Clinical trial NCT06676540: Effect of Eccentric Exercise on Spasticity, Walking and Balance in Spastic Cerebral Palsy
Official title: Effect of Eccentric Exercise Training on Spasticity, Walking and Balance in Individuals With Spastic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy, Spastic
Keywords: Gait Analysis
Postural Balance
Cerebral Palsy
eccentric exercise
Lead sponsor: Lokman Hekim Üniversitesi
Sponsor class: OTHER_GOV
First posted: 2024-11-06
Enrollment: 42
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Functional Balance
timeFrame: 2 month
measure: Stabilometric Balance Assessment (eyes open and eyes closed balance)
timeFrame: 2 month
measure: Visual Gait Analysis
timeFrame: 2 month
measure: Pedobaroghraphic Gait Analysis
timeFrame: 2 month
measure: Muscle Tone
timeFrame: 2 month
measure: Spasticity
timeFrame: 2 month
Secondary outcomes:
measure: Lower extremity Range of Motion
timeFrame: 2 month
measure: Boyd and Graham's Selective Motor Control (SMC) Test
timeFrame: 2 month
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Lokman Hekim University
Study officials:
References: