Cerebral Palsy, SpasticNCT06676540
Effect of Eccentric Exercise on Spasticity, Walking and Balance in Spastic Cerebral Palsy
A study testing Neurodevelopmental Therapy (NDT) and Eccentric Exercise Training Group (NDT+EE) and Neurodevelopmental Therapy (NDT) in people with Cerebral Palsy, Spastic, run by Lokman Hekim University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cerebral Palsy, Spastic
- What is being tested?
- Neurodevelopmental Therapy (NDT) and Eccentric Exercise Training Group (NDT+EE) and Neurodevelopmental Therapy (NDT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2024to 15 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Eccentric Exercise Training on Spasticity, Walking and Balance in Individuals With Spastic Cerebral Palsy
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.
Read the 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
- Being tested
- Neurodevelopmental Therapy (NDT) and Eccentric Exercise Training Group (NDT+EE), Neurodevelopmental Therapy (NDT)
- Keywords
- Gait Analysis, Postural Balance, Cerebral Palsy, eccentric exercise
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurodevelopmental Therapy (NDT) and Eccentric Exercise Training Group (NDT+EE)Other
Including Functional Eccentric Exercises Applied to Individuals with Cerebral Palsy
Neurodevelopmental Therapy (NDT)Other
This application includes rehabilitation methods frequently used in pediatric rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Neurodevelopmental Therapy (NDT) | Active comparator | 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. Receives: Other: Neurodevelopmental Therapy (NDT) |
| Neurodevelopmental Therapy (NDT) and Eccentric Exercise Training Group (NDT+EE) | Experimental | 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. Receives: Other: Neurodevelopmental Therapy (NDT) and Eccentric Exercise Training Group (NDT+EE); Other: Neurodevelopmental Therapy (NDT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Balance
Functional Balance will be evaluated with the 'Pediatric Balance Scale (PBS)'. PBS has been reported to be valid and reliable in the assessment of functional balance in patients with CP. This scale evaluates many different situations that will challenge balance during position transitions and upright positions during daily living activities. It consists of 14 questions that include activities such as sitting to standing, standing, transfers, taking steps, standing on one leg, turning, bending, and reaching. Each question is scored between 0-4. The total score of the test is 56. High scores indicate good balance performance.
Measured: 2 month
Stabilometric Balance Assessment (eyes open and eyes closed balance)
In this assessment, which is performed while standing still on a pedobarographic analysis device, objective data on postural sway and balance can be obtained together with static plantar pressure data. The data obtained with eyes open and closed are recorded. The decrease in postural sway between the two measurements with the numerical data obtained indicates that balance is better.
Measured: 2 month
Visual Gait Analysis
Will be evaluated with Edinburgh Visual Gait Analysis (EVGA). EVGA was developed to create an easy-to-use gait score that is compatible with 3-D gait analyses in children with CP. EGGA is a valid and reliable method for use in children with CP. EVGA consists of 17 items scored separately for the right and left lower extremities. The assessments include 6 anatomical levels: trunk, pelvis, hip, knee, ankle, and foot. These anatomical levels are assessed in the sagittal, coronal, and transverse planes. A 3-point ordinal scale is used for scoring. A score of 0 indicates normal, a score of 1 indicates moderate deviation from normal, and a score of 2 indicates significant deviation from normal. The scores obtained by watching camera recordings for each lower extremity are added up and a single score is obtained. A low score indicates normal; a high score indicates abnormal gait.
Measured: 2 month
Muscle Tone
Will be evaluated with 'Modified Ashworth Scale (MAS)'. It is a measurement method based on determining the resistance shown by the spastic muscle during passive movement of the relevant extremity. The 5-degree MAS was obtained by adding the value 1+ to the Asworth scale, which evaluates muscle tone between 0 and 4. The value 0 indicates a normal situation where there is no increase in muscle tone; while the value 4 indicates the maximum increase in muscle tone.
Measured: 2 month
Spasticity
Will be evaluated with 'Modified Tardieu Scale (MTS)'. Tardieu Scale was developed in 1954 and is a scale that evaluates spasticity with passive movement. The evaluation is made at the rate of the extremity segments falling with gravity, slower than this rate (R2) and faster than this rate (R1). This scale has been modified to evaluate at two different speeds, R1 and R2. For R1 and R2 values, the points where the muscle first resists during joint movement are measured with a goniometer. In the R1 evaluation, the sense of catching caused by the increased stretch reflex in fast joint movement (spasticity) is evaluated, while in the R2 evaluation, information is obtained about the range of motion and muscle length in slow joint movement. According to the MTS, it is accepted that the severity of spasticity increases as the difference between the R1 and R2 values increases.
Measured: 2 month
Secondary outcomes (2)
Lower extremity Range of Motion
Lower extremity active and passive normal joint range of motion values will be measured in degrees with a standard universal goniometer.
Measured: 2 month
Boyd and Graham's Selective Motor Control (SMC) Test
The "Selective Motor Control of Dorsiflexion Test" or "Boyd and Graham's Selective Motor Control (SMC) Test", defined by Boyd and Graham, was developed to evaluate ankle dorsiflexion (DF) SMC. It is associated with foot functions observed during walking. It is scored between 0 and 4. The person sits tall with hip flexion and knee extension so that they can see their feet and is asked to dorsiflex. A value of 0 indicates that there is no active ankle DF. A value of 4 indicates that isolated DF is performed without hip and knee flexion. A high score indicates that selectivity is good.
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start15 Aug 2024
- Primary completion30 Apr 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy, SpasticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lokman Hekim University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, HAKAN AYDIN, Lokman Hekim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06676540
- Sponsor's protocol ID
- Lokman Hekim Üniversitesi
- Status last verified
- Jan 2026
- First submitted
- 13 Oct 2024
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Eccentric Exercise Training on Spasticity, Walking and Balance in Individuals With Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06676540
- Acronym / sponsor ID
- Lokman Hekim Üniversitesi
- Conditions
- Cerebral Palsy, Spastic
- Keywords
- Gait Analysis, Postural Balance, Cerebral Palsy, eccentric exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Lokman Hekim UniversityOther government
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 6 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurodevelopmental Therapy (NDT) | Active comparator | Other: 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. |
| Neurodevelopmental Therapy (NDT) and Eccentric Exercise Training Group (NDT+EE) | Experimental | Other: Neurodevelopmental Therapy (NDT) and Eccentric Exercise Training Group (NDT+EE), Other: Neurodevelopmental Therapy (NDT)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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurodevelopmental Therapy (NDT) and Eccentric Exercise Training Group (NDT+EE)Including Functional Eccentric Exercises Applied to Individuals with Cerebral Palsy | Other | Neurodevelopmental Therapy (NDT) and Eccentric Exercise Training Group (NDT+EE) |
| Neurodevelopmental Therapy (NDT)This application includes rehabilitation methods frequently used in pediatric rehabilitation. | Other | Neurodevelopmental Therapy (NDT), Neurodevelopmental Therapy (NDT) and Eccentric Exercise Training Group (NDT+EE) |
Primary outcome
Functional Balance
Time frame: 2 month
Functional Balance will be evaluated with the 'Pediatric Balance Scale (PBS)'. PBS has been reported to be valid and reliable in the assessment of functional balance in patients with CP. This scale evaluates many different situations that will challenge balance during position transitions and upright positions during daily living activities. It consists of 14 questions that include activities such as sitting to standing, standing, transfers, taking steps, standing on one leg, turning, bending, and reaching. Each question is scored between 0-4. The total score of the test is 56. High scores indicate good balance performance.
Stabilometric Balance Assessment (eyes open and eyes closed balance)
Time frame: 2 month
In this assessment, which is performed while standing still on a pedobarographic analysis device, objective data on postural sway and balance can be obtained together with static plantar pressure data. The data obtained with eyes open and closed are recorded. The decrease in postural sway between the two measurements with the numerical data obtained indicates that balance is better.
Visual Gait Analysis
Time frame: 2 month
Will be evaluated with Edinburgh Visual Gait Analysis (EVGA). EVGA was developed to create an easy-to-use gait score that is compatible with 3-D gait analyses in children with CP. EGGA is a valid and reliable method for use in children with CP. EVGA consists of 17 items scored separately for the right and left lower extremities. The assessments include 6 anatomical levels: trunk, pelvis, hip, knee, ankle, and foot. These anatomical levels are assessed in the sagittal, coronal, and transverse planes. A 3-point ordinal scale is used for scoring. A score of 0 indicates normal, a score of 1 indicates moderate deviation from normal, and a score of 2 indicates significant deviation from normal. The scores obtained by watching camera recordings for each lower extremity are added up and a single score is obtained. A low score indicates normal; a high score indicates abnormal gait.
Muscle Tone
Time frame: 2 month
Will be evaluated with 'Modified Ashworth Scale (MAS)'. It is a measurement method based on determining the resistance shown by the spastic muscle during passive movement of the relevant extremity. The 5-degree MAS was obtained by adding the value 1+ to the Asworth scale, which evaluates muscle tone between 0 and 4. The value 0 indicates a normal situation where there is no increase in muscle tone; while the value 4 indicates the maximum increase in muscle tone.
Spasticity
Time frame: 2 month
Will be evaluated with 'Modified Tardieu Scale (MTS)'. Tardieu Scale was developed in 1954 and is a scale that evaluates spasticity with passive movement. The evaluation is made at the rate of the extremity segments falling with gravity, slower than this rate (R2) and faster than this rate (R1). This scale has been modified to evaluate at two different speeds, R1 and R2. For R1 and R2 values, the points where the muscle first resists during joint movement are measured with a goniometer. In the R1 evaluation, the sense of catching caused by the increased stretch reflex in fast joint movement (spasticity) is evaluated, while in the R2 evaluation, information is obtained about the range of motion and muscle length in slow joint movement. According to the MTS, it is accepted that the severity of spasticity increases as the difference between the R1 and R2 values increases.
2 secondary outcomes
Lower extremity Range of Motion
Time frame: 2 month
Boyd and Graham's Selective Motor Control (SMC) Test
Time frame: 2 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurodevelopmental Therapy (NDT) and Eccentric Exercise Training Group (NDT+EE) and Neurodevelopmental Therapy (NDT) in people with Cerebral Palsy, Spastic, run by Lokman Hekim University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Balance (time frame: 2 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.