Effect of Visually-Guided Gait Training on Balance, Mobility and Risk of Falling in Patients With Multiple Sclerosis: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Dynamic Balance Performance (%):
研究概览
简要总结
The aim of this study is to assess both immediate and long-term effects of visually-guided gait training on balance, mobility, and risk of falling in patients with multiple sclerosis.
详细描述
Balance and mobility impairments are the most common deficits in people with multiple sclerosis (MS), arising early in the disease course and gradually progressing over time, leading to loss of independence and quality of life. Moreover, static, and dynamic balance deficits in MS patients have been demonstrated to play a major role in patients' perception of walking ability during daily life and in predicting future falls. Given the strong impact of balance impairments on MS patients' disability.
Also, it was reported that the ability to coordinate visual information with movement is normally important to interact with the environment. Indeed, visually guided walking requires the brain to maintain an accurate relationship (or visuomotor mapping) between the perceived stepping location and the motor command necessary to direct the foot to that position on the ground with minimal error. Besides, previous research reported that people with MS, with neuronal transmission impairment or lesions on somatosensory ways, are more dependent on visual compensation for maintain balance. As lesions on somatosensory ways alter postural stability as this fundamental feedback is impaired, making a postural compensation and the visual feedback often more necessary to maintain balance.
To overcome these highly disabling issues, different rehabilitative approaches have been proposed so far in the literature. However, rehabilitation interventions in individuals with MS are limited to aerobic, resistance, and combined aerobic and resistance exercises and instrumental adapted exercise modalities including body-weight-supported treadmill walking or robotic technology. Few studies have addressed the effects of external sensory stimulations (visual, auditory) during gait training on motor performance in patients with multiple sclerosis.
So, visually-guided gait training could be beneficial for improvement of balance and mobility measures and decrease risk of falling for people with MS.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 开放(无盲法)
入排标准
- 年龄范围
- 20 Years 至 45 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Clinically definite MS (relapsing and remitting) patients who are stable for at least three months.
- Expanded Disability Status Scale (EDSS) score of ≤ 4 (fully ambulatory, self-sufficient, and able to stand and walk without any aid or orthosis at least 500 meters) to minimize the impact of motor weakness interfering with their ability to perform the task.
- Normal or corrected to normal vision, wearing eyeglasses.
- The age will range from 20 - 45 years.
- All patients with MS were required to report subjective perceived imbalance or history of falls (in the last year)
排除标准
- Patients with any other neurological deficits or orthopedics abnormalities.
- Patients with secondary musculoskeletal complications such as fractures, contractures, or deformities.
- Patients with vision problems that impaired walking ability.
- Patients with severe cognitive impairment or psychological disorders impaired the ability to follow the procedures of the study.
- Patients with cardiovascular and respiratory diseases.
- Patients with serious unstable medical condition or Patients had an acute exacerbation of MS within last month.
- Pregnant women.
研究组 & 干预措施
Visually-guided gait training + Conventional gait training
This group will consist of twenty patients, who will receive visually-guided gait training and conventional gait training for 8 weeks.
干预措施: Visually-guided gait training (Other)
Visually-guided gait training + Conventional gait training
This group will consist of twenty patients, who will receive visually-guided gait training and conventional gait training for 8 weeks.
干预措施: Conventional gait training (Other)
Conventional gait training
This group will consist of twenty patients, who will receive conventional gait training only for 8 weeks.
干预措施: Conventional gait training (Other)
结局指标
主要结局
Dynamic Balance Performance (%):
时间窗: 8 weeks and follow up after 4 weeks.
The percentage score representing how accurately the participant maintained the red spot path within the designated frame during the dynamic balance test. A higher percentage indicates better balance control and greater stability.
Front Average Deviation
时间窗: 8 weeks and follow up after 4 weeks
The mean displacement of the participant's center of pressure (COP) in the forward (anterior) direction.
Back Average Deviation
时间窗: 8 weeks and follow up after 4 weeks
The mean displacement of the participant's center of pressure (COP) in the backward (posterior) direction.
Right Average Deviation
时间窗: 8 weeks and follow up after 4 weeks
The mean displacement of the participant's center of pressure (COP) in the right (lateral) direction.
Left Average Deviation
时间窗: 8 weeks and follow up after 4 weeks
The mean displacement of the participant's center of pressure (COP) in the left (lateral) direction.
次要结局
- The Four-Square Step Test (FSST)(8 weeks and follow up after 4 weeks)
- The Ten-Meter Walk Test (10MWT)(8 weeks and follow up after 4 weeks)
- Arabic version of Falls Efficacy Scale-International (FES-I)(8 weeks and follow up after 4 weeks)
- The Four-Square Step Test (FSST)(8 weeks and follow up after 4 weeks)
- The Ten-Meter Walk Test (10MWT)(8 weeks and follow up after 4 weeks)
- Arabic version of Falls Efficacy Scale-International (FES-I)(8 weeks and follow up after 4 weeks)
研究者
研究点 (2)
标识符
- NCT 编号
- NCT07233044
- 其他研究编号
- P.T.REC/012/005505
日期
- 首次提交
- (10个月前)
- 首次发布
- (10个月前)
- 主要完成日期
- (5个月前)
- 研究完成日期
- (5个月前)
- 最近核实
- (11个月前)
- 最近更新
- (3个月前)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否
