## Protocol Section
### Identification Module
**NCT ID:** NCT05682079

**Brief Title:** The Relationship Between Functional Exercise Capacity, Respiratory Muscle Strength, Trunk Control, Balance and Activities of Daily Living in Individuals With Cerebral Palsi

**Official Title:** Investigation of the Relationship Between Functional Exercise Capacity, Respiratory Muscle Strength, Trunk Control, Balance and Activities of Daily Living in Individuals With Spastic Cerebral Palsy.

#### Organization Study ID Info
**ID:** KirikkaleUni2
#### Organization
**Class:** OTHER
**Full Name:** Kırıkkale University
### Status Module
#### Completion Date
**Date:** 2022-11-15

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-09-01

**Type:** ACTUAL

**Last Update Submit Date:** 2023-08-31

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-10-15

**Type:** ACTUAL

#### Start Date
**Date:** 2022-08-15

**Type:** ACTUAL

**Status Verified Date:** 2023-08

#### Study First Post Date
**Date:** 2023-01-12
**Type:** ACTUAL
**Study First Submit Date:** 2022-12-23
**Study First Submit QC Date:** 2023-01-10
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** yeni kurtuluş özel eğitim ve rehabilitasyon merkezi

**Class:** UNKNOWN

**Name:** Özel Gelişim Akademi Özel Eğitim ve Rehabilitasyon Merkezi

#### Lead Sponsor

**Class:** OTHER

**Name:** Nursena Güçlü

#### Responsible Party

**Investigator Affiliation:** Kırıkkale University

**Investigator Full Name:** Nursena Güçlü

**Investigator Title:** fizyoterapist

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Cerebral palsy (CP) causes problems in posture, movement, breathing, postural control and balance in individuals. This work; This study was conducted to examine the relationship between functional exercise capacity, respiratory muscle strength, trunk control, balance and activities of daily living in individuals with spastic cerebral palsy.

**Detailed Description:** Cerebral palsy (CP) causes problems in posture, movement, breathing, postural control and balance in individuals. This work; This study was conducted to examine the relationship between functional exercise capacity, respiratory muscle strength, trunk control, balance and activities of daily living in individuals with spastic cerebral palsy.

23 children with spastic type CP and 22 typically developing children aged 6-18 years were included in the study. After recording the demographic data, the trunk control "Trunk control measurement scale" (TCMS), the activities of daily living "Pediatric Disability Assessment Inventory" (PDI), the balance "Pediatric Berg Balance Scale" (PBDI), functional exercise capacity "2 Minute Walking Test" and respiratory muscle strength was evaluated with maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) measurements. Compared to individuals with typical development, individuals with CP had lower TCMS, PPI, PBRS, 2-minute walking test and respiratory muscle strength values (p\<0.01). At the same time, it was observed that individuals with hemiparetic CP had better TCMS, PPI, PBRS scores, functional exercise capacities and respiratory muscle strength compared to individuals with diparetic disease and individuals with CP at GMFCS I level compared to individuals with other levels. It was found that there was a high correlation between trunk control, balance and functional capacity of individuals with CP. It was concluded that the influence on trunk control affects balance and functional capacity. There was also a correlation between the scales.

### Conditions Module

**Conditions:**

- Cerebral Palsy, Spastic

**Keywords:**

- Trunk Control

- Respiratory Muscle Strength

- Balance

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 45

**Type:** ACTUAL

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 14 Days

### Arms Interventions Module

#### Arm Group 1

**Description:** After recording demographic data, "Trunk control measurement scale" (TCMS) to evaluate trunk control, "Gorge motor function classification system" (GMFCS) to measure gross motor functions, "Pediatric Disability Assessment Inventory" (PDI) to evaluate activities of daily living, balance 'Pediatric Berg Balance Scale' was used to evaluate functional capacities and '2-minute walking test' was used to evaluate functional capacities. In addition, respiratory muscle strength was evaluated with maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) measurements.

**Intervention Names:**

- Other: TCMS, PEDİ, respiration, GMFCS,PBS,functional capacity

**Label:** children with cerebral palsy

#### Arm Group 2

**Description:** After recording demographic data, "Trunk control measurement scale" (TCMS) to evaluate trunk control, "Gorge motor function classification system" (GMFCS) to measure gross motor functions, "Pediatric Disability Assessment Inventory" (PDI) to evaluate activities of daily living, balance 'Pediatric Berg Balance Scale' was used to evaluate functional capacities and '2-minute walking test' was used to evaluate functional capacities. In addition, respiratory muscle strength was evaluated with maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) measurements.

**Intervention Names:**

- Other: TCMS, PEDİ, respiration, GMFCS,PBS,functional capacity

**Label:** typical kids

### Interventions

#### Intervention 1

**Arm Group Labels:**

- children with cerebral palsy

- typical kids

**Description:** The Trunk Control Measurement Scale evaluates the two main components of trunk control, static sitting balance and dynamic sitting balance. The scale includes a total of 15 items. The Pediatric Disability Assessment Inventory evaluates ADLs in individuals between the ages of 6 months and 7.5 years. It is a detailed clinical assessment scale that evaluates the functional skills and performance of individuals. Items in this section are scored as "0=cannot" and "1=can". The Pediatric Berg Balance Scale is an adapted version of the Berg Balance test for adults, which consists of 14 questions. It is a scale that consists of 14 questions and evaluates balance functionally. For the 2-minute walking test; They were asked to walk at their own pace without running for 2 minutes on a quiet, concrete walkway 15 m long. It was repeated 2 times with a 10-minute rest between each trial. Respiratory muscle strength was measured using a portable, electronic mouth pressure measuring device.

**Name:** TCMS, PEDİ, respiration, GMFCS,PBS,functional capacity

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Level I: Walks without restraint. Level II: Walks with restrictions. Level III: Walks using hand-held mobility devices. Level IV: Self-movement is restricted. Can use a motorized mobility vehicle. Level V: Transported in a manual wheelchair.

**Measure:** Gross Motor Function Classification System (GMFCS)

**Time Frame:** 2 week

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Being between 6-18 years old,
* Having been diagnosed with spastic hemiplegic or spastic diplegic cerebral palsy,
* No communication problem,
* GMFCS level was determined to be between I-III.

Exclusion Criteria:

* The parent who will answer the form does not know Turkish,
* Orthopedic surgical treatment and botulinum toxin injection in the 6 months before the study,
* It was determined as having other orthopedic, neurological and cardiopulmonary diseases that may affect balance and gait.

**Healthy Volunteers:** True

**Maximum Age:** 18 Years

**Minimum Age:** 6 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

**Study Population:** Individuals aged 6-18 years

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Ankara

**Country:** Turkey

**Facility:** Fzt. Nur Sena Güçlü

**State:** Çankaya

**Zip:** 06510

#### Overall Officials

**Official 1:**

**Affiliation:** kırıkkale üniversitesi

**Name:** saniye aydoğan arslan

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001925

- Term: Brain Damage, Chronic

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000009135

- Term: Muscular Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000009122

- Term: Muscle Hypertonia

- ID: D000020879

- Term: Neuromuscular Manifestations

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5796

- Name: Cerebral Palsy

- Relevance: HIGH

- As Found: Cerebral Palsy

- ID: M12085

- Name: Muscle Spasticity

- Relevance: HIGH

- As Found: Spastic

- ID: M13157

- Name: Paralysis

- Relevance: LOW

- As Found: Unknown

- ID: M5207

- Name: Brain Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M5202

- Name: Brain Damage, Chronic

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12092

- Name: Muscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12079

- Name: Muscle Hypertonia

- Relevance: LOW

- As Found: Unknown

- ID: M22619

- Name: Neuromuscular Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009128

- Term: Muscle Spasticity

- ID: D000002547

- Term: Cerebral Palsy

### Misc Info Module

- Version Holder: 2024-05-24
