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

NCT07007858 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-06-01
Last updated
2025-06-06

Condition(s) studied

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

Investigational drug(s) / intervention(s)

ExerciseExercise

Exercise: 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.

Exercise: In addition to standard physical therapy (including strengthening exercises, weight-bearing, balance, proprioception, and gait training), standard stretching will be applied to the ankle joint three sessions per week. Stretching will be performed for a total of 15 minutes per leg in each session, consisting of 10 repetitions of 60 seconds with 30-second rest intervals. During the 4-week intervention period, the exercises will be taught to the families and continued at home as a home exercise program for up to six months

Study 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.

Eligibility

Sex
ALL
Min age
2 Years
Max age
8 Years
Healthy volunteers
Accepted
Inclusion Criteria: * 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) Exclusion Criteria: * 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

Primary outcome measure(s)

  • Fascicle length measured via ultrasound in maximum dorsiflexion and resting positions. — Patients will be assessed at the hospital before the BoNT-A injection and at the 1st, 3rd, and 6th months following the injection
    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.

Trial sites (1)

FacilityCityRegionStatus
Erciyes University Faculty of Medicine Hospital Kayseri Turkey
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07007858 on ClinicalTrials.gov ↗ ← All trials in Turkey