NCT04570358

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 11, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 30, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2021

Completed
Last Updated

October 12, 2021

Status Verified

October 1, 2021

Enrollment Period

1 year

First QC Date

September 14, 2020

Last Update Submit

October 11, 2021

Conditions

Keywords

Cerebral palsyStretchingMuscle-tendon unitSpasticityGait

Outcome Measures

Primary Outcomes (4)

  • 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

    baseline (T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks)

  • Change in spasticity/stretch hyperreflexia

    Stretch reflex responses assessed by a manually controlled instrumented spasticity assessment

    baseline (T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks)

  • Change in joint range of motion

    Ankle joint range of motion (maximal plantarflexion - maximal dorsiflexion)

    baseline (T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks)

  • Change in active moment-angle relationship

    Maximum isometric voluntary contractions at specific ankle joint angles (isokinetic dynamometry)

    baseline (T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks)

Secondary Outcomes (3)

  • Change in gait characteristics

    familiarisation session (T0, 1-week before T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks)

  • Change in self-reported gait, mobility, and functional performance

    familiarisation session (T0, 1-week before T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks)

  • Change in maximal isometric muscle strength

    baseline (T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks)

Other Outcomes (1)

  • Foot flexibility

    familiarisation session (T0, 1 week before baseline assessment)

Study Arms (4)

Static stretching

EXPERIMENTAL

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.

Other: Static stretching

Control

NO INTERVENTION

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

Proprioceptive neuromuscular facilitation stretching

EXPERIMENTAL

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.

Other: Proprioceptive neuromuscular facilitation stretching

Follow-up

NO INTERVENTION

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.

Interventions

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.

Static stretching

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.

Also known as: PNF
Proprioceptive neuromuscular facilitation stretching

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Graz, 8010, Austria

Location

Related Publications (8)

  • 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.

    PMID: 24855614BACKGROUND
  • 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.

    PMID: 29573407BACKGROUND
  • 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.

    PMID: 22867763BACKGROUND
  • 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.

    PMID: 18480717BACKGROUND
  • 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.

    PMID: 17052131BACKGROUND
  • 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.

    PMID: 27895574BACKGROUND
  • 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.

    PMID: 25570183BACKGROUND
  • Kruse A, Habersack A, Weide G, Jaspers RT, Svehlik M, Tilp M. Eight weeks of proprioceptive neuromuscular facilitation stretching and static stretching do not affect muscle-tendon properties, muscle strength, and joint function in children with spastic cerebral palsy. Clin Biomech (Bristol). 2023 Jul;107:106011. doi: 10.1016/j.clinbiomech.2023.106011. Epub 2023 Jun 7.

MeSH Terms

Conditions

Cerebral PalsyMuscle Spasticity

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Annika Kruse, Dr.rer.nat.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 14, 2020

First Posted

September 30, 2020

Study Start

September 11, 2020

Primary Completion

September 23, 2021

Study Completion

September 23, 2021

Last Updated

October 12, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

It is yet not decided if individual data will be shared with other researchers.

Locations