Trial document





This trial has been registered retrospectively.
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  DRKS00006821

Trial Description

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Title

Influence of HAL-training on sensory and motor function in patients with paresis of lower extremity after stroke

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Trial Acronym

HALSTROKE

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In a recent study on patients with spinal cord injury, we could demonstrate an improvement of muscle strength and gait abilities after training with a robot suit.
In our planed study, we want to assess robot suit training on patients with paresis of the leg after stroke. There should be an interval of at least 6 months between stroke and study start to rule out any spontaneous recovery of muscle strength.
We want to include 40 patients divided into two groups. We decided to choose a so called "cross-over" design. One group will start with 6 weeks of robot training, followed by 6 weeks of standard physiotherapy. The other group will start with 6 weeks of standard physiotherapy, followed by 6 weeks of robot suit training.
At the beginning, at cross over after 6 weeks and at the end of the study after 12 weeks, several assessments will be done including questionnaires concerning motor abilities, nerve conduction measurements and gait analysis.

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Brief Summary in Scientific Language

Preliminary results of our recent study with the new exoskeleton HAL® (Hybrid assistive limb) could demonstrate significant improvement of motor function and gait performance in impaired patients with incomplete spinal cord injury after exoskeleton gait training.
In our planed study, we want to assess HAL gait training with chronic stroke patients that have a incomplete paresis of the leg. The time since ictus has to be more that 6 months to exclude effects of spontaneous restitution. We want to include 40 stroke patients decided into two groups. The study deign is a crossover design. The two sequences are "HAL gait training" and "conventional physiotherapy". One group will start with 6 weeks of HAL training, followed by 6 weeks of physiotherapy. The other group will start with 6 weeks of physiotherapy, followed by 6 weeks of HAL training.
At the beginning, at cross over after 6 weeks and at the end of the study after 12 weeks, several assessments will be done including questionnaires concerning motor abilities, nerve conduction measurements and gait analysis.

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Organizational Data

  •   DRKS00006821
  •   2014/11/03
  •   [---]*
  •   yes
  •   Approved
  •   4894-14, Ethik-Kommission der Medizinischen Fakultät der Ruhr-Universität Bochum
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Stroke
  •   I63.9 -  Cerebral infarction, unspecified
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Interventions/Observational Groups

  •   Bodyweight supported treadmill training with HAL (Hybrid Assistive Limb) exoskeleton for 30 minutes on 5 days a week over 6 weeks
  •   Conventional physiotherapy on neurophysiological basis (Bobath's concept) for 30 to 45 minutes on 3 to 5 days a week over 6 weeks (minimal 18 units, maximal 30 units)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Treatment
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

Outcome:
- Gait parameters:
Time points: start of therapy, at crossover, at the end of therapy
Assessments: Time in 10-meter-walking-test, velocity during 10-meter-walking-test, steps during 10-meter-walking-test, distance (m) in 6-minute-walking-test, time for timed-up-and-go-test

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Secondary Outcome

Spasticity:
- Time points: daily, prior and after therapy, upper and lower extremities
- Assesment: modified Ashworth-Scale

Body function and impairment:
- Time points: start of therapy, crossover, end of therapy
- Assesment: total score of NIHS-Scale

Activity of daily life:
- Time points: start of therapy, crossover, end of therapy
- Assesment: total score of Barthel-Index and Functional Independence Measure

Activities and mobility:
- Time points: start of therapy, crossover, end of therapy
- Assesment: total score of Rivermead Mobility Index

Motor function:
- Time points: start of therapy, crossover, end of therapy
- Assesment: total Score of Fugl-Meyer Assessment für untere Extremitäten and Berg Balance Score

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/07/07
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
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Additional Inclusion Criteria

Age within 18 - 75 years,
incomplete paresis of the leg after single incident of stroke, at least 6 months prior

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Exclusion Criteria

1) severely impaired communication due to native language or aphasia, 2) impaired cardiorespiratory capacity, 3) neglect, 4) history of severe infection or history of infection with multiresistent bacteria (e. g. MRSA, ESBL-bacteria), 5) complete paralysis of the leg, 6) history of more than 1 stroke, 7) reduced coagulation (e. g. medication with warfarin), 8) decubital ulcer of the lower extremities and the sacral region, 9) osteoporosis, 10) history of deep vein thrombosis and pulmonary embolism, 11) contracture of the leg, 12) body weight > 100 kg, 13) epilepsy, 14) electric medial devices like cardiac pacemaker, 15) metal implants like ventricular shunt

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Addresses

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    • Neurologische Klinik und Poliklinik
    • Mr.  Prof. Dr.  Martin  Tegenthoff 
    • Bürkle-de-la-Camp-Platz 1
    • 44789  Bochum
    • Germany
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    • Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH, Chirurgische Klinik
    • Mr.  Prof. Dr.  Thomas A.  Schildhauer 
    • Bürkle-de-la-Camp-Platz 1
    • 44789  Bochum
    • Germany
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    • Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH, Neurologische Klinik
    • Mr.  Dr.  Matthias  Sczesny-Kaiser 
    • Bürkle-de-la-Camp-Platz 1
    • 44789  Bochum
    • Germany
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    • Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH, Neurologische Klinik
    • Mr.  Dr.  Matthias  Sczesny-Kaiser 
    • Bürkle-de-la-Camp-Platz 1
    • 44789  Bochum
    • Germany
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Sources of Monetary or Material Support

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    • New Energy and Industrial Technology Development Organization (NEDO)
    • 1310 Omiyacho Saiwai Ward, Kawasaki
    • 212-0014  Kanagawa
    • Japan
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    • Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH
    • Bürkle-de-la-Camp-Platz 1
    • 44789  Bochum
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.