Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06209840
Other study ID # AYBU-NOUNLER-001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2023
Est. completion date June 20, 2024

Study information

Verified date January 2024
Source Ankara Yildirim Beyazit University
Contact Sena ÇARIKCI, MSc
Phone 05054284172
Email senacrkc@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main purpose of this study is to investigate the effect of music therapy on the upper extremity functions and quality of life of individuals with Cerebral Palsy (CP). The secondary aim is to investigate the effect of music therapy on the sensory functions of the upper extremity in individuals with CP. Adolescent individuals with hemiparetic CP will participate in this study, and the participants will experience music therapy, which is a scientific intervention approach. If music therapy has a positive effect on upper extremity functions, they will be more active in daily life and their quality of life will increase. In the light of these data to be presented, a contribution will be made to the evidence level of music therapy in the literature and to the content of SP upper extremity rehabilitation.


Recruitment information / eligibility

Status Recruiting
Enrollment 24
Est. completion date June 20, 2024
Est. primary completion date March 17, 2024
Accepts healthy volunteers No
Gender All
Age group 6 Years to 21 Years
Eligibility Inclusion Criteria: - Between the ages of 6-21 - With upper extremity dysfunction - MACS score between 2-4, - According to MAS, spasticity severity ranges from (1+) to (3), - Individuals diagnosed with hemiparetic Cerebral Palsy who are at a cognitive level that can follow simple instructions during applications and evaluations will be included. Exclusion Criteria: - Having another neurological disorder - Having undergone upper extremity orthopedic surgery or Botulinum Toxin A (BTX-A) application in the last 6 months, - Individuals currently receiving another rehabilitation program in addition to classical physiotherapy for upper extremity rehabilitation will be excluded from the study.

Study Design


Intervention

Other:
Control Group
The session is 50 minutes long and consists of 20 minutes of classical physiotherapy for gross motor functions and 30 minutes of classical physiotherapy for the upper extremity. A total of 16 sessions will be applied 2 days a week for 8 weeks.
Study (Music) Group
The session is 50 minutes long and consists of 20 minutes of classical physiotherapy for gross motor functions and 30 minutes of music therapy for the upper extremity. A total of 16 sessions will be applied 2 days a week for 8 weeks.

Locations

Country Name City State
Turkey Sena ÇARIKCI Ankara

Sponsors (1)

Lead Sponsor Collaborator
Ankara Yildirim Beyazit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other The Gross Motor Function Classification System (GMFCS) The Gross Motor Function Classification System (GMFCS) determines the level most appropriate to an individual's limitations and skills in gross motor functions. This classification measures the individual's self-initiated movements based on displacement, sitting and mobility, regardless of the individual's motor disorder type. As a result of the findings, individuals are divided into 5 levels according to their motor function levels. Individuals at Level 1 have minimal motor limitations. Before the start of treatment
Other The Manual Ability Classification System (MACS) The Manual Ability Classification System (MACS) classifies how individuals with CP use their hands when holding objects in their daily activities in five levels. The individual at level 1 can hold and use objects easily and successfully, while the individual at level 5 cannot hold and use objects and has extremely limited skills to perform even simple activities. When determining levels, the ability of individuals to hold objects by themselves and the need for assistance in performing manual activities in daily life are taken into account. Before the start of treatment
Primary Children's Hand-Use Experience Questionnaire (CHEQ) Children's Hand-Use Experience Questionnaire (CHEQ) is a scale that evaluates unilateral hand disorders in children due to various reasons (such as hemiparetic CP, brachial plexus or upper extremity developmental deficiency for any reason). CHEQ consists of 27 sub-items and evaluates quality aspects of movement in three different subscales, including the grasping efficiency of hand functions, the time required to perform the activity, and the feeling of discomfort caused by the affected hand during the performance of the activity. Change from baseline at 8 weeks
Primary Abilhand-Kids Abilhand-Kids scale evaluates hand functions in children with CP. It measures the use of the upper extremity during children's daily activities in 21 items. There are 3 points in the scoring: 0: cannot be done, 1: difficult, 2: easy. Change from baseline at 8 weeks
Primary Selective Control of the Upper Extremity Scale (SCUES) Selective Control of the Upper Extremity Scale (SCUES) is a measurement tool specifically designed for this area, developed to evaluate selective motor control of the upper extremity. It is a useful evaluation measure that is video-based and implemented in less than 15 minutes. The degree of selective motor control is determined for each joint as "normal selective motor control: 3 points, mildly reduced selective motor control: 2 points, moderately reduced selective motor control: 1 point, no selective motor control: 0 points". Change from baseline at 8 weeks
Primary Pediatric Quality of Life Inventory (PedsQL) 3.0 Cerebral Palsy Module Pediatric Quality of Life Inventory (PedsQL) 3.0 Cerebral Palsy (CP) Module was developed to evaluate CP-specific quality of life areas of children with CP between the ages of 2-18. The scale questions the degree of problems experienced by individuals in the last month. The 35-item module consists of seven subscales: daily activities (9 items), school activities (4 items), movement and balance (5 items), pain and suffering (4 items), fatigue (4 items), eating activities (5 items), speech and communication (4 items). Subscale scores are calculated by dividing the total score of the answered items by the number of answered items. A higher mean score on a subscale of a field indicates that there are fewer problems in that field and the quality of life is higher. Change from baseline at 8 weeks
Secondary Semmes Weinstein Monofilament Test (SWMT) Semmes Weinstein Monofilament Test (SWMT) is a tactile test battery recommended to evaluate tactile sensation in individuals with CP. The SWMT battery has five different thicknesses of monofilament ranging from 2.83 to 6.65. The evaluation starts with the thinnest (2.83) filament and continues until the monofilament that the individual begins to feel. Change from baseline at 8 weeks
Secondary Two-Point Discrimination Two-Point Discrimination is used to evaluate tactile perception in individuals with CP. It evaluates the ability to perceive and distinguish tactile stimuli applied from two different points at the same time. The evaluation starts from the widest gap (15 mm) and progresses to the narrowest gap (0 mm). The lowest distance range that the individual feels is recorded. Change from baseline at 8 weeks
Secondary Modified Ashworth Scale (MAS) Modified Ashworth Scale (MAS) is a test that evaluates the increase in muscle tone resulting from increased resistance during passive movement of the extremity. It is a 6-level spasticity measurement method scored in the range of 0-4. The higher the score, the greater the spasticity. Change from baseline at 8 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT05317234 - Genetic Predisposition in Cerebral Palsy N/A
Recruiting NCT05576948 - Natural History of Cerebral Palsy Prospective Study
Completed NCT04119063 - Evaluating Wearable Robotic Assistance on Gait Early Phase 1
Completed NCT03264339 - The Small Step Program - Early Intervention for Children With High Risk of Developing Cerebral Palsy N/A
Completed NCT05551364 - Usability and Effectiveness of the ATLAS2030 Exoskeleton in Children With Cerebral Palsy N/A
Completed NCT03902886 - Independent Walking Onset of Children With Cerebral Palsy
Recruiting NCT05571033 - Operant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy N/A
Not yet recruiting NCT04081675 - Compliance in Children With Cerebral Palsy Supplied With AFOs
Completed NCT02167022 - Intense Physiotherapies to Improve Function in Young Children With Cerebral Palsy N/A
Completed NCT04012125 - The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy N/A
Enrolling by invitation NCT05619211 - Piloting Movement-to-Music With Arm-based Sprint-Intensity Interval Training Among Children With Physical Disabilities Phase 1
Completed NCT04489498 - Comparison of Somatometric Characteristics Between Cerebral Palsy and Normal Children, Cross-sectional, Multi Center Study
Completed NCT03677193 - Biofeedback-enhanced Interactive Computer-play for Youth With Cerebral Palsy N/A
Recruiting NCT06450158 - Robot-assisted Training in Children With CP N/A
Completed NCT04093180 - Intensive Neurorehabilitation for Cerebral Palsy N/A
Completed NCT02909127 - The Pediatric Eating Assessment Tool
Not yet recruiting NCT06377982 - Human Umbilical Cord Blood Infusion in Patients With Cerebral Palsy Phase 1
Not yet recruiting NCT06007885 - Examining Capacity Building of Youth With Physical Disabilities to Pursue Participation Following the PREP Intervention. N/A
Not yet recruiting NCT03183427 - Corpus Callosum Size in Patients With Pineal Cyst N/A
Active, not recruiting NCT03078621 - Bone Marrow-Derived Stem Cell Transplantation for the Treatment of Cerebral Palsy Phase 1/Phase 2