Efficacy of Adding Photo Biostimulation to Standard Physical Therapy Treatment for Spastic Calf Muscle on Tone, Gross Motor Function, Planter Surface Area, and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Modified Ashworth scale for muscle tone assessment
研究概览
简要总结
the current study will address the spasticity in calf muscle secondary to cerebral palsy in children. As the spasticity can inversely affect muscle contraction, joint function, and consequently the function and quality of life, the current study will investigate the effect of adding photobiostimulation therapy to standard physiotherapy on muscle tone, ankle range of motion, gross motor function, plantar surface of the affected foot, and quality of life in patients with spastic cerebral palsy
详细描述
spasticity is one of the common complications associated with upper motor neuron injuries such as cerebral palsy. it can affect the normal developmental process of the child as it restricts muscle performance, limit range of motion, decrease function, and affect the ability to engage in daily activities.
the current study will include 2 groups of children having spastic cerebral palsy. these groups will be randomly distributed to the experimental group (receive standard physiotherapy treatment plus photo biostimulation therapy on related acupuncture points) and the control group will receive a standard physiotherapy program.
the duration of the intervention will be 1 month, 3 sessions per week. the outcome measures will be assessed at baseline, at the end of the intervention ( after 4 weeks of treatment), and at 3 months follow-up.
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)
盲法说明
Concealed allocation will be performed by a researcher who will not be involved in the treatment or assessment. Permuted blocks will be used to assure an equal 1:1 allocation ratio. Due to the nature of the study, the assessor and the patients will be blindfolded (double-blinded). During the first treatment session, the therapist will be allowed to uncover the allocation code to be able to conduct the appropriate treatment.
入排标准
- 年龄范围
- 8 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 8 and 14 years,
- •who had a diagnosis of spastic cerebral palsy by a pediatrician, with at least one spastic - muscle in the extremities,
- •grades 1 -4 on Gross Motor Function Classification System
- •score 1 on the Modified Ashworth Scale (MAS)
- •the ability to walk alone or with assistance
- •whose parents/guardians sign the informed consent form,
- •who were willing to complete the study.
排除标准
- •patients with anatomical disorders,
- •patients who received a botulinum toxin injection in the calf muscle during the last six months
- •surgery in the lower extremity during the previous year
- •severe associated neurological diseases such as epilepsy
- •poor nutritional status,
结局指标
主要结局
Modified Ashworth scale for muscle tone assessment
时间窗: at 4 weeks after the end of the treatment (follow-up)
this scale is a simple clinical scale used to assess muscle tone ans spasticity level. it ranges from 1 to 4 where the lowest value indicate normal muscle tone and the largest value indicate high miscle tone
plantar surface area
时间窗: at 4 weeks after the end of the treatment (follow-up)
A footscan plantar pressure detection system will be used to determine the plantar support area and plantar pressure. This device consists of a force plate (FAS system 1.0 ACP Light, Buratto Advanced Technology, Treviso, Italy), with an active surface (47.5 × 43.0 cm) equipped with 2544 optical sensors distributed along the perimetrical border. it can assess the plantar surface area and the peak pressure in each part of the plantar surface
Gross Motor Function Measure (GMFM) (88 items)
时间窗: at 4 weeks after the end of treatment (follow-up)
Gross Motor Function Measure (GMFM) (88 items) is a tool used to assess changes in gross motor function in cerebral palsy patients. this clinical scale is easy to use and categorize children according to their abilities. where the lower scale mean better gross motor function and higher value means more limitations in gross motor scale
The pediatric quality of life questionnaire for cerebral palsy
时间窗: at 4 weeks after the end of treatment (follow-up)
it is a validated tools with strong psychometric properties and clinical utility. The parent proxy's form (parents of children aged 4-12 years) comprises 66 items and the child self-report form (9-12 years) comprises 52 items. Both the child's and the parent proxy's forms have demonstrated good psychometric properties including internal consistency, test-retest reliability, and construct validity. The higher the score, the better the quality of life is represented
次要结局
未报告次要终点
研究者
Hisham Mohamed Hussein
principal investigator
University of Hail