Stretching in Children and Adolescents With Spastic Cerebral Palsy

Cerebral Palsy, Spastic Clinical Trial

Official title:

Stretching in Children With Spastic Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04570358
• Other study ID #: T1017
• Secondary ID: T1017-B27
• Status: Completed
• Phase: N/A
• Start date: September 11, 2020
• Est. completion date: September 23, 2021

Study information

• Verified date: October 2021
• Source: University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 23, 2021
• Est. primary completion date: September 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy, Spastic
• Muscle Spasticity
• Paralysis

Intervention

Other:
• Static stretching
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.
• Proprioceptive neuromuscular facilitation 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.

Locations

Country	Name	City	State
Austria	Institute of Human Movement Science, Sport and Health; University of Graz	Graz

Sponsors (2)

Lead Sponsor	Collaborator
University of Graz	VU University of Amsterdam

Country where clinical trial is conducted

Austria, 

References & Publications (7)

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. — View 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. — View Citation

Sharman MJ, Cresswell AG, Riek S. Proprioceptive neuromuscular facilitation stretching : mechanisms and clinical implications. Sports Med. 2006;36(11):929-39. Review. — View 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. Review. — View 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. — View 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. eCollection 2016. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Foot flexibility	Foot flexibility assessment by use of a gonio-dynamometer	familiarisation session (T0, 1 week before baseline assessment)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Change in gait characteristics	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)
Secondary	Change in self-reported gait, mobility, and functional performance	Gait Outcomes Assessment List (GOAL) questionnaire	familiarisation session (T0, 1-week before T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks)
Secondary	Change in maximal isometric muscle strength	Maximal isometric torque production (isokinetic dynamometry)	baseline (T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks)