Effect of Botulinum Toxin on Selective Motor Control and Pain in Diplegic Cerebral Palsy
NCT Number: NCT06583343
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Cerebral Palsy Spastic Diplegia
Interventions: DRUG: OnabotulinumtoxinA|OTHER: Conventional Physical Therapy
Sponsor: Gaziosmanpasa Research and Education Hospital
Sex: ALL
Age: CHILD
Enrollment: 40
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-03
Completion Date: 2024-12-17
Locations: Gaziosmanpasa Research and Education Hospital, Istanbul, Gaziosmanpaşa, 34255, Turkey

Summary:
The aim of this study is to investigate the effects of Botulinum Neurotoxin-A (BoNT-A) injection applied to spastic muscles on pain sensation and Selective Motor Control (SMC) in cases diagnosed with diplegic spastic Cerebral Palsy.

Primary Outcome Measures: SCALE (Selective Control Assessment of the Lower Extremity), SCALE; it is a scale that can be easily applied in outpatient clinic conditions, does not require any equipment. A total of 5 regions are assessed: the hip, knee, ankle, subtalar joint, and toes.

Scoring is as follows: 0 (cannot be performed), 1 (impaired SMC), and 2 (normal). If the patient performs the movement correctly within 3 seconds, without moving any other joint besides the one being evaluated and without any mirror movement, it is considered normal SMC (2 points). If there is movement in another joint, mirror movement occurs, the range of motion is less than 50% of the passive ROM (Range Of Motion), or the movement takes longer than 3 seconds, it is considered impaired SMC (1 point). If the patient cannot initiate the movement or develops flexor/extensor synergy, it is scored as unachievable (0 points)., six weeks|Boyd and Graham SMC Test, This test, developed by Boyd and Graham, aims to evaluate the Selective Motor Control (SMC) of ankle dorsiflexion. The test assesses the patient's ability to activate the muscles responsible for ankle dorsiflexion (DF). It consists of 5 items and is scored on a scale from 0 to 4.

0: No movement at all when asked to dorsiflexion the foot.

1. Limited dorsiflexion achieved primarily through the use of extensor hallucis longus (EHL) and/or extensor digitorum brevis (EDB).
2. Limited dorsiflexion achieved using EHL, EDB, and some tibialis anterior (TA) muscle.
3. Dorsiflexion primarily using TA, but with accompanying hip and knee flexion.
4. Isolated selective ankle dorsiflexion (DF) achieved through isolated TA muscle activity without hip or knee flexion., six weeks|Visual Analog Scale (VAS), The Visual Analog Scale (VAS) is a very simple and easy-to-use pain scale where patients assess the intensity of their pain between "no pain" (0 points) and "unbearable pain" (10 points). The patient rates their pain on a scale from 0 to 10:

0: No pain 1-3: Mild pain 4-6: Moderate pain 7-10: Severe pain, six weeks
Secondary Outcome Measures: SCUES (Selective Control of the Upper Extremity Scale), SCUES; is a test that does not require special equipment and can be completed in less than 15 minutes. It evaluates a total of 5 joints in relation to their fundamental movement patterns: shoulder (abduction/adduction), elbow (flexion/extension), forearm (supination/pronation), wrist (flexion/extension), and fingers (grasp/release). Each joint is scored on a four-point scale:

0: No SMC (Selective Motor Control)

1. Moderately reduced SMC
2. Slightly reduced SMC
3. Normal SMC

The patient is seated, and the evaluator first demonstrates the appropriate movement on themselves. Then, the evaluator demonstrates the movement passively on the patient and asks the patient to replicate the movement. Four key indicators of impaired SMC are:

1. Presence of mirror movements
2. Movement of joints other than the target joint
3. Presence of trunk movements
4. Inability to achieve passive end-range of motion during dynamic movement, six weeks|Functional Independence Measure for Children (WeeFIM), It evaluates the effects of developmental problems on independence at home, school, and in the community. It guides clinicians in determining the level of daily living activities and motor skills in patients with CP, protecting them from potential secondary problems, predicting prognosis, and assessing the need for assistive devices., six weeks|Pediatric Quality of Life Inventory (PedsQL), It is designed to assess the quality of life in children and adolescents aged 2-18 years. There are a total of 4 subscales evaluating physical, emotional, social, and school-related functioning, with a total of 23 items. Each item is scored based on the response as 100, 75, 50, 25, or 0, then summed, and the total score is divided by the number of items to obtain the score for the corresponding subscale., six weeks|Child and Adolescent Participation Questionnaire (CASP), The CASP is a questionnaire that assesses the participation of patients with CP in various environments (such as home, school, and neighborhood). It consists of 4 subscales and 20 questions. Each item is scored on a scale from 0 to 4. As the total score increases, the individual's level of participation increases., six weeks