Trial document





This trial has been registered retrospectively.
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  DRKS00015083

Trial Description

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Title

Is there a dose-response relationship of robotic-assisted therapy in motor rehabilitation of the upper extremity after stroke? A Pilot Study with the Armeo®Spring.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

For optimal therapy for stroke patients, it must be known how often training is required to achieve the greatest possible motor improvement. The aim of this study is therefore to measure and analyze the motor improvements through a selected training program with the Armeo®Spring. The Armeo®Spring is a spring-based exoskeleton for helping to regain arm and hand function. The spring technology makes it possible to manipulate the influence of gravity to tailor the device to the muscular strength of the patient. In addition, the device can detect via built-in sensors the maximum range of motion and adjust training difficulties accordingly. Training with the device takes place on a computer via games selected by the therapist.
In this study, patients are included after a first stroke that occurred no more than three months ago (subacute phase).
Stroke patients are assigned to one of 2 groups according to age and motor impairment. In group 1, a three-week training program will be carried out in addition to the usual therapies offered in the rehabilitation facility. Group 1 receives five additional training sessions per week with the exoskeleton, for a total of 15 units. The duration of such a unit is 45 minutes. Group 2 receives the usual 2 sessions per week, 30 minutes each.
Before starting the training, some tests will be done on both cognitive and motor skills. Upon successful completion of the training program, motor tests are performed a second time to visualize possible improvements. Another two weeks after the completion of the program, another investigation will be carried out with a third survey of motor tests (follow-up examination).
Once before and once after the training program, various imaging examinations in the MRI will take place in order to be able to make statements about possible adaptations of the motor network of the brain. An investigation with a transcranial magnetic stimulation should also determine the conductivity of the nerve tracts that lead from the brain to the extremities. This examination also takes place once before and once after the training program.

The study will be submitted for publication under the title: “Behavioral and Neurophysiological Effects of an Intensified Robotic-Assisted Therapy in Subacute Stroke”. Justification: The new title presents the results of the study more precisely. The significance of the electrophysiological results, which was not yet recognizable when the study was registered, is therefore easier to recognize.

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Brief Summary in Scientific Language

The use of (electro) mechanical devices to support motor rehabilitation is not only gaining in popularity but can be considered effective in terms of activities of daily living as well as arm and hand function. However, currently there are no clear statements regarding training intensity and volume of training.
This study investigates the impact of increased therapy on the degree of functional recovery of the paretic upper limb in stroke patients in the subacute phase. It is hypothesized that a significant increase in therapy units is needed to achieve a significantly greater improvement in motor function compared to conventional rehabilitation treatment.
In this pilot study a magnetic resonance tomography/functional magnetic resonance tomography measure (MRI/fMRI) is also planned to record the adaptation of the cerebral motor network in parallel to the expected clinical improvement and to determine the neuronal correlates of the functional improvement. With transcranial magnetic stimulation (TMS) the motor evoked potentials should be measured. This makes it possible to visualize changes in the neuronal recruitment of the proximal musculature, as well as correlations between the integrity of the corticospinal tracts and clinical improvement.
This study is a simple blinded case control study in patients with hemiparesis after first stroke (subacute phase <3 months). A total of 30 patients are included in this study (Intervention and control group 15 patients each). Patients in the control group receive conventional rehabilitative therapy including a low-dose Armeo®Spring treatment (2 times / week). The intervention group will receive a 45 minute training session with the Armeo®Spring 5 times a week for three weeks additionally to the conventional rehabilitative therapy.
Study procedure:
a. Baseline measurements: Fugl-Meyer Assessment in upper limb (FMA); Montreal Cognitive Assessment (MoCA); Apraxia measurement; Bells test; TMS (Single stimuli, cortical silent period (cSP) at stimulation intensity 120% above the individual stimulus threshold); MRI/fMRI (resting state fMRI, structural MRI, diffusion tensor imaging)
b. Post-test after three weeks (FMA, TMS, MRI/fMRI)
c. Follow-up after another two weeks (FMA).

The study will be submitted for publication under the title: “Behavioral and Neurophysiological Effects of an Intensified Robotic-Assisted Therapy in Subacute Stroke”. Justification: The new title presents the results of the study more precisely. The significance of the electrophysiological results, which was not yet recognizable when the study was registered, is therefore easier to recognize.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00015083
  •   2018/09/04
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  •   yes
  •   Approved
  •   32/2016, Ethik-Kommission der Universität Konstanz
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Secondary IDs

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Health Condition or Problem studied

  •   I60 -  Subarachnoid haemorrhage
  •   I61 -  Intracerebral haemorrhage
  •   I62 -  Other nontraumatic intracranial haemorrhage
  •   I63 -  Cerebral infarction
  •   I64 -  Stroke, not specified as haemorrhage or infarction
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Interventions/Observational Groups

  •   In addition to conventional rehabilitative therapy, the intervention group receives a 45-minute training session with the Armeo®Spring 5 times a week for three weeks.
  •   Patients in the control group receive conventional rehabilitative therapy including a low-dose Armeo®Spring treatment (2 times / week for 30 minutes each).
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Blinded
  •   assessor
  •   Active control (effective treament of control group)
  •   Treatment
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Fugl-Meyer Assessment in upper limb (at baseline; Post-test after three weeks; Follow-up after another two weeks).

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Secondary Outcome

Transcranial magnetic stimulation (single stimuli, cortical silent period (cSP) at stimulation intensity 120% above the individual threshold at baseline and after 3 weeks); Magnetic Resonance Imaging / Functional Magnetic Resonance Imaging (resting state fMRI, structural MRI, diffusion tensor imaging at baseline and after 3 weeks).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2017/04/27
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1. Ability to give informed consent for the participation in the study
2. Sufficient understanding of instructions
3. Ability to operate the Armeo®Spring
4. first cerebrovascular incident leading to hemiplegia, subacute phase < 3 months following incident
5. Movement of the arm possible if the weight of the arm is carried by a support (at least strength level 2 for shoulderjoint movement)
6. At least 18 years of age

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Exclusion Criteria

1. prior history of neurological or psychiatric conditions
2. cognitive impairements that hinder the understanding of the study (e.g. receptive (Wernicke) aphasia, global aphasia, dementia)
3. participants demonstrating insufficient compliance
4. severe apraxia
5. severe neglect-relevant pain symptoms of the affected side of the body (>3 on the visual analoge scale [scale ranging from 0 to 10]
6. epilepsy or previous history of epileptic episodes
7. pregnancy
8. Presence of a [cardiac] pacemaker, implanted medical, electromedical or other devices
9. Presence of metallic and conductive inclusions or implants
10. Participants have tattoos in the head- or neckregions, nicotin patches or cosmetic manipulations of the eyelids (permanent make-up)
11. Participants suffering from claustrophobia
12. Participants with metalic contraceptives such as a contraceptive coil (possibly comprised of copper)

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Addresses

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    • Lurija Institut Kliniken Schmieder Allensbach
    • Zum Tafelholz 8
    • 78476  Allensbach
    • Germany
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    • Kliniken Schmieder Allensbach
    • Mr.  Prof. Dr.  Joachim  Liepert 
    • Zum Tafelholz 8
    • 78476  Allensbach
    • Germany
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    • Lurija Institut Kliniken Schmieder Allensbach
    • Ms.  Dr.  Aida  Sehle 
    • Zum Tafelholz 8
    • 78476  Allensbach
    • Germany
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Sources of Monetary or Material Support

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    • Lurija Institut Kliniken Schmieder Allensbach
    • Zum Tafelholz 8
    • 78476  Allensbach
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2019/04/09
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Trial Publications, Results and other Documents

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