The Effect of High Tone Power Therapy on Fatigue and Functional Outcomes in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Expanded Disability Status Scale (EDSS)
研究概览
简要总结
To investigate the effect of "High Tone Power Therapy" (HTPT) on fatigue and functional outcomes in multiple sclerosis (MS). BACKGROUND: Fatigue and functional limitations considered serious disorders in patients with multiple sclerosis that lead to impairment of the physical activities and disruption of the quality of life (QOL).
HYPOTHESES:
This study hypothesized that:
High Tone Power Therapy will have a significant beneficial effect on fatigue and functional outcomes in in multiple sclerosis
RESEARCH QUESTION:
Is there a beneficial effect of High Tone Power Therapy on fatigue and functional outcomes in multiple sclerosis?
详细描述
Double blind randomized study including 40 patients with MS. The patients will be randomly allocated into 2 arms: active arm and placebo arm; in the active arm patients will receive "high tone power therapy" in addition to the physical therapy conventional selected exercise program, and the placebo arm will receive the same physical exercise program with sham "high tone power therapy". Either program will be applied 3 times per week for 4 weeks.
The evaluation methods will be done using:
- Expanded Disability Status Scale (EDSS) / Functional Systems Score (FSS),
- Fatigue severity scale and Modified Fatigue Impact Scale. before the exercise program and after finishing the exercise program, The assessor of the patients, before and after the program, will be blinded to the technique used (whether active or sham).
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
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both genders
- •Age from 18-50 years
- •All MS types will be included (relapsing remitting "RR", secondary progressive "SP, and primary progressive "PP")
- •Patients with residual motor / cerebellar / sphincteric impairment that are not responding to conventional pharmacological treatments.
- •At least 6 months after the last relapse.
- •EDSS from 2-6.
- •All patients should be receiving a disease modifying therapy with stabilization of the disease course for 1 year in case of SPMS and PPMS.
- •Patients that can pay regular visits to the physical center without potential interruption.
- •Patients who agree to participate and sign the informed consent. - body mass index (20:29) kg/m2
排除标准
- •cognitive impairment that can hinder the ability to communicate or to understand program instructions.
- •neurological deficits due to any disease other than MS
- •orthopedic abnormalities,
- •secondary musculoskeletal complication.
- •Patients who refuse participation or signing the informed consent.
研究组 & 干预措施
study group
in the active arm patients will receive "high tone power therapy" in addition to the physical therapy conventional selected exercise program
干预措施: High Tone Power Therapy (Device)
study group
in the active arm patients will receive "high tone power therapy" in addition to the physical therapy conventional selected exercise program
干预措施: exercise program (Other)
control group
the sham arm will receive the same physical exercise program with sham "high tone power therapy".
干预措施: exercise program (Other)
结局指标
主要结局
Expanded Disability Status Scale (EDSS)
时间窗: 4 weeks
The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. It is widely used in clinical trials and in the assessment of people with MS. The scale was developed by a neurologist called John Kurtzke in 1983 as an advance from his previous 10 step Disability Status Scale (DSS). The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist. EDSS steps 1.0 to 4.5 refer to people with MS who are able to walk without any aid and is based on measures of impairment in eight functional systems
Functional Systems Score (FSS),
时间窗: 4 weeks
On a scale of 0 to 6, the functional system score (FSS) measures how well the major central nervous systems are working and assigns a score to the patient disability. This score uses also information about the gait and use of assistive devices.
次要结局
未报告次要终点
研究者
Lama Saad El-Din Mahmoud
Lecturer of physical therapy, Department of Neuromuscular disorders and its surgery
October 6 University