Positive effects were found (e.g., increased dorsiflexion, improved gait function, altered tendon properties), which are also clinically relevant for individuals with SCP. However, there is no information about the impact of PNF in this population. Aims: The primary aim of this study is to gain knowledge about both the effects of a single bout of static and PNF stretching and the effects of 8-week static and PNF stretching training on the calf muscle-tendon properties in children with SCP. Furthermore, the effects on joint and muscle function, stretch reflexes, gait, and self-reported gait function and functional performance are examined to receive a comprehensive picture of potential changes. Further aims of this study are to identify which stretching technique might be more efficient by comparing the effects of both stretching interventions, and to gain information about the influence of foot flexibility on the stretch achieved by the spastic gastrocnemius muscle-tendon unit. Methods: A randomized controlled trial with a cross-over design will be performed. Prior to the measurements, a familiarization session takes place and both groups will further be examined in three separate measurement sessions. Based on a power calculation and in order to account for possible dropouts, 30 individuals with SCP (age range: 6 to 15 years) will be recruited. The participants will be randomly allocated to either the static stretching or PNF stretching intervention after the familiarization session. Passive muscle-tendon morphological properties will be examined. A manually controlled instrumented spasticity assessment will be performed to test for differences in the reflex responses. Information about the lengthening behavior of the tissues throughout the dorsiflexion rotations will also be collected by use of ultrasound. Isometric muscle strength and the active torque-angle relationship will be investigated using an isokinetic dynamometer. To assess the gait pattern of the children, a gait analysis will be performed by use of an 8-camera motion capture system. In addition, we will examine the participants' gait function and functional performance by use of the Gait Outcomes Assessment List questionnaire.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Spastic
Keywords
Cerebral palsy, Stretching, Muscle-tendon unit, Spasticity, Gait

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Static stretching
Arm Type
Experimental
Arm Description
An 8-week home-based static stretching training for the calf muscles will be performed by group A. Altogether, 10 stretches are performed per leg 4 times a week.
Arm Title
Control
Arm Type
No Intervention
Arm Description
While group A performs the 8-week static stretching training, group B acts as control group performing its daily life activities as usual.
Arm Title
Proprioceptive neuromuscular facilitation stretching
Arm Type
Experimental
Arm Description
After group A has finished the 8-week static stretching training, group B starts with the 8-week home-based proprioceptive neuromuscular facilitation stretching training. Altogether, 10 stretches are performed per leg 4 times a week.
Arm Title
Follow-up
Arm Type
No Intervention
Arm Description
While group B performs the 8-week proprioceptive neuromuscular facilitation stretching, group A is in its follow-up period performing its daily life activities as usual.
Intervention Type
Other
Intervention Name(s)
Static stretching
Intervention Description
During the static stretching training for the calf muscles, the ankle joint is moved into maximal dorsiflexion until the point of discomfort is reached. The ankle joint is then held in this maximal position for 30 s followed by a rest period of 30 s. Afterwards, the procedure is repeated with the knee in flexed position to stretch the soleus muscle.
Intervention Type
Other
Intervention Name(s)
Proprioceptive neuromuscular facilitation stretching
Other Intervention Name(s)
PNF
Intervention Description
During the proprioceptive neuromuscular facilitation stretching, the ankle joint is moved into maximal dorsiflexion. While the foot is kept in this position, the child will perform a (sub-) maximal isometric contraction of the plantar flexors against the resistance of their parents. Afterwards, the ankle joint will be moved further into greater dorsiflexion and is held there for the remaining seconds followed by 30 s of rest. Subsequently, the stretch will be applied with the knee flexed.
Primary Outcome Measure Information:
Title
Change in mechano-morphological muscle-tendon properties
Description
Gastrocnemius medialis muscle morphology, muscle stiffness, tendon-aponeurosis length and stiffness, muscle-tendon unit length and stiffness, elongations of the tissues
Time Frame
baseline (T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks)
Title
Change in spasticity/stretch hyperreflexia
Description
Stretch reflex responses assessed by a manually controlled instrumented spasticity assessment
Time Frame
baseline (T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks)
Title
Change in joint range of motion
Description
Ankle joint range of motion (maximal plantarflexion - maximal dorsiflexion)
Time Frame
baseline (T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks)
Title
Change in active moment-angle relationship
Description
Maximum isometric voluntary contractions at specific ankle joint angles (isokinetic dynamometry)
Time Frame
baseline (T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks)
Secondary Outcome Measure Information:
Title
Change in gait characteristics
Description
Gait kinematics of the hip, knee, and ankle joints, gait kinetics (3D motion capture)
Time Frame
familiarisation session (T0, 1-week before T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks)
Title
Change in self-reported gait, mobility, and functional performance
Description
Gait Outcomes Assessment List (GOAL) questionnaire
Time Frame
familiarisation session (T0, 1-week before T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks)
Title
Change in maximal isometric muscle strength
Description
Maximal isometric torque production (isokinetic dynamometry)
Time Frame
baseline (T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks)
Other Pre-specified Outcome Measures:
Title
Foot flexibility
Description
Foot flexibility assessment by use of a gonio-dynamometer
Time Frame
familiarisation session (T0, 1 week before baseline assessment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: spastic cerebral palsy ambulatory children and adolescents ability to accept and follow verbal instructions no severe contracture of the calf muscles (max. ankle dorsiflexion >= 0°, with knees extended) classified as GMFCS level I, II, or III aged between 6 and 5 years willingness to participate Exclusion Criteria: others than spastic forms of cerebral palsy severe mental retardation fixed muscle contractures (ankle equinus deformity = max. ankle dorsiflexion <= 0°, with knees extended) oral anti-spastic and/or muscle relaxation medication in the last 6 months orthopaedic surgery and/or Botulinum toxin type A application in the last 12 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annika Kruse, Dr.rer.nat.
Organizational Affiliation
University of Graz, Institute of Human Movement Science, Sport and Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Human Movement Science, Sport and Health; University of Graz
City
Graz
ZIP/Postal Code
8010
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
It is yet not decided if individual data will be shared with other researchers.
Citations:
PubMed Identifier
24855614
Citation
Lee WY, Park GY, Kwon DR. Comparison of treatment effects between children with spastic cerebral palsy under and over five years after botulinum toxin type a injection. Ann Rehabil Med. 2014 Apr;38(2):200-8. doi: 10.5535/arm.2014.38.2.200. Epub 2014 Apr 29.
Results Reference
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PubMed Identifier
29573407
Citation
Willerslev-Olsen M, Choe Lund M, Lorentzen J, Barber L, Kofoed-Hansen M, Nielsen JB. Impaired muscle growth precedes development of increased stiffness of the triceps surae musculotendinous unit in children with cerebral palsy. Dev Med Child Neurol. 2018 Jul;60(7):672-679. doi: 10.1111/dmcn.13729. Epub 2018 Mar 24.
Results Reference
background
PubMed Identifier
22867763
Citation
Barber L, Barrett R, Lichtwark G. Medial gastrocnemius muscle fascicle active torque-length and Achilles tendon properties in young adults with spastic cerebral palsy. J Biomech. 2012 Oct 11;45(15):2526-30. doi: 10.1016/j.jbiomech.2012.07.018. Epub 2012 Aug 3.
Results Reference
background
PubMed Identifier
18480717
Citation
Wiart L, Darrah J, Kembhavi G. Stretching with children with cerebral palsy: what do we know and where are we going? Pediatr Phys Ther. 2008 Summer;20(2):173-8. doi: 10.1097/PEP.0b013e3181728a8c.
Results Reference
background
PubMed Identifier
17052131
Citation
Sharman MJ, Cresswell AG, Riek S. Proprioceptive neuromuscular facilitation stretching : mechanisms and clinical implications. Sports Med. 2006;36(11):929-39. doi: 10.2165/00007256-200636110-00002.
Results Reference
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PubMed Identifier
27895574
Citation
Zhou Z, Sun Y, Wang N, Gao F, Wei K, Wang Q. Robot-Assisted Rehabilitation of Ankle Plantar Flexors Spasticity: A 3-Month Study with Proprioceptive Neuromuscular Facilitation. Front Neurorobot. 2016 Nov 14;10:16. doi: 10.3389/fnbot.2016.00016. eCollection 2016.
Results Reference
background
PubMed Identifier
25570183
Citation
Zhou Z, Zhou Y, Wang N, Gao F, Wang L, Wei K, Wang Q. Changes of Achilles tendon properties via 12-week PNF based robotic rehabilitation of ankle joints with spasticity and/or contracture. Annu Int Conf IEEE Eng Med Biol Soc. 2014;2014:1214-7. doi: 10.1109/EMBC.2014.6943815.
Results Reference
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Stretching in Children and Adolescents With Spastic Cerebral Palsy

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