Trial document





This trial has been registered retrospectively.
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  DRKS00008726

Trial Description

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Title

Performance of the spastic calf when waking on sloped surface

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Trial Acronym


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URL of the Trial

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Brief Summary in Lay Language

Cerebral Palsy (CP) results from a damage to the developing brain. As a result the children develop weakness and muscle contractures. Spastic equinus is one of their most common deficits while their calf muscles are short, weak and stiff. Amongst others, this may be caused by altered muscle structure. However, the relations between muscle structure and ambulatory function are not well understood. For children with CP, as well as for their healthy peers, there exists no direct information about the action of calf muscle fibres during gait. Besides, there is a lack of easily accessible and effective tools during physical therapy of CP children. Walking on downhill or uphill slopes could potentially be used to train and stretch the calf of children with CP. This study therefore deals with the immediate effects of CP on muscle fibre behaviour during gait and especially on slopes. To this end, children with CP and controls (aged: 6-16 years) will participate in a gait analytical study. The analysis will be conducted on level ground as well as on a treadmill. Walking on the treadmill will be done on even surface, uphill and backward downhill. Meanwhile electric muscle activity and length of the muscle fibre will be non-invasively measured. We expect to encounter differences between children with CP and controls. Slope walking should have an Impact on muscle activtiy as well as on muscle fibre lengths in both groups.

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Brief Summary in Scientific Language

One of the muscles that atrophies most in Cerebral Palsy (CP) is the M. Gastrocenmius. Generally, short and stiff muscles and the distorted neuro-muscular control may be primary contributers to reduced function during gait. Information about the behaviour of the muscle fibre bundles (fascicles) were however only derived from healthy adults and children or rely on simulations. This study therefore deals with the contractile behaviour of the M. Gastrocnemius of children with CP and controls during walking. Besides, we seek for potential training stimuli to stretch and train the spastic calf. In principle, eccentric muscle contractions are capable to induce growth of fascicles and could therefore also be beneficial in CP. Thus, knowledge about adaptations of Gastrocenmius' activity and working mechanisms to inclines or declines could promote the development of non-invasive treatment approaches.
In this cross-sectional study, 16 children with CP and 16 controls (aged: 6-16 years) should be included. Measurements will be performed on a single occasion. They will consist of a 3D gait analysis (3DGA), conducted on level ground as well as on a treadmill. Additionally, all participants will be manually physically examined for RoM and strength. The 3DGA will be done with infra-red cameras and passive markers to capture joint kinematics. Besides, muscle activity of the M. Tibialis ant., M. Gastroc. med., M. Soleus will be measured be means of wireless surface electromyography. To capture the path of muscle fascicles a ultrasound transducer will be fixed over the M. Gastrocnemius med. On the treadmill, children should walk on 3 different slopes: 0% (even), +12% (forward-uphill) and -12% (backward-downhill).
Primary Outcomes are: 1) Fascicle length of the M. Gastrocnemius med. (Ultrasound); 2) Fascicle shortening and lengthening velocities (Ultrasound); 3) electrophysiological muscle activity / Co-Contraction (EMG). 4) Joint kinematics at the ankle and knee. Secondary outcomes are: 1) passive RoM at the knee and ankle; 2) isometric plantarflexor force (hand-held dynamometry).
It is expected that muscle fascicles of children with CP will work on shorter length and with less excursion than in controls. Besides, the level of Co-Contraction and interfering Gastrocnemius activity (e.g in swing phase) will be higher in CP. Walking on slopes will modulate muscle activity and muscle fascicle behaviour in both groups, while the extend of eccentric muscle contractions will be generally larger on slopes.

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Organizational Data

  •   DRKS00008726
  •   2015/06/18
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  •   yes
  •   Approved
  •   129/15, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
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Secondary IDs

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Health Condition or Problem studied

  •   G80.1 -  Spastic diplegic cerebral palsy
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Interventions/Observational Groups

  •   Childen with CP:
    This study will be conducted in a cross-sectional design on a single occassion. Walking on the treadmill be done in 3 different conditions:

    A) on level ground (0%)
    B) forward uphill (+12%)
    C) backward downhill (-12%)
  •   Control group healthy controls:
    Measurements as described in arm 1
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Diagnostic
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Primary Outcomes are: 1) Fascicle length of the M. Gastrocnemius med. (Ultrasound); 2) Fascicle shortening and lengthening velocities (Ultrasound); 3) electrophysiological muscle activity / Co-Contraction (EMG). 4) Joint kinematics at the ankle and knee (3D Motion capturing)

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Secondary Outcome

Secondary outcomes are: 1) passive RoM (Range of Motion) at the knee and ankle; 2) isometric plantarflexor force (hand-held dynamometry).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2015/04/10
  •   32
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   6   Years
  •   16   Years
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Additional Inclusion Criteria

Inclusion Criteria for CP children:
1) spastic Cerebral Palsy;
2) age: 6-16 years;
3) Gross Motor Function Classification System I-II (~free ambulators without assistive device);
4) compliance with treadmill walking.


Inclusion Criteria for controls:

1) age: 6-16 years;
2) compliance with treadmill walking.

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Exclusion Criteria

Exclusion criteria for CP:
1) Inability to follow verbal instructions;
2) Botulinum Toxin injections < 6 months;
3) soft-tissue surgery to the lower leg;
4) any orthopaedic surgery < 12 months.

Exclusion criteria for healthy controls:
1) orthopaedic or neurogenic abnormalities;
2) trauma to the lower extremity < 12 months;
3) orthopaedic surgery to the lower extremity.

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Addresses

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    • Behandlungszentrum Aschau GmbH nonprofit Organisation
    • Bernauerstr. 18
    • 83229  Aschau
    • Germany
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    • Professur für Biomechanik im Sport Fakultät für Sport- und GesundheitswissenschaftenTechnische Universität München
    • Georg-Brauchle-Ring 60/62
    • 80992  München
    • Germany
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    • Gait LaboratoryOrthopaedic Hospital for Children Behandlungszentrum Aschau GmbHnonprofit Organisation
    • Mr.  MSc  Matthias  Hösl 
    • Bernauerstr. 18
    • 83229  Aschau i. Chiemgau
    • Germany
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    • Gait LaboratoryOrthopaedic Hospital for Children Behandlungszentrum Aschau GmbH nonprofit Organisation
    • Mr.  MSc  Matthias  Hösl 
    • Bernauerstr. 18
    • 83229  Aschau i. Chiemgau
    • Germany
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Sources of Monetary or Material Support

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    • Behandlungszentrum Aschau GmbH nonprofit Organisation
    • Bernauerstr. 18
    • 83209   Aschau
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/08/31
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Trial Publications, Results and other Documents

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