Trial document




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  DRKS00020825

Trial Description

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Title

The effect of coordinative training on balance and walking ability in ataxic people with acute cerebral stroke

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Trial Acronym

GLAAS II

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URL of the Trial

http://none

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Brief Summary in Lay Language

Background, Hypothesis and Outcomes
Strokes occur with an incidence of 25.000 per year in Austria. Fourteen percent of them suffer from ataxia, which means the patient loses full control of their bodily movements. Patients with ataxia suffer from disturbance of balance and coordination. This leads to exceedingly uncontrolled, swaying movements and increase the risk of falls.
There are hardly any targeted treatment methods for ataxia after stroke and they fail to show significant improvement compared with conventional physical therapy. Coordinative training is found to be superior treating symptoms in other types of ataxia. It aims to help improve balance (both when still and moving) and coordination skills and to reduce fear (of falling) and stiffness.
Therefore, the hypothesis H1 was defined as following: Coordinative training is more effective at improving balance (measured using the Berg Balance Scale - BBS) in people with ataxia after acute stroke than conventional physiotherapy. The aim of this study is to find out whether the Coordinative Training is more effective at improving balance and coordination in people with acute stroke than standard physiotherapy. A pilot study was conducted in 2016 at the University Hospital Innsbruck (ISRCTN 14527641) which showed no adverse events (side effects) of the new therapy method.

Who can participate?
Adults who have had a stroke and are suffering from, ataxia and balance problems.
Participant inclusion criteria:
1. Acute cerebral stroke
2. Male and female participants aged 18 years and over
3. Ataxia of gait and/or stance and/or sitting and/or positive heel-shin slide (assessed with "Scale for the Assessment and Rating of Ataxia - SARA"): score of at least 1 point in SARA
4. Berg Balance Scale (BBS) ≤ 47 points
5. Written informed consent

Participant exclusion criteria:
1. Cerebral stroke in case history with persistent motor deficits (mRS ≥ 3)
2. Comorbidity, which would restrain the participation (e.g. life expectancy less than 3 month, alcohol or drug abuse)
3. Modified Rankin Scale (mRS) ≥ 5
4. Any physical or mental condition the investigator believes would not allow safe participation in the study or would complicate assessment of outcomes (e.g. dementia, cardiac insufficiency, severe Aphasia, people having a procurator appointed, etc.)
5. Pregnancy
6. People fulfilling military service

What will be done?
Participants are randomly allocated to one of two groups. Those in the first group receive 20 times 45-minute sessions of standard physiotherapy over the course of 4 weeks (5 units per week). This involves taking part in active exercises including balance training, gait (walking) training, core stability and training in everyday activities (activities of daily living). Those in the second group receive the same amount of physical therapy but are manly conducting coordinative exercises (similar to the Doris-Broetz-Concept). This involves a range of exercises, which are completed with a physical therapist while trying to stop the body from becoming stiff by swaying. Approximately after 2 weeks the Participants leave the Acute Care to a Rehabilitation Center (Reha Zentrum Münster/ Ö. Landeskrankenhaus Hochzirl-Natters) which is routine procedure. During the 4 weeks of intervention and for 8 weeks afterwards home exercises are given to the patients (15 minutes per day/ 5 days per week). Participants in both groups complete a number of assessments at the start of the study and then again after the physical therapy (1 month) and after the home exercise program (3 months later), in order to find out if there are changes in balance, coordination, fear and/or risk of falling.

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Brief Summary in Scientific Language

Justification, Relevance
Strokes occur with an incidence of 25,000 people (per year) in Austria, 2000 in the State of Tyrol (Willeit 2014). According to the NIH Stroke Scale, 14% of this patient group are suffering from ataxia*. However, studies on the rehabilitation of ataxic patients are rare (Kruger et al. 2007; Marquer A. 2014), especially after stroke (Blutmann et al. 2014). Most of the studies on rehabilitation of ataxic symptoms are conducted in patients with Friedreich's ataxia, multiple sclerosis or degenerative cerebellar ataxia and mostly investigate coordinative training (Pérez-Avila et al., 2004; Ilg et al., 2009; Ilg et al., 2010; Ilg et al., 2012; Miyai et al., 2012; Synofzik et al., 2013; Sartor-Glittenberg and Brickner, 2014), which is particularly effective in practical application (Marquer et al., 2014; Ilg et al., 2010; Brötz et al., 2007). In order to investigate the feasibility of the coordinative training in the rehabilitation of stroke patients, a pilot study was carried out at the University Hospital of Innsbruck in 2016 (ISRCTN 14527641). The study protocol was feasible and exposed no safety concerns. Furthermore, coordinative training showed a favorable effect on balance, measured using the Berg Balance Scale (BBS), which indicated the need of a larger clinical trial to test effectiveness with an appropriate number of participants.
* Evaluation from the Stroke Card Project - University Hospital of Innsbruck. Out of 683 included patients with stroke at time T0 (= day of admission).

Design
To investigate the effects of conventional physiotherapy and coordinative training on balance ability (as measured by BBS) in ataxic stroke patients, a randomized, controlled, single-blind trial will be conducted. There will be a block randomization using the strata age and gender. The rater who undertakes the initial testing, post-intervention and follow-up testing of the participants, is blinded.

Recruitment
All patients who are admitted to the University Hospital of Innsbruck starting with May 18, 2020 (planned) due to a stroke will be checked for their eligibility. If this is the case, the investigator in charge will seek an informative briefing with the patient. A total of 94 patients (40 per group, taking a drop-out rate of 15% into account) should be included by March 31, 2023.

Procedure
If consent is given to participate in this study, the baseline examination will be carried out. The patient is assigned to one of two groups based on the randomization list. One group is receiving coordinative training and the other one conventional physiotherapy. Both groups receive 20 therapy units, 45 minutes each, over a period of 4 weeks (5 units per week). During this time, the participant will be transferred from the acute to the rehabilitation hospital (Reha Zentrum Münster / Ö. Landeskrankenhaus Hochzirl-Natters) due to the regular treatment procedure. After 4 weeks of supervised therapy post-intervention testing and after 12 weeks a follow-up examination is conducted. Over the entire period (12 weeks), patients in both groups practice 5 times per week independently (15 minutes per unit), with the exercises being put together by the treating therapist.

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

No

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Description IPD sharing plan:

[---]*

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Organizational Data

  •   DRKS00020825
  •   2020/07/16
  •   [---]*
  •   yes
  •   Approved
  •   1050/2020, Ethikkommission der Medizinischen Universität Innsbruck
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Secondary IDs

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

  •   I69 -  Sequelae of cerebrovascular disease
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Interventions/Observational Groups

  •   coordinative training
  •   Standard physical therapy
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   investigator/therapist, assessor, data analyst
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Changes in Balance - measured using the Berg Balance Scale (BBS) at baseline (day 1) and post-Intervention (after 4 weeks)

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Secondary Outcome

1. Changes in walking ability - measured using the TuG, FAC, SARA Scores
2. Changes relating to balance ability - measured using FRT, FGA, Number of falls, posturography (Tymo)
3. Independence in activities of daily living is measured using the Scores of Independence for Neurologic and Geriatric Rehabilitation (SINGER)
4. Quality of life is measured using the EQ 5D 3L

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Countries of Recruitment

  •   Austria
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2020/07/20
  •   94
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

1) First acute cerebral stroke
2) Aged 18 years and over
3) Ataxia of gait and/or stance and/or sitting and/or positive heel-shin slide (assessed with "Scale for the Assessment and Rating of Ataxia - SARA"): score of at least 1 point in SARA
4) Berg Balance Scale (BBS) ≤ 47 points
5) Written informed consent

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Exclusion Criteria

1) Cerebral stroke in case history with persistant neurologic deficits (mRS ≥ 3)
2) Comorbidity which would restrain the participation (e.g. life expectancy less than 3 month, alcohol or drug abuse)
3) Modified Rankin Scale (mRS) ≥ 5
4) Any physical or mental condition the investigator believes would not allow safe participation in the study or would complicate assessment of outcomes (e.g. dementia, cardiac insufficiency, severe Aphasia, people having a procurator appointed, etc.)
5) Pregnancy
6) People fulfilling military service

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Addresses

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    • Medizinische Universität Innsbruck, Universitätsklinik für Neurologie
    • Anichstraße 35
    • 6020  Innsbruck
    • Austria
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • VASCage G.m.b.H.
    • Ms.  MSc  Patricia  Brugnara 
    • Innrain 66a
    • 6020  Innsbruck
    • Austria
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    • VASCage G.m.b.H.
    • Ms.  MSc  Patricia  Brugnara 
    • Innrain 66a
    • 6020  Innsbruck
    • Austria
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Sources of Monetary or Material Support

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    • Medizinische Universität Innsbruck, Universitätsklinik für Neurologie
    • Anichstraße 35
    • 6020  Innsbruck
    • Austria
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • VASCage GmbH
    • Innrain 66a
    • 6020  Innsbruck
    • Austria
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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.