Clinical Trial to Compare Conventional Multidisciplinary Gait Rehabilitation With the Atalante Self-balancing Walking System in Patients With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Timed 10-meters walk test (10-MWT),
研究概览
简要总结
This trial is a prospective, randomized, rater-blinded study (cRHB (N=30) vs RAGT (N=30)). For the control group, this protocol includes 24 one-hour sessions of cRHB training during 8 weeks three times per week, under the supervision of a qualified rehab team.
For the intervention group (RAGT) this protocol includes 24 one-hour sessions of RAGT during 8 weeks three times per week, under the supervision of a qualified rehab team.
Informed consent will be obtained from patients prior to inclusion in the study, which will be carried out in accordance with the Declaration of Helsinki.
详细描述
Aims
Primary Aim:
To compare the effect of Robot-Assisted Gait Training (RAGT) using the Atalante self-balance exoskeleton with conventional rehabilitation training (cRHB) for improving Walking speed measured by the Timed 10-meters walk test (10-MWT), considering a clinically relevant change an improvement of 20% of the velocity (m/s) with respect to the baseline assessment.
Secondary Aims:
- To compare the effect of RAGT using the Atalante self-balance exoskeleton with conventional Rehabilitation training (cRHB), for improving static balance, dynamic balance, mobility, and self-perception of gait impairment measured with:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The eligibility of the subjects from the neurorehabilitation and neurology outpatient clinics of the Multiple Sclerosis Center of Catalonia (Cemcat) will be evaluated.
And the blinded outcome assessor comes in for just one day to assess each individual, without any information about the therapy that was given to each patient.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Male or female, between 18 and 75 years of age.
- •Confirmed diagnosis of MS.
- •EDSS from 6.0 to 7.
- •Able to maintain the upright position on a daily basis.
- •Stable course of disease-modifying therapy over the past 6 months.
- •Clinical comorbidity asymptomatic (i.e., no underlying cardiovascular disease)
- •Height: between approximately 1.50 m. and 1.90 m.
- •Willingness to visit the Multiple Sclerosis Center of Catalonia (Cemcat) for testing and training.
- •Gait disorder conditioned by paresis or hemiparesis associated with ataxia or sensory problems.
- •Patient having given written consent.
- •Atalante is able to accommodate the following limb lengths:
- •Thigh: 380-460mm.
- •Distance between the ground and the joint space of the knee (to be measured while wearing the shoes they intend to wear with Atalante):
- •457-607mm for patient with an ankle dorsiflexion ≥ 16°
- •457-577mm for patient with an ankle dorsiflexion between 13° et 16°
- •457-567mm for patient with an ankle dorsiflexion between 10° et 13°
- •457-557mm for patient with an ankle dorsiflexion between 0° and 10°
- •Hip with less or equal to 460mm when seated.
- •Maximum weight: 90 kg.
排除标准
- •• Pregnancy.
- •Starting or switching from fampridine (Fampyra®) in the last 4 weeks.
- •Height and weight outside the secure standard of safe use, described in the safety guides.
- •Contraindications for Atalante training (eg, bone instability, history of osteoporosis or osteoporotic fractures).
- •Subjects under Corticosteroids treatment or relapse.
- •Changes in disease-modifying and symptomatic therapy for MS during the study period.
- •Subjects with psychiatric or cognitive comorbidities that may interfere with the trial.
- •Whose joint centers cannot be aligned Atalante's.
- •Ranges of motion below:
- •Knee: 5° extension, 110° flexion
- •Ankle: 0° dorsiflexion, 9° plantar flexion, 18° inversion and eversion
- •Hip: 115° flexion, 15° extension, 17° abduction, 10° adduction, 10°
- •medial rotation, 20° lateral rotation
- •Severe spasticity (greater than Ashworth 3) or uncontrolled clonus.
- •Severe concurrent medical diseases: infections, circulatory, heart or lung, pressure sores.
- •Active implantable medical device.
研究组 & 干预措施
Traditional Gait Rehabilitation training (tRHB
Participants randomize to receive a tRHB, will be trained 3 times per week, with an intensity of 40 to 60 minutes, and duration over 8-weeks. Progression will occur by increasing the session intensity weekly.
A standardized protocol based on the usual clinical practice of physiotherapy in people with multiple sclerosis will be follow, according to patient characteristics, to design the sessions based on the patient objectives to be achieved, choosing the type of specific exercises to be performed based on the patient's condition and with the possibility of adapting them to their evolution during the twenty-four sessions.
干预措施: tRHB (Other)
Robot Gait training (RAGT):
RAGT group, will be trained 3-times per week, with an intensity of 40 to 60 minutes, and duration over 8-weeks. Progression will occur by increasing the session intensity weekly. Training intensity will be monitored and standardized using the Borg Rating of Perceived Exertion scale, and will progress from 'fairly light' to 'somewhat hard'.
Progression will occur by increasing the number of steps in each session and decrease the level of assistance.
Participants will be secured with the appropriately sized harness and attached to an overhead body-weight support system. Each session will begin with a 3-5-minute warm-up in the continuous passive mode (cadence ~40-45 steps/minute). The participant will then be transitioned into the adaptive training phase for practicing repetitive floor walking for up to 30 minutes. During this phase, the force produced by the robot is modulated to support the effort of the patient in producing a typical walking pattern.
干预措施: Robotic gait training (Device)
结局指标
主要结局
Timed 10-meters walk test (10-MWT),
时间窗: 2 months
\- To compare the effect of RAGT by use of Atalante self-balance exoskeleton with conventional rehabilitation training (cRHB) for improving Walking speed measured by the Timed 10-meters walk test (10-MWT), considering a clinically relevant change an improvement of 20% of the velocity (m/s) with respect to the baseline assessment.
次要结局
未报告次要终点
研究者
Edwin Roger Meza Murillo
Principal Investigator
Multiple Sclerosis Center of Catalonia