Placebo Controlled, Randomized, Double Blind, Clinical Trial of the Effects of Low Frequency Magnet Therapy on Spasticity in Patients With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 主要终点
- Change from baseline Cerebral Palsy Quality of Live Questionnaire (Access to services dimension) at 4, 8 and 12 weeks
研究概览
简要总结
Background: Spasticity is a major challenge in patients with cerebral palsy (CP). It may cause unwanted complications and may affect the patient's quality of life. Currently there is no satisfactory long lasting control of spasticity. Many lines of evidence indicate that magnet therapy may be a useful intervention in the management of spasticity. Several studies showed that magnet may inhibit neuronal firing in the human nervous system; however, its effects weren't studied on spasticity. Objectives: The goal of the present study was to determine the short-and long-term effects of pulsed low frequency magnetic field therapy on spasticity in patient with CP. Methods: 48 patients with CP, who have measureable level of spasticity, were selected. The sample was divided randomly into active magnet group (received magnet therapy, 32 subjects) and placebo group (16 subjects). At the end of the 4th week the magnet group was divided into two sub-groups: 1st sub-group received magnet therapy for another 4 weeks while the other received the placebo. Measurements was taken at baseline, 4th, 8th and 12th weeks. Modified Ashworth Scale was used to measure spasticity, foot pressure platform system was used to measure the contact area and the maximum force of the feet, gross motor function measure (GMFM) was used to measure the functional level of the patients. The cerebral palsy quality of life (CP-QoL) questionnaire was used to measure the patients' various dimensions of quality of life.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A confirmed diagnosis of diplegic or quadriplegic CP of both genders,
- •Able to stand without assistance.
- •Age from 4-16 years
- •Measureable spasticity (1 or more according to the Modified Ashworth Scale).
排除标准
- •Have recent organ transplants.
- •Have heart pace maker.
- •Have cardiac arrhythmia, tachy cardiac conditions or large aneurysm.
- •Have heavy psychosis.
- •Underwent any neuromuscular blockers of Spasticity.
- •Underwent any surgery of tendon lengthening before or during the study.
- •Have epileptic episodes.
结局指标
主要结局
Change from baseline Cerebral Palsy Quality of Live Questionnaire (Access to services dimension) at 4, 8 and 12 weeks
时间窗: baseline, 4th week, 8th week and 12th week
1. Items numbers in the questionnaire: (41, 42, 43, 53, 54, 55, 56, 57, 58, 59, 60, 61). 2. Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy. 3. To be calculated by summation of all the dimension's score. 4. Higher score means better outcome.
Comparison of Cerebral Palsy Quality of Live Questionnaire (Access to services dimension) scores between the three groups from baseline at 4, 8 and 12 weeks
时间窗: baseline, 4th week, 8th week and 12th week
1. Items numbers in the questionnaire: (41, 42, 43, 53, 54, 55, 56, 57, 58, 59, 60, 61). 2. Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy. 3. To be calculated by summation of all the dimension's score. 4. Higher score means better outcome.
Change from baseline Feet Contact Area at 4, 8 and 12 weeks
时间窗: baseline, 4th week, 8th week and 12th week
The weight distribution between the feet and the ground - Higher grade means better outcome
Change from baseline Cerebral Palsy Quality of Live Questionnaire (Functioning dimension) at 4, 8 and 12 weeks
时间窗: baseline, 4th week, 8th week and 12th week
1. Items numbers in the questionnaire: (8,22,23,24,27,29,34,35,37,38,39,40). 2. Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy. 3. To be calculated by summation of all the dimension's score. 4. Higher score means better outcome
Comparison of Feet Contact Area scores between the three groups from baseline at 4, 8 and 12 weeks
时间窗: baseline, 4th week, 8th week and 12th week
The weight distribution between the feet and the ground - Higher grade means better outcome
Comparison of Cerebral Palsy Quality of Live Questionnaire (Emotional well-being dimension) scores between the three groups from baseline at 4, 8 and 12 weeks
时间窗: baseline, 4th week, 8th week and 12th week
1. Items numbers in the questionnaire: (2,28,31,32,33,52). 2. Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy. 3. To be calculated by summation of all the dimension's score. 4. Higher score means better outcome.
Comparison of Cerebral Palsy Quality of Live Questionnaire (Family health dimension) scores between the three groups from baseline at 4, 8 and 12 weeks
时间窗: baseline, 4th week, 8th week and 12th week
1. Items numbers in the questionnaire: (62, 63, 64, 65). 2. Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy. 3. To be calculated by summation of all the dimension's score. 4. Higher score means better outcome.
Change from baseline Feet Maximum Force at 4, 8 and 12 weeks
时间窗: baseline, 4th week, 8th week and 12th week
Measuring Feet Maximum Force of the participants - Higher grade means better outcome
Comparison of Cerebral Palsy Quality of Live Questionnaire (Social well-being and acceptance dimension) scores between the three groups from baseline at 4, 8 and 12 weeks
时间窗: baseline, 4th week, 8th week and 12th week
1. Items numbers in the questionnaire: (1,3,4,5,6,7,10,11,12,13,14,15). 2. Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy. 3. To be calculated by summation of all the dimension's score. 4. Higher score means better outcome
Comparison of Cerebral Palsy Quality of Live Questionnaire (Pain and impact of disability dimension) scores between the three groups from baseline at 4, 8 and 12 weeks
时间窗: baseline, 4th week, 8th week and 12th week
1. Items numbers in the questionnaire: (44, 45, 46, 47, 48, 49, 50, 51). 2. Each item has an answer from one to nine; where (1= not bothered at all) to (9 = very bothered). 3. To be calculated by summation of all the dimension's score. 4. Higher score means worse outcome.
Change from baseline Modified Ashowreth Scale at 4, 8 and 12 weeks
时间窗: baseline, 4th week, 8th week and 12th week
measure the muscle resistance following a passive stretch - grades from (0 - 4), lower score means better outcome
Change from baseline Gross Motor Function Scale at 4, 8 and 12 weeks
时间窗: baseline, 4th week, 8th week and 12th week
to evaluate the children with CP according to their motor functional ability - Scores (0% - 100%) where higher grade means better outcome.
Change from baseline Cerebral Palsy Quality of Live Questionnaire (Social well-being and acceptance dimension) at 4, 8 and 12 weeks
时间窗: baseline, 4th week, 8th week and 12th week
1. Items numbers in the questionnaire: (1,3,4,5,6,7,10,11,12,13,14,15). 2. Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy. 3. To be calculated by summation of all the dimension's score. 4. Higher score means better outcome
Change from baseline Cerebral Palsy Quality of Live Questionnaire (Emotional well-being dimension) at 4, 8 and 12 weeks
时间窗: baseline, 4th week, 8th week and 12th week
1. Items numbers in the questionnaire: (2,28,31,32,33,52). 2. Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy. 3. To be calculated by summation of all the dimension's score. 4. Higher score means better outcome.
Comparison of Cerebral Palsy Quality of Live Questionnaire (Participation and physical health dimension) scores between the three groups from baseline at 4, 8 and 12 weeks
时间窗: baseline, 4th week, 8th week and 12th week
1. Items numbers in the questionnaire: (9,16,17,18,19,20,21,25,26,30,37). 2. Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy. 3. To be calculated by summation of all the dimension's score. 4. Higher score means better outcome
Change from baseline Cerebral Palsy Quality of Live Questionnaire (Participation and physical health dimension) at 4, 8 and 12 weeks
时间窗: baseline, 4th week, 8th week and 12th week
1. Items numbers in the questionnaire: (9,16,17,18,19,20,21,25,26,30,37). 2. Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy. 3. To be calculated by summation of all the dimension's score. 4. Higher score means better outcome
Change from baseline Cerebral Palsy Quality of Live Questionnaire (Pain and impact of disability dimension) at 4, 8 and 12 weeks
时间窗: baseline, 4th week, 8th week and 12th week
1. Items numbers in the questionnaire: (44, 45, 46, 47, 48, 49, 50, 51). 2. Each item has an answer from one to nine; where (1= not bothered at all) to (9 = very bothered). 3. To be calculated by summation of all the dimension's score. 4. Higher score means worse outcome.
Change from baseline Cerebral Palsy Quality of Live Questionnaire (Family health dimension) at 4, 8 and 12 weeks
时间窗: baseline, 4th week, 8th week and 12th week
1. Items numbers in the questionnaire: (62, 63, 64, 65). 2. Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy. 3. To be calculated by summation of all the dimension's score. 4. Higher score means better outcome.
Comparison of Modified Ashowreth Scale scores between the three groups from baseline at 4, 8 and 12 weeks
时间窗: baseline, 4th week, 8th week and 12th week
measure the muscle resistance following a passive stretch - grades from (0 - 4), lower score means better outcome
Comparison of Gross Motor Function Scale scores between the three groups from baseline at 4, 8 and 12 weeks
时间窗: baseline, 4th week, 8th week and 12th week
to evaluate the children with CP according to their motor functional ability - Scores (0% - 100%) where higher grade means better outcome.
Comparison of Feet Maximum Force scores between the three groups from baseline at 4, 8 and 12 weeks
时间窗: baseline, 4th week, 8th week and 12th week
Measuring Feet Maximum Force of the participants - Higher grade means better outcome
Comparison of Cerebral Palsy Quality of Live Questionnaire (Functioning dimension) scores between the three groups from baseline at 4, 8 and 12 weeks
时间窗: baseline, 4th week, 8th week and 12th week
1. Items numbers in the questionnaire: (8,22,23,24,27,29,34,35,37,38,39,40). 2. Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy. 3. To be calculated by summation of all the dimension's score. 4. Higher score means better outcome
次要结局
未报告次要终点
研究者
Ali AlGhamdi
Sr. Physical Therapy Specialist
King Fahad Armed Forces Hospital