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临床试验/NCT01989806
NCT01989806已完成不适用

Investigation on the Effect of Robotic-assisted Body Weight Supported Treadmill Training on Walking and Cardiopulmonary Recovery in Patients Suffering From Incomplete Spinal Cord Injury

Kowloon Hospital, Hong Kong1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2013年12月1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
发起方
入组人数
16
试验地点
1
主要终点
Change in Walking Index for Spinal Cord Injury version II from baseline to 8 weeks

研究概览

简要总结

Evidences showed that patients suffering from spinal cord injury (SCI) have poor mobility and higher chance to develop cardiopulmonary diseases, which leads to poor quality of life and shorter life expectancy. Different modalities were developed aiming at mobility restoration in SCI patients and robotic assisted body weight supported treadmill training is one of the latest technique in recent years. Yet there are scarce studies to investigate its effectiveness. The purpose of this study is to investigate the effectiveness of robotic-assisted body weight supported treadmill training on mobility and cardiopulmonary function of patients suffering from SCI by a randomized controlled trial.

80 patients suffering from incomplete SCI will be recruited for an 8-week training program. They will be randomized into either robotic assisted body weight supported treadmill training group or passive lower limb mobilization training group. The training effects will be measured by Walking Index for Spinal Cord Injury version II, lower extremity motor score, lower limb Modified Ashworth Scale, robotic gait system, gait analysis and gas analysis under sub maximal exercise stress test.

Through the study, we intent to find the effectiveness of robotic-assisted body weight support treadmill training on walking and cardiopulmonary recovery with patients suffering from incomplete spinal cord injury.

The hypothesis of the study is:

Compared to the control group, robotic-assisted body weight supported treadmill training leads to a greater improvement in walking ability and cardiopulmonary functioning.

详细描述

Participants will be recruited from the spinal cord rehabilitation unit of Physiotherapy Department of Kowloon Hospital. Subjects will be allocated into intervention group or control group by using sealed envelope and they will be blinded for their group allocation. All participants will undergo standard physiotherapy program, including mobilization and strengthening exercise of limbs, trunk stabilization training, wheelchair maneuver training and overground walking training. Based on this standard training program twice per week, 60 minutes per session, participants will receive an additional 30 minutes (exclude set-up time) of robotic-assisted body weight supported treadmill training (BWSTT) or control training based on their group allocation 3 times for 8 week. EMG biofeedback system will be applied to bilateral vastus lateralis muscles during training with audio feedback to promote active participation.

Outcome measures will be collected before the intervention and the subjects will be reassessed after finishing their 8 weeks of intervention. Outcome measures include Walking Index for Spinal Cord Injury version II, Spinal Cord Independence Measure version III, lower extremity motor score, Modified Ashworth Scale, L-stiff and L-force measured by Lokomat system, VO2 maximum, spirometry, and gait analysis (walking speed, heel-heel base support,bilateral stance duration, bilateral symmetry) The result of this study will provide useful information to enhance the clinical effectiveness of the management for spinal cord injury with the use of robotic assisted body weight supported treadmill training.

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 (Participant)

入排标准

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

入选标准

  • adult patient with age 18 or above
  • suffering from incomplete spinal cord injury with classification B, C or D under the International Standards for Neurological Classification of Spinal Cord Injury (ISNSCI)
  • lesion level above or at T12; acquired the injury not more than 24 months at the time of recruitment
  • traumatic or non-traumatic, non-progressive lesion
  • able to tolerate standing on tilt-table in 90 degrees for more than 30 minutes
  • able to walk with or without orthosis but requires manual assistance in walking.

排除标准

  • fracture of spine or lower limbs which is not yet stabilized
  • severe osteoporosis or at high risk of pathological fracture
  • symptomatic postural hypotension; cardiac disease which is not recommended for moderate intensity exercise
  • severe muscle spasticity over lower limbs
  • severe lower limbs fixed contractures
  • leg length discrepancy for more than 2 centimeters
  • body weight exceeding 135 kilograms

研究组 & 干预措施

Robotic-assisted body weight supported treadmill training

Active Comparator

Robotic assisted body weight supported treadmill training with conventional PT training

干预措施: Robotic-assisted body weight supported treadmill training (Lokomat V6, Hocoma AG, Switzerland) (Device)

Passive lower limbs mobilization training

Placebo Comparator

Passive lower limbs mobilization training with conventional PT training

干预措施: Passive lower limbs mobilization training (Motomed Vivo 2, RECK, Germany) (Device)

结局指标

主要结局

Change in Walking Index for Spinal Cord Injury version II from baseline to 8 weeks

时间窗: Baseline, 8 weeks

A validated mobility independence assessment tool for spinal cord injury (SCI) population (Burns, Delparte, Patrick, Marino, \& Ditunno, 2011). Subjects will be asked to walk on a 10-meter straight line and score will be given based on the use of walking aids, orthoses, manual assistance and distance covered.

次要结局

未报告次要终点

研究者

发起方
Kowloon Hospital, Hong Kong
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mr. Cheung Yu Yeung

Physiotherapist II

Kowloon Hospital, Hong Kong

研究点 (1)

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