Stretching in Children and Adolescents With Spastic Cerebral Palsy

October 11, 2021 updated by: Dr. Annika Kruse, University of Graz

Stretching in Children With Spastic Cerebral Palsy

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Graz, Austria, 8010
        • Institute of Human Movement Science, Sport and Health; University of Graz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Static stretching
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.
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.
No Intervention: Control
While group A performs the 8-week static stretching training, group B acts as control group performing its daily life activities as usual.
Experimental: Proprioceptive neuromuscular facilitation stretching
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.
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.
Other Names:
  • PNF
No Intervention: Follow-up
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in mechano-morphological muscle-tendon properties
Time Frame: baseline (T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks)
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
Time Frame: baseline (T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks)
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
Time Frame: baseline (T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks)
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
Time Frame: baseline (T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in gait characteristics
Time Frame: familiarisation session (T0, 1-week before T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks)
Gait kinematics of the hip, knee, and ankle joints, gait kinetics (3D motion capture)
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
Time Frame: familiarisation session (T0, 1-week before T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks)
Gait Outcomes Assessment List (GOAL) questionnaire
familiarisation session (T0, 1-week before T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks)
Change in maximal isometric muscle strength
Time Frame: baseline (T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks)
Maximal isometric torque production (isokinetic dynamometry)
baseline (T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Foot flexibility
Time Frame: familiarisation session (T0, 1 week before baseline assessment)
Foot flexibility assessment by use of a gonio-dynamometer
familiarisation session (T0, 1 week before baseline assessment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Annika Kruse, Dr.rer.nat., University of Graz, Institute of Human Movement Science, Sport and Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2020

Primary Completion (Actual)

September 23, 2021

Study Completion (Actual)

September 23, 2021

Study Registration Dates

First Submitted

September 14, 2020

First Submitted That Met QC Criteria

September 29, 2020

First Posted (Actual)

September 30, 2020

Study Record Updates

Last Update Posted (Actual)

October 12, 2021

Last Update Submitted That Met QC Criteria

October 11, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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