Effect of Eccentric Exercise on Spasticity, Walking and Balance in Spastic Cerebral Palsy

NCT ID: NCT06676540

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-15
• Study Completion Date: 2025-06-15

Brief Summary

Our clinical research study is planned as a randomized controlled study and will use a stratified randomization method. The aim of this study is to investigate the effects of eccentric exercise training on spasticity, walking and balance in individuals with spastic Cerebral Palsy (CP). Individuals with spastic unilateral SP (hemiparetic) and bilateral SP (diparetic) diagnosis, Gross Motor Function Classification System (GMFCS) Level I, II and III, aged between 6-18 years will be included in the study.

Detailed Description

As a result of the G-power analysis, it was revealed that a total of 42 individuals should be included in the control and study groups. In our study, a control group of 21 people (Neurodevelopmental Treatment Group-NGT/2 days per week, 40 minutes) and an experimental group (Neurodevelopmental Treatment + Eccentric Exercise Group-NGT+EE/2 sessions per week, 20 minutes NGT + 30 minutes eccentric exercise program) will be formed. After the initial evaluations, 2 physiotherapy sessions per week will be applied to both groups for 8 weeks and then the final evaluations will be made and the obtained data will be compared with the initial evaluation data to reveal the statistical effect of eccentric exercises on spasticity, walking and balance parameters.

The hypotheses of the study are as follows:

H1: Eccentric exercise training for spastic lower extremity muscles in individuals with spastic cerebral palsy has an effect on spasticity severity.

H2: Eccentric exercise training for spastic lower extremity muscles in individuals with spastic cerebral palsy has an effect on gait parameters.

H3: Eccentric exercise training for spastic lower extremity muscles in individuals with spastic cerebral palsy has an effect on balance parameters.

H4: Eccentric exercise training for spastic lower extremity muscles in individuals with spastic cerebral palsy has an effect on quality of life, activities of daily living (ADL), and participation.

Conditions

Cerebral Palsy, Spastic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Neurodevelopmental Therapy (NDT)

The Neurodevelopmental Therapy (NDT) treatment program, which was determined by the physiotherapist to be individual and suitable for the needs of the cases in both groups participating in the study, will continue throughout the study, with 2 sessions per week and 40 minutes each session. The orthoses and assistive devices used by the cases will continue to be used without any changes and no changes will be made to the treatment program.

Group Type: ACTIVE_COMPARATOR

Neurodevelopmental Therapy (NDT)

Intervention Type: OTHER

This application includes rehabilitation methods frequently used in pediatric rehabilitation.

Neurodevelopmental Therapy (NDT) and Eccentric Exercise Training Group (NDT+EE)

The subjects in the study group will be applied NDT 20 minutes twice a week, each session lasting 40 minutes, and in addition, an eccentric exercise program of 20 minutes will be applied in each session. For eccentric exercise training, a functional eccentric exercise program will be applied especially for the hip flexor (m. iliopsoas, m. rectus femoris) muscle group, which is the most common and intense spasticity seen in the lower extremities, hip adductors (m. adductor magnus and minimus, m. adductor longus and brevia, m. pectineus, m. gracillis), knee flexors (m. semitendinosus, m. semimembranouzsu, m. biceps femoris) and plantar flexors (m. gastrocnemius, m. soleus and m. tibialis posterior). If the orthosis used by the individual is applied during the eccentric exercise program, it will be removed.

Group Type: EXPERIMENTAL

Neurodevelopmental Therapy (NDT) and Eccentric Exercise Training Group (NDT+EE)

Intervention Type: OTHER

Including Functional Eccentric Exercises Applied to Individuals with Cerebral Palsy

Neurodevelopmental Therapy (NDT)

Intervention Type: OTHER

This application includes rehabilitation methods frequently used in pediatric rehabilitation.

Interventions

Neurodevelopmental Therapy (NDT) and Eccentric Exercise Training Group (NDT+EE)

Including Functional Eccentric Exercises Applied to Individuals with Cerebral Palsy

Intervention Type: OTHER

Neurodevelopmental Therapy (NDT)

This application includes rehabilitation methods frequently used in pediatric rehabilitation.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Being between the ages of 6-18 and diagnosed with spastic hemiparetic or spastic diparetic CP,
• Being at level I, II or III according to GMFCS,
• Having increased muscle tone in hip flexor, hip adductor, knee flexor, knee extensor or ankle plantar flexor muscles according to MTS,
• Giving informed consent including detailed information prepared for the study (by parent/guardian).

Exclusion Criteria

• Having received botox or surgery in the last 6 months.
• Not signing the consent form.
• Having limited cooperation regarding perception or performance of exercises required for the study.
• Having a systemic disease in addition to CP.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lokman Hekim University

OTHER_GOV

Sponsor Role: lead

Responsible Party

HAKAN AYDIN

M.Sc. Pt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lokman Hekim University

Ankara, Ankara, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Lokman Hekim Üniversitesi

Identifier Type: -

Identifier Source: org_study_id