Effects of High-Velocity Passive Stretch on Spasticity, Function, and Muscle Structure in Spastic CP Children
Key facts
- Who runs it
- TC Erciyes University
- Where
- Türkiye1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Enrolling by invitation
- People taking part
- 34 people, planned
- Started
- 1 Jun 2026
- Planned end
- 1 Jul 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Exercise
- Record updated
- 6 June 2025
Who can take part
- Age
- 2 years to 8 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
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Who can take part
- 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)
Who cannot take part
- Receiving serial casting or spasticity treatments (e.g., baclofen or BoNT-A) within the past 6 months
- Having a neuromuscular disorder other than cerebral palsy
- 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
- Presence of a fixed foot deformity
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 2 and 8 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- Standard Stretching + Standard Physical Therapy following BoNT-A InjectionExisting treatment, for comparison
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.
Treatment: Exercise
- High-Velocity Stretching + Standard Physical Therapy following BoNT-A InjectionTreatment being tested
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
Treatment: Exercise
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effects of High-Velocity Passive Stretching Protocol on Spasticity, Functional Status, and Muscle Architecture in Children With Spastic Cerebral Palsy
- Fit questions
- Built from NCT07007858, who can take part
- Record updated
- 6 June 2025