Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00011874

Trial Description

start of 1:1-Block title

Title

Gait impairment following stroke:
is it a problem of dorsiflexion and trunk instability or rather a problem of plantar flexion?

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

Plantarflex

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

[---]*

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Gait abnormalities following stroke are often disabling, negatively affecting patients' quality of life. Reduced ankle dorsiflexion, knee flexion, or hip flexion torques are often postulated causes of compromised toe clearing during the swing phase of gait, leading to an increased risk for falls. Conversely, gait asymmetry and reduced walking speed has been attributed to weakness of the plantar flexors. The aim of this trial is to evaluate the effects of a gait training strengthening the plantar flexors, compared to a gait training stabilizing the trunk and strengthening the dorsi- and hip flexors in an in-patient rehabilitation center. Outcome will be defined in terms of gait and kinematic parameters. Patients with a first ever stroke, who are able to walk with an aid will be recruited and randomized to one of two interventions. The experimental group will receive training of the extensor synergy with a focus on strengthening the plantar flexors twice daily over four weeks. The control group receives a dose-matched training strengthening the flexor synergy, inhibiting the extensor synergy and stabilizing the trunk. Primary outcome variable is Dynamic Gait Index, which will be assessed before, at the end and three months past intervention. In addition video gait analysis, gait speed, Functional Ambulation Categories and muscle strength testing will be performed.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00011874
  •   2017/03/23
  •   [---]*
  •   yes
  •   Approved
  •   086-14-10032014, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   I63.3 -  Cerebral infarction due to thrombosis of cerebral arteries
  •   G81.1 -  Spastic hemiplegia
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   The therapy goals oft he experimental group ( Extensor training = ET) are:
    1.to enhance elasticity and eccentric control of the Plantarflexors to gain better stability in Mid-stance (MST) and to achieve optimal lengthening during the end of Mid-stance to enable better push-off.
    2.Better motorneuron recruitment and frequency (intramuscular coordination) of plantarflexors, especially long toe flexors, during Terminal stance (TST) to clear toes from the ground for Initial swing and to enable better elongation of tibiales anterior muscle (intermuscular coordination).
    3.To enhance recruitment and frequency of hamstrings for better stability during Stance (intramuscular coordination) and for better foot clearance during Swing.
    4.Differntial training (randomized exercises) in different environmental conditions to enhance automatization and gain better gait stabilty for reducing falls.
  •   The control group is to receive a so-called standard therapy (STD), entailing the following goals:

    1.Trunk stabilization to achieve better stability for gait.
    2.Stengthening of the hip flexors and foot lifters to achieve better initiation of swing and to reduce the risk of falling.
    3.Inhibition of Plantarflexors to enable better function of Swing phase during gait.
    4.Inhibiton of quadriceps muscle to enable better knee flexion in Pre-swing (PSW) and Initial Swing (ISW).
    5.Aiding foot lift during gait
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   investigator/therapist, assessor, data analyst
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Primary outcome parameter: Dymnamic Gait Index is assesd before, at the end of 4 weeks of intervention and 3 months after inclusion into the study

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

secondary outcome parameters :
1.Gait analysis: using video documentation to assess the following parameters:
-hip extension, knee control, dorsiflexion, vertical trunk alignment during stance, observed from the sagital plane.
-Knee flexion during pre-swing, observed from the sagital plane.
-Stride length and heel lift during Terminal stance, observed from the sagital plane.
-Heel contact during initial contact, observed from the sagital plane.
-Forefoot pronation during Mid-stance and Terminal stance, observed from ventral in the frontal plane.
-Hiking of the hip during Initial swing, observed from dorsal in the frontal plane.
2.Gait speed: 10 Meters.
3.Functional Ambulation Categories (FAS)
4.Muskel function tests (Janda): Dorsi- and Plantarflexors (ankle and toes), knee flexors, -extensors, hip extensors, -flexors, -abductors, -adductors

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2016/01/01
  •   56
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

1. patients having experienced a supra-tentoriel stroke for the first time which occurred at least 4weeks prior,
2.who measure gait speed slower than 0,4 sec./min. and
3. show a higher risk of falling, measured according to the Dynamic Gait Index (DGI) and Functional ambulation Categories .
4. They must demonstrate weakness of the foot muscles, measured by Muscle Function Tests according to Janda of 3-4.
5.During gait they should not be able to reach initial contact (IC) with the heel and initiate swing (ISW) by compensatory hiking of the pelvis.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Patients who hare not able to walk - with or without aids - are to be excluded.
Patient ,who are not able to communicate
Patients, who have a neglect
Patients with additional neurologic diseases (i.e. SAE, Parkinson Sndrome, MS)
Patient with musculosceletal diseases
Patients with cancer
Patients, who participate in other trials

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • NRZ Leipzig-Bennewitz,Universität Leipzig
    • Ms.  PD Dr. med. habil.  Caroline  Renner 
    • Muldentalweg 1
    • 04828  Bennewitz
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • NRZ Leipzig-Bennewitz,Universität Leipzig
    • Ms.  PD Dr. med. habil.  Caroline  Renner 
    • Muldentalweg 1
    • 04828  Bennewitz
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • NRZ Leipzig-Bennewitz,Universität Leipzig
    • Ms.  PD Dr. med. habil.  Caroline  Renner 
    • Muldentalweg 1
    • 04828  Bennewitz
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Universitätsklinikum Leipzig
    • Liebigstr. 18
    • 04103  Leipzig
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.