Cerebral Palsy Clinical Trial
— cpOfficial title:
Validity and Reliability of the Timed 360° Turn Test in Children With Cerebral Palsy
NCT number | NCT05213039 |
Other study ID # | KSUFTR1 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 15, 2022 |
Est. completion date | March 15, 2024 |
Verified date | March 2024 |
Source | Kahramanmaras Sutcu Imam University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Cerebral Palsy (CP) is a non-progressive neurodevelopmental disorder that starts in the early stages of life, causes activity limitation, and consists of movement and posture deficiencies. Children with CP usually have difficulties in mobility, transfer and social participation due to many motor and sensory disorders such as muscle weakness, decreased postural control, balance, spasticity. Many children with CP have difficulty in balancing independently, walking, walking on hills/uneven ground, and performing daily physical functions.
Status | Completed |
Enrollment | 91 |
Est. completion date | March 15, 2024 |
Est. primary completion date | March 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 7 Years to 18 Years |
Eligibility | Inclusion Criteria: - Having been diagnosed with CP according to SCPE criteria - Level = 2 by GMFCS-E&R - Children aged 7-18 with CP with a Communication Function Classification System (CFCS) = 3 - Children with a Modified Ashworth Scale (MASH) = 3 - Passive range of motion in the ankle, knee and hip joints - Individuals with spastic hemiparetic-diparetic CP who can follow verbal commands - Volunteer to participate in the study Exclusion Criteria: - Have not had Botox, (Botulinum toxin) or surgery in the last 6 months - Contracture of ankle and knee joint - Individuals with hemiparetic-diparetic CP who can follow verbal commands |
Country | Name | City | State |
---|---|---|---|
Turkey | Kahramanmaras Sutcu Imam University | Kahramanmaras |
Lead Sponsor | Collaborator |
---|---|
Kahramanmaras Sutcu Imam University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the timed 360° turn test | In the timed 360° turn test, any marker, such as a tape or pen, is used to determine the starting point and a stopwatch is used to measure time. Each participant stands up comfortably at the starting point and rotates 360° for both sides. The time begins with the word "begin" and ends when the participants' shoulders look forward again. Each participant completes. The average of 3 trials and 3 trials for each side yields a result. The average score is recorded for the timed 360° turn test performance. | two different observers' measurements in 2 different days (2 sessions per day on two separate days) | |
Primary | Four Square Step Test (FSST) | The child stands in square 2 facing square 1 in a marked area divided into 4 squares. The child has to take turns stepping on each square as fast as possible: it requires the child to step forward, backward, right, and left in a sequence of 2, 3, 4, 1, 4, 3, 2, and 1, respectively. The necessary equipment is a stopwatch and 4 walking sticks 90 cm long. A square with 4 is formed by laying the canes flat on the ground. If the child cannot complete the series, loses balance or touches the cane during the trial, the trial is repeated.Two FSSTs are completed with the best time taken as a score.Timing begins with the first foot touching the floor in frame 1 and ends with the last foot touching the floor in frame 4. Test performance is measured in seconds (sec) and shorter completion time means better dynamic stability. | first day of assessment | |
Primary | Pediatric Berg Balance Scale (PBBS) | The test has 14 items of increasing difficulty to test functional skills related to activities of daily living, from sitting to standing on one leg. Each item is scored on a five-point ranking scale ranging from 0 to 4 points, with a maximum score level of 56. A higher score indicates better postural balance. | first day of assesment | |
Primary | Timed Up and Go Test (TUG) | For the test, the child is seated in a height-adjustable chair. The chair height is adjusted so that the child's feet are in contact with the floor and the knees and hips are flexed to 90 degrees. A distance of 3 meters is marked. When the command is given, the child is asked to get up, walk, return and sit on the chair until the marked area. By starting the time with the start command, the time until sitting is recorded. This test will be repeated 3 times and the average time will be recorded. Increasing time indicates worse dynamic stability. | first day of assesment | |
Primary | Pediatric Functional Reach test | The child is asked to stand sideways on a wall, with the elbows extended at 90 degrees of shoulder flexion without touching the wall. The first measurement is made in this position. Then, he is asked to reach forward without taking a step. The last point it can reach is recorded. The distance between these two distances is measured in meters and recorded. The test is repeated when stepping or stopping the contact of the foot with the ground. A higher measurement indicates worse balance. | first day of assesment | |
Secondary | Expanded and revised Gross Motor Function Classification System (GMFCS-E&R) | It is a standard classification system used to classify gross motor functions of children with CP. GMFCS-E&R classifies levels I to V. Level I indicates the best and V the worst level of motor function. | first day of assessment | |
Secondary | Modified Ashworth Scale (MASH) | It is a method used to determine the severity of spasticity. It is based on the subjective rating of the resistance felt during the examination. Spasticity of the bilateral hip adductors, hip flexors, knee flexors, ankle plantar flexors (gastro-solues) muscles in the lower extremity will be evaluated once at the beginning of the treatment program. The tone felt in these muscles against passive movement is classified as follows; 0: No increase in tone, 1: Slight increase in tone characterized by catching and relaxation or mild resistance at the end of the ROM, 1+: Slight increase in tone characterized by minimal resistance in the remaining ROM (less than half) after capture, 2: Significant tone over most of the ROM increase, but the involved joint can be moved easily, 3: Significant increase in muscle tone, passive movement is difficult, 4: The involved part is rigid in flexion or extension. | first day of assessment | |
Secondary | Demographic information of the children | age, height, gender, education level, background of physiotherapy and diagnosis will be recorded. | first day of assessment |
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