A Study to compare the Outcomes of Home Based and Supervised Individually Designed Exercise Programme for Patients in Chronic Phase after Guillain Barre Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Functional impairment measurement
研究概览
简要总结
Guillian Barre syndrome (GBS) is an immune mediated disorder of peripheral nervous system of acute or sub acute onset. It is most commonly characterized by combination of generalized weakness paresthesias of limbs, and areflexias with incidence rate of 1 to 2 per 100,000 population.The treatment of GBS aims to accelerate recovery, reduce complication in acute phase of illness and decrease the amount of long term neurological residual disability. The progression of the disease depends upon its severity at onset. It suddenly progress to severely disabling paralysis of the limbs with in few days of onset and the disease severity reaches it peaks in two to three weeks in about 50% and 80% of cases respectively. The disease starts its recovery after two – four weeks leaving almost 20% of the patients disabled even after the treatment especially in ambulation. At present there is a scarcity of information on the effectiveness of the physiotherapy intervention in GBS as there is only one Randomized Control Trial (RCT) and two Systemic Reviews(SR) on multi-disciplinary (MD) and the review did not identified any RCT, SR, Clinical Control Trial or on physiotherapy which is the integral part of the treatment. GBS is not the disease to be treated in one day. It requires a long term physiotherapy rehabilitation and require the designing of specialized programme and active patient participation. There is a strict need of RCT in this field so as to evaluate the need of physiotherapy in GBS, effect of exercises in improving the functional outcome and to develop the exercise protocols for the patients and to make them independent in their functional status and activities of daily living.Objectives:
· To evaluate the functional independence of the patients with chronic phase after Guillain Barre Syndrome (pwGBS) after home based exercise programme as compared to supervised individually designed exercise programme .
· To evaluate the outcomes of the pwGBS patients in terms of fatigue, muscle power, pain, activities of daily living (ADL) and quality of life (QoL) after home based exercise programme as compared to supervised individually designed exercise programme
Hypothesis:
“We hypothesize that the supervised individually designed exercise programme would perform better than home based exercise program in achieving the outcomes of interest.â€
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients above 18 years of age of “definite†GBS diagnosed through World Health Organization of International Classification of Disease, having current stable medical course within last five years and all new cases, confirmed by physician/neurologists.
- •We shall include only those participants who have a physical disability as assessed by the International Classification of Impairment, Disability and Handicap (WHO 1980) was updated by the World Health Organization to the International Classification of Functioning, Disability and Health (WHO 2001), as an international standard to describe health and disability Clinical judgement of the assessing physician/ physiotherapist regarding potential benefits of the physiotherapy programme to the individual.
- •All variants of GBS will be included in the study.
排除标准
- •Patient those who have received the physiotherapy treatment in the period of previous 6 months.
结局指标
主要结局
Functional impairment measurement
时间窗: At the time of recruitment, at six months, at 12 months
次要结局
- Fatigue Severity Scale,MRC manual muscle testing, Visual analog scale for pain, Barthel Index for activities of daily living, World Health Organization Quality of Life(at the time of recruitment, at six months, at 12 months)