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Clinical Trials/NCT04570358
NCT04570358
Completed
Not Applicable

Stretching in Children With Spastic Cerebral Palsy

University of Graz1 site in 1 country24 target enrollmentSeptember 11, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy, Spastic
Sponsor
University of Graz
Enrollment
24
Locations
1
Primary Endpoint
Change in spasticity/stretch hyperreflexia
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 11, 2020
End Date
September 23, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
University of Graz
Responsible Party
Principal Investigator
Principal Investigator

Dr. Annika Kruse

Principal investigator

University of Graz

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

Outcomes

Primary Outcomes

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

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)

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)

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

Secondary Outcomes

  • Change in gait characteristics(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))
  • 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))

Study Sites (1)

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