Clinical Trials Logo

Clinical Trial Summary

This study aimed to evaluate the effect of treadmill training (TT) at different inclinations on balance, strength, flexibility, and gait parameters in children with cerebral palsy (CP) in addition to traditional physiotherapy applications. Forty-two participants with CP aged 7-18 years and at Gross Motor Function Classification System level 2 were randomized into three groups: downhill walking (DW), uphill walking (UW), and walking with no incline (WWI). Balance, isometric strength, flexibility, and gait parameters were assessed at baseline (2nd week) and at 11th week. The groups were provided with TT and conventional treatment. All groups showed improvement in balance. Isometric strength values showed improvement in knee flexion (KF) on the affected side (AS) in DW and UW groups, and in knee extension force in UW and WWI groups. In flexibility, hip flexion, hip extension and ankle dorsiflexion improved in all groups, while KF and ankle plantar flexion improved only in DW and WWI. Duration of the modified timed up-and-go test showed significant improvements in the DW and UW groups. TT performed at different inclinations improved balance, isometric strength, flexibility, and gait parameters on both the AS and the nonaffected side.


Clinical Trial Description

TT is a therapeutic technique in the rehabilitation of children with CP. Positive effects of different TT protocols have been observed in patients with CP; however, there is no study examining the effects of forward downhill TT. Therefore, this study aimed to investigate the effect of TT with forward downhill walking (DW), forward uphill walking (UW), and forward walking with no incline (WWI) on balance, strength, flexibility, and gait parameters in 7-18-year-old children with hemiparetic and diparetic CP in addition to traditional physiotherapy applications. Sixty-four participants were initially recruited in this study. However, 42 participants (18 female, 24 male) with hemiparetic and diparetic CP completed the study. The study was conducted in a Special Education and Rehabilitation Center in Denizli, Turkey between April 2021 and June 2022. The inclusion criteria for the study were (a) age between 7-18 yrs old, (b) being at Gross Motor Functional Classification System (GMFCS) levels II, (c) no cooperation problems that would interfere with communication, (d) no surgical treatment or neuromuscular injection in the last 6 months (e) no unstoppable epileptic seizures, (f) asymmetric lower extremity shortness >4 cm and no any health problems except CP. Exclusion criteria from the study were trauma during the study period, not participating in the exercise program by more than 20%, willing to quit voluntarily, having a spasticity ≥2 on the Modified Ashworth Scale (MAS) measured from the lower extremity All parents/guardians agreed to the participation of their children by signing a statement of informed consent. The investigation was approved by the Pamukkale University Clinical Research Ethics Committee (60116787-020-35801/24.03.2021). All procedures were realized in according to the Declaration of Helsinki. To ensure that the gender and age distributions to be observed in the groups were similar, a randomization table was prepared by stratified randomization method before the study. All participants received a conventional physiotherapy program for 2 days/week, 40 min/day for 8 weeks. In addition to this program, the first group performed DW TT, the second group performed UW TT, and the third group performed WWI TT walking exercise on the treadmill for 2 days/week, 30 min/day on different days. At the beginning and end of the 8-week program, the participants' lower extremity isometric strength was assessed using a hand-held dynamometer, dynamic balance was assessed using a functional reach test (FRT), flexibility was assessed range of motion (ROM) using a goniometer, and gait performance was assessed using a spatiotemporal gait analyzer. All measurements included familiarization trials. Conventional physiotherapy program, walking exercises, and measurements were conducted in standard conditions (22-25 °C, 25%-45% relative humidity) during the morning hours in a quiet room by the same physiotherapist. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06216652
Study type Interventional
Source Pamukkale University
Contact
Status Completed
Phase N/A
Start date November 10, 2021
Completion date March 10, 2022

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