跳至主要内容
临床试验/NCT05350241
NCT05350241已完成不适用

Exploring Temporospatial Gait Asymmetry, Dynamic Balance, and Locomotor Capacity After a 12-month Split-belt Treadmill Training in Adolescents With Unilateral Cerebral Palsy: A Randomized Clinical Study

Cairo University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2021年1月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
1
主要终点
Temporal gait asymmetry index

研究概览

简要总结

This study was designed to investigate the effect of repeated split-belt treadmill waking practice on gait symmetry, dynamic balance control, and locomotor capacity in adolescents with unilateral cerebral palsy (ULCP). Fifty-two children with ULCP were randomly allocated to the split-belt treadmill walking (n = 26; undergone split-elt treadmill training or the Control group (n =23, received standard rehabilitation program). Both groups were assessed for gait symmetry, dynamic balance control, and locomotor capacity pre and post-treatment.

详细描述

Fifty-two children with ULCP were recruited from the Physical Therapy Outpatient Clinic of the College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, King Khalid Hospital, and a tertiary referral hospital, Al-Kharj, Saudi Arabia. Their age ranged between 10 and 16 years, were functioning at levels I or II according to the Gross Motor Function Classification System, and had spasticity levels 1 or 1+ per the Modified Ashworth Scale. Children were excluded if they had fixed deformities, underwent neuromuscular or orthopedic surgery in the last 12 months, submitted to BOTOX injection in the past 6 months, had attentional neglect, and if they had cardiopulmonary problems that could be exacerbated by exercise.

Outcome measures

  1. Gait-symmetry Indices: Gait symmetry indices (Spatial and temporal) were measured through the portable GAITRite system.
  2. Dynamic balance: The directional dynamic limit of stability (forward, backward, paretic, and non-paretic) and overall limit of stability were assessed using the Biodex balance system.
  3. Locomotor capacity: This was assessed through the 6-minute walk test (6-MWT), the Timed Up and Down Stair test (TUDS), and the 10-meter Shuttle Run Test (10mSRT).

Both groups were trained for one hour, three times a week, for 12 successive weeks. The split-belt treadmill walking group performed repetitive split-belt treadmill training with an error-augmentation strategy (i.e., exaggeration of the initial step-length asymmetry). The control group received the standard rehabilitation program, which comprised advanced balance training, and gait training exercises, postural and flexibility exercises, strength training exercises.

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
Single (Outcomes Assessor)

盲法说明

This was a single-blind protocol. The researcher who collected the data was blinded to the treatment allocation.

入排标准

年龄范围
10 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Unilateral cerebral palsy
  • Age 10-16 years
  • Motor function level I or II according to the Gross Motor Function Classification System.
  • Spasticity level 1 or 1+ according to the Modified Ashworth Scale

排除标准

  • Structural deformities/contractures
  • Musculoskeletal or neural surgery in the last year
  • BOTOX injection in the last 6 months.
  • Cardiopulmonary disorders that could be exacerbated by exercise.
  • Perceptual and/or behavioral disorders.

结局指标

主要结局

Temporal gait asymmetry index

时间窗: 2 months

was measured about the single-limb support time of the paretic and non-paretic leg The temporal gait asymmetry index through the portable GAITRite system. Lower scores indicate a more symmetrical pattern.

Spatial gait asymmetry index

时间窗: 2 months

The spatial gait asymmetry index was measured about the step length of the paretic and non-paretic leg through the portable GAITRite system. Lower scores indicate a more symmetrical pattern.

Dynamic limit of postural stability

时间窗: 2 months

The capacity to control and move the center of gravity in various directions across their base of support was assessed utilizing the Biodex balance system. Values are expressed as accuracy % and higher scores mean better balance capability.

次要结局

  • Six-minute walk test(2 months)
  • Timed Up and Down Stair test(2 months)
  • 10-meter Shuttle Run Test(2 months)

研究者

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

Ragab Kamal Elnaggar

Associate Professor

Cairo University

研究点 (1)

Loading locations...

相似试验

Repetitive Split-Belt Treadmill Perturbation in... | 临床试验