跳至主要内容
临床试验/NCT06216652
NCT06216652已完成不适用

Enhancing Balance, Strength, Flexibility and Spatiotemporal Gait Parameters in Pediatric Cerebral Palsy: Treadmill Training at Variable Inclinations

Pamukkale University1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2021年11月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
1
主要终点
Balance

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
7 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • age between 7-18 yrs old,
  • being at Gross Motor Functional Classification System (GMFCS) levels II,
  • no cooperation problems that would interfere with communication,
  • no surgical treatment or neuromuscular injection in the last 6 months
  • no unstoppable epileptic seizures,
  • asymmetric lower extremity shortness >4 cm and no any health problems except CP.

排除标准

  • 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

研究组 & 干预措施

downhill walking

Active Comparator

All participants received a conventional physiotherapy program. In addition to this program, the first group performed downhill walking exercise on the treadmill

干预措施: downhill walking (Other)

uphill walking

Active Comparator

All participants received a conventional physiotherapy program. In addition to this program, the second group performed uphill walking exercise on the treadmill

干预措施: uphill walking (Other)

walking with no incline

Active Comparator

All participants received a conventional physiotherapy program. In addition to this program, the third group performed walking with no incline exercise on the treadmill

干预措施: walking with no incline (Other)

结局指标

主要结局

Balance

时间窗: 8 weeks

Dynamic balance was assessed using the functional reach test (FRT), one of the physical fitness parameters, which is a reliable and valid assessment tool for assessing balancing ability among children with CP. The results were recorded in centimeters and statistics were made on their averages.

Isometric muscle strength

时间窗: 8 weeks

The isometric muscle strength, one of the physical fitness parameters, is a reliable assessment tool for assessing isometric strength among children with CP. The isometric muscle strength of the participants' knee flexor and extensor muscles was evaluated with a hand dynamometer (JTECH Medical PowerTrack II Commander, Salt Lake City, UT, USA). The results were recorded in newton and statistics were made on their averages.

Spatiotemporal gait analysis

时间窗: 8 weeks

Gait performance, one of the physical fitness parameters, was assessed with the LEGSystm spatiotemporal gait analyzer (LegSys/BioSenics, Watertown, USA). The results were recorded as time (s and min), distance (m) and step frequency (step/min), and statistics were made on their averages.

Flexibility

时间窗: 8 weeks

Range of motion measurements, one of the physical fitness parameters, were performed manually with a goniometer. The results were recorded in degree and statistics were made on their averages.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Berna Ramanli

assistant professor

Pamukkale University

研究点 (1)

Loading locations...

相似试验