Effects of High-Velocity Passive Stretch on Spasticity, Function, and Muscle Structure in Spastic CP Children

NCT07007858 | Enrolling By Invitation DMC

• 1 other identifier: 2025/197
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

One of the traditional exercises applied to cerebral palsy (CP) is passive stretching exercises. Passive stretching exercises can be applied to these patients at various speeds. A recent study has shown that high-speed passive stretching in children with CP can increase muscle bundle length in spastic muscles. Therefore, high-speed stretching exercises may potentiate the positive effects of BoNT-A treatment on spasticity and muscle fascicle in patients with CP. This study aims to investigate whether fast stretching exercises administered to children with CP following BoNT-A injection are more effective than standard stretching in improving spasticity, functional status, and muscle architecture.

Conditions

Cerebral Palsy (CP); Spastic Diplegia Cerebral Palsy; Spastic Hemiplegic Cerebral Palsy

Keywords

exercise; strecthing; muscle fascicle; ultrasound; cerebral palsy; botulinum toxin

Outcome Measures

Primary Outcomes (1)

• Fascicle length measured via ultrasound in maximum dorsiflexion and resting positions.

  The patient will be positioned prone with the ankle hanging freely off the edge of the examination table. Imaging will be performed over the medial gastrocnemius in full knee extension (0° flexion) during both maximum dorsiflexion (MDF) and resting positions. Using two-dimensional ultrasound, the length of the longest fascicle extending between the superficial and deep fascia will be measured at the thickest point of the medial gastrocnemius muscle.

  Patients will be assessed at the hospital before the BoNT-A injection and at the 1st, 3rd, and 6th months following the injection

Secondary Outcomes (7)

• Pennation angle

  Patients will be assessed at the hospital before the BoNT-A injection and at the 1st, 3rd, and 6th months following the injection

• Gastrocnemius muscle thickness

  Patients will be assessed at the hospital before the BoNT-A injection and at the 1st, 3rd, and 6th months following the injection

• Assessment of Spasticity (Modifiye ashworth classification)

  Patients will be assessed at the hospital before the BoNT-A injection and at the 1st, 3rd, and 6th months following the injection

• Assessment of Spasticity (Tardie Scale)

  Patients will be assessed at the hospital before the BoNT-A injection and at the 1st, 3rd, and 6th months following the injection

• Range of Motion

  Patients will be assessed at the hospital before the BoNT-A injection and at the 1st, 3rd, and 6th months following the injection

Study Arms (2)

Standard Stretching + Standard Physical Therapy following BoNT-A Injection

ACTIVE COMPARATOR

Participants received BoNT-A injections into the gastrocnemius muscle at clinically appropriate doses, based on individual clinical presentations and within established indications. In addition to standard physical therapy-including strengthening exercises, weight-bearing activities, balance training, proprioceptive exercises, and gait training-a standardized ankle joint stretching protocol was administered three sessions per week under the supervision of a physiotherapist. Stretching was performed for 15 minutes per leg per session, consisting of 10 repetitions of 60-second stretches with 30-second rest intervals between repetitions. The intervention period lasted four weeks. During this period, the exercises were administered by a physiotherapist. In parallel, the exercise program was taught to the families, and following the supervised phase, it was continued as a home-based exercise program for up to six months.

Other: Exercise

High-Velocity Stretching + Standard Physical Therapy following BoNT-A Injection

EXPERIMENTAL

Participants received BoNT-A injections into the gastrocnemius muscle at clinically appropriate doses, based on their individual clinical presentation and within established indications. In addition to standard physical therapy-including strengthening exercises, weight-bearing activities, balance training, proprioception, and gait training-a rapid stretching protocol was administered. Rapid stretching was performed starting from the initial position, first at the slowest possible velocity (V1) for 5 minutes, as described in the Tardieu method, followed by stretching at the fastest possible velocity (V3), sufficient to elicit a catch, for 10 minutes. A 1-minute rest period was provided during each stretching session. This protocol was conducted three times per week for four weeks under the supervision of a physiotherapist. After the supervised phase, the stretching exercises were taught to the families and continued at home for up to six months as a home-based program, without veloci

Other: Exercise

Interventions

Exercise OTHER

In addition to standard physical therapy (including strengthening exercises, weight-bearing, balance, proprioception, and gait training), stretching will be applied to the ankle joint as described by Tardieu: first at a velocity as slow as possible (V1) for 5 minutes, followed by stretching at the fastest possible velocity (V3), sufficient to elicit a catch, for 10 minutes. A 1-minute rest period will be provided between each stretch. This protocol will be conducted three times per week for four weeks under the supervision of a physiotherapist. Afterward, the exercise will be taught to the families and continued at home as a home-based program for up to six months, without velocity measurement.

Also known as: Standard physical therapy + High-velocity stretching

High-Velocity Stretching + Standard Physical Therapy following BoNT-A Injection

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 2 to 8 years diagnosed with cerebral palsy of the hemiplegic or diplegic type according to the Rosenbaum criteria
• Presence of spasticity in the ankle plantar flexors with a Modified Ashworth Scale (MAS) score of 1, 1+, 2, or 3, and a clinical indication for BoNT-A injection into the gastrocnemius or gastrocnemius/soleus muscles at this stage of treatment
• Gross Motor Function Classification System (GMFCS) levels of 1, 2, or 3 (ambulatory)

You may not qualify if:

• Having a neuromuscular disorder other than cerebral palsy
• Presence of a fixed foot deformity
• Receiving serial casting or spasticity treatments (e.g., baclofen or BoNT-A) within the past 6 months
• History of surgery
• Having intellectual or behavioral difficulties, or comorbid conditions (such as cardiac, respiratory disorders or uncontrolled seizures) that prevent safe participation in exercise

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University Faculty of Medicine Hospital

Kayseri, Turkey, 38100, Turkey (Türkiye)

Location

Related Publications (8)

• Lichtwark GA, Bougoulias K, Wilson AM. Muscle fascicle and series elastic element length changes along the length of the human gastrocnemius during walking and running. J Biomech. 2007;40(1):157-64. doi: 10.1016/j.jbiomech.2005.10.035. Epub 2005 Dec 20.

  PMID: 16364330 BACKGROUND

• Benard MR, Becher JG, Harlaar J, Huijing PA, Jaspers RT. Anatomical information is needed in ultrasound imaging of muscle to avoid potentially substantial errors in measurement of muscle geometry. Muscle Nerve. 2009 May;39(5):652-65. doi: 10.1002/mus.21287.

  PMID: 19291798 BACKGROUND

• Gracies JM, Burke K, Clegg NJ, Browne R, Rushing C, Fehlings D, Matthews D, Tilton A, Delgado MR. Reliability of the Tardieu Scale for assessing spasticity in children with cerebral palsy. Arch Phys Med Rehabil. 2010 Mar;91(3):421-8. doi: 10.1016/j.apmr.2009.11.017.

  PMID: 20298834 BACKGROUND

• Zurawski E, Behm K, Dunlap C, Koo J, Ismail F, Boulias C, Reid S, Phadke CP. Interrater Reliability of the Modified Ashworth Scale with Standardized Movement Speeds: A Pilot Study. Physiother Can. 2019 Fall;71(4):348-354. doi: 10.3138/ptc-2018-0086.

  PMID: 31762545 BACKGROUND

• Theis N, Korff T, Mohagheghi AA. Does long-term passive stretching alter muscle-tendon unit mechanics in children with spastic cerebral palsy? Clin Biomech (Bristol). 2015 Dec;30(10):1071-6. doi: 10.1016/j.clinbiomech.2015.09.004. Epub 2015 Sep 8.

  PMID: 26403361 BACKGROUND

• Banky M, Clark RA, Mentiplay BF, Olver JH, Kahn MB, Williams G. Toward Accurate Clinical Spasticity Assessment: Validation of Movement Speed and Joint Angle Assessments Using Smartphones and Camera Tracking. Arch Phys Med Rehabil. 2019 Aug;100(8):1482-1491. doi: 10.1016/j.apmr.2018.11.026. Epub 2019 Jan 24.

  PMID: 30684484 BACKGROUND

• Kawano A, Yanagizono T, Kadouchi I, Umezaki T, Chosa E. Ultrasonographic evaluation of changes in the muscle architecture of the gastrocnemius with botulinum toxin treatment for lower extremity spasticity in children with cerebral palsy. J Orthop Sci. 2018 Mar;23(2):389-393. doi: 10.1016/j.jos.2017.10.012. Epub 2017 Nov 14.

  PMID: 29146092 BACKGROUND

• Davis JF, Khan T, Thornton M, Reeves ND, DeLuca M, Mohagheghi AA. High Velocity Passive Stretching Mimics Eccentric Exercise in Cerebral Palsy and May Be Used to Increase Spastic Muscle Fascicle Length. Bioengineering (Basel). 2024 Jun 13;11(6):608. doi: 10.3390/bioengineering11060608.

  PMID: 38927844 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Cerebral palsy, spastic, diplegic; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• İsa C Associate Professor

  Erciyes University Faculty of Medicine Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: June 6, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)