Effect of Eccentric Exercise on Spasticity, Walking and Balance in Spastic Cerebral Palsy
- Conditions
- Cerebral Palsy, Spastic
- Registration Number
- NCT06676540
- Lead Sponsor
- Lokman Hekim Üniversitesi
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 42
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Functional Balance 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) 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 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.
Pedobaroghraphic Gait Analysis 2 month Will be evaluated with static and dynamic pedobaroghraphic gait analysis. With computer-aided static and dynamic pedobarographic analyses, plantar load distributions during foot contact with the ground, time-dependent variables, forefoot and hindfoot contact areas, maximum loading rates and spatio-temporal parameters of gait can be evaluated. These spatio-temporal parameters are; step length (cm), double step length (cm), step width (cm), cadence, walking speed, step duration and double step duration. Pedobagraphische Analyzes are used in individuals with CP for the evaluation of ambulation performance of the patient, suitability for planned treatment, treatment results, external support and surgical planning. In addition, it provides advanced, debatable and comparable objective data on spasticity and time-dependent variables of static and dynamic parameters related to gait in individuals with CP.
Muscle Tone 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 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.
- Secondary Outcome Measures
Name Time Method Lower extremity Range of Motion 2 month Lower extremity active and passive normal joint range of motion values will be measured in degrees with a standard universal goniometer.
Boyd and Graham's Selective Motor Control (SMC) Test 2 month 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.
Trial Locations
- Locations (1)
Lokman Hekim University
🇹🇷Ankara, Turkey