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临床试验/NCT05269745
NCT05269745已完成不适用

Influence of Immobilisation, Stretching and Activity on Morphological and Mechanical Properties of Spastic Muscle

Medical University of Graz2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2022年6月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
14
试验地点
2
主要终点
Change in mechano-morphological muscle-tendon properties - elongation

研究概览

简要总结

Neurologic changes caused by cerebral palsy (CP) result in adaptation of muscle architecture and function (e.g. shortened muscles and contractures). Stretching through immobilization (orthotic treatment) is one of the common interventions to bring the spastic muscle to growth. Positive outcomes of stretching through immobilization are increased range of motion and improved function. On the other hand, immobilization leads to disuse muscle atrophy. Hence, we hypothesize that combining a stretching through immobilization and muscle activity while controlling for foot deformity could be a superior treatment approach, which should lead to improved muscle morphology as well as function. The aim of the study is to examine the influence of two orthotic treatments (a standard regime and one new approach) on spastic plantar flexor muscles in children and adolescents with CP. The standard regime (stretching through immobilisation) includes a dynamic AFO (ankle-foot orthosis) used during day and night. The new approach combines stretching through immobilisation and allows for plantarflexor activity due to an innovative construction of the orthotic device.

This prospective randomized controlled study will recruit 20 ambulant children and adolescents (aged 5 to 15 years) with cerebral palsy and equinus deformity (GMFCS = Gross Motor Function Classification System level I to III). Each child will be randomized and stratified according to age and GMFCS to one of two groups. The first group receives the standard treatment (stretching through immobilization) using custom-made ankle foot orthosis for 23 hours per day. The other group will be treated with the same orthosis at night (8 hours) and for 6 hours during the day but the remaining 10 hours will be treated with the foot shell only that corrects subtalar and Chopart joints but does not block the ankle joint movement, so that more activity of plantarflexors will be possible during the day. The intervention will last for 12 weeks. Each child will be examined at four occasions (8 weeks before intervention = control phase, at the beginning of the intervention and then 8 and 12 weeks later). The main outcome measure is the fascicle length measured using a 3D ultrasound (3DUS) imaging technique. Further parameters of interest span across the whole levels of ICF including clinical examinations, biomechanics of gait, muscle morphologic and mechanic properties and participations questionnaires.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
5 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Ambulatory children with spastic CP.
  • Ability to accept and follow verbal instruction.
  • Limited range of motion in ankle joint - maximal dorsiflexion with knee extended ≤ 5°
  • Gross Motor Functional Classification System level I-III.
  • Age 5-15 years.
  • Willingness to participate.

排除标准

  • Other than spastic form of CP (ataxic, athetoid or dystonic).
  • Severe mental retardation.
  • Normal range of motion in ankle joint
  • Oral antispastic or muscle relaxing medication.
  • History of orthopaedic surgery in the last 12 months.
  • History of botulinum toxin type A application in the last six months.

研究组 & 干预措施

Immobilization group (IG)

Active Comparator

One group - immobilization group (IG) - will receive the standard treatment.

干预措施: Stretching through immobilisation (IG) (Other)

Immobilization/Activity Group (IAG)

Experimental

The other group - Immobilization/Activity Group (IAG) - will be treated with a new approach.

干预措施: Stretching through immobilisation and activity (IAG) (Other)

Control Phase

Other

Before the intervention with the orthotic treatment starts, a control phase of 8 weeks is planned.

干预措施: Control Phase (Other)

结局指标

主要结局

Change in mechano-morphological muscle-tendon properties - elongation

时间窗: Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)

Passive gastrocnemius medialis muscle belly, tendon and muscle-tendon unit elongation due to externally applied torque to the ankle joint \[elongation in mm\]

Change in mechano-morphological muscle-tendon properties - unit length

时间窗: Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)

Gastrocnemius medialis muscle belly, tendon and muscle-tendon unit length

Change in mechano-morphological muscle-tendon properties - fascile length

时间窗: Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)

Gastrocnemius medialis fascile length

Change in joint range of motion

时间窗: Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)

Ankle joint range of motion (maximal plantarflexion - maximal dorsiflexion)

Change in gait characteristics

时间窗: Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)

Gait kinematics (joint angles \[°\]) and kinetics (joint moments \[Nm/kg\]) of the hip, knee, and ankle joints (3D motion capture). Joint angles \[°\] and moments \[Nm/kg\] will be combined to report changes in gait pattern.

Change in mechano-morphological muscle-tendon properties - muscle volume

时间窗: Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)

Gastrocnemius medialis muscle volume

Change in mechano-morphological muscle-tendon properties - stiffness

时间窗: Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)

Passive gastrocnemius medialis muscle belly, tendon and muscle-tendon unit stiffness due to externally applied torque to the ankle joint \[stiffness in N/mm\]

Change in maximal isometric muscle strength

时间窗: Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)

Maximal isometric torque production (isokinetic dynamometry)

次要结局

  • Change in self-reported gait, mobility, and functional performance - PODCI(Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks))
  • Change in self-reported gait, mobility, and functional performance - GOAL(Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks))

研究者

发起方
Medical University of Graz
申办方类型
Other
责任方
Sponsor

研究点 (2)

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