Trial document





This trial has been registered retrospectively.
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  DRKS00013979

Trial Description

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Title

Immediate effects of rest periods on balance control in patients after stroke. A randomized controlled pilot trial.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Background: Stroke Patients often suffer from balance disorders. For this reason, a balance training provides a large percentage of content in physiotherapy. What we know is that a high number of repetitions in motor skill training is one of the promoting factors for motor learning. Whether a break between each exercise blocks, as usual in training therapy, also plays a role in therapy for stroke patients is unknown. The aim of this study is to find out exactly that.
Methods: In a randomized controlled study design 20 patients after stroke will be included in this study. The balance ability will be verified with the single-leg stance and the tandem-stance. By drawing lots, the patients will be randomized into 2 groups. In group A the participants will have a one-minute break between the six two-minute exercise blocks. The participants in group B will have a four-minute break between the six two-minute exercise blocks.

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Brief Summary in Scientific Language

Background: Stroke Patients often suffer from balance disorders. For this reason, a balance training provides a large percentage of content in physiotherapy. What we know is that a high number of repetitions in motor skill training is one of the promoting factors for motor learning. Whether a break between each exercise blocks, as usual in training therapy, also plays a role in therapy for stroke patients is unknown. The aim of this study is to find out exactly that.
Methods: In a randomized controlled study design 20 patients after stroke will be included in this study. The balance ability will be verified with the single-leg stance and the tandem-stance. By drawing lots out of an opaque, sealed and numbered envelope, the patients will be randomized into 2 groups. In group A the participants will have a one-minute break between the six two-minute exercise blocks. The participants in group B will have a four-minute break between the six two-minute exercise blocks.

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Organizational Data

  •   DRKS00013979
  •   2018/02/01
  •   [---]*
  •   yes
  •   Approved
  •   12-2/01/02/01, Gera - SRH Hochschule für Gesundheit - Ethikkomission Physio- und Ergotherapie
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Secondary IDs

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Health Condition or Problem studied

  •   I63 -  Cerebral infarction
  •   I61 -  Intracerebral haemorrhage
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Interventions/Observational Groups

  •   The following exercises were selected and used as intervention in both groups:
    1) Stand with narrow base of support
    2) stand and look behind (Standing and turning in narrow step widths)
    3) Stand in semi-tandem stance
    4) Stand with one leg forward and look behind
    5) Stand in tandem stance
    6) stand on one leg with support
    7) Standing on one leg with the other leg resting on a foam cup.

    According to individual balance difficulties five out these seven tasks were used as an exercise set and every set lasted for two minutes. All patients had to exercise six sets (of the above described balance exercises). Therefore all patients had the same type of exercises in approximately comparable difficulties in the same exercise time. We instructed patients in the SR group to rest for 1 minute after every exercise set.
  •   The following exercises were selected and used as intervention in both groups:
    1) Stand with narrow base of support
    2) stand and look behind (Standing and turning in narrow step widths)
    3) Stand in semi-tandem stance
    4) Stand with one leg forward and look behind
    5) Stand in tandem stance
    6) stand on one leg with support
    7) Standing on one leg with the other leg resting on a foam cup.

    According to individual balance difficulties five out these seven tasks were used as an exercise set and every set lasted for two minutes. All patients had to exercise six sets (of the above described balance exercises). Therefore all patients had the same type of exercises in approximately comparable difficulties in the same exercise time. We instructed patients in the SR group to rest for 4 minutes after every exercise set.
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Characteristics

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

- One-leg standing time in seconds (OLST). We used the OLST on the affected leg with the patients having their eyes open as an index of postural stability, with a maximum time of 60 s allowed.
- Tandem standing time in seconds (TST). We used the TST with the patients having their eyes open to measure static double stance balance. With this test we measured whether and how long the patient can maintain a tandem standing position (one foot in front of the other foot) without holding on, with a maximum time of 60 s allowed.
We measured the OLST and the TST immediately after the last of their six sets of balance exercises and did a retention test of the OLST and the TST 24 hours later.

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Secondary Outcome

None

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2015/07/01
  •   20
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   45   Years
  •   80   Years
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Additional Inclusion Criteria

We will include all patients after first stroke, aged between 45 to 80 years, who are able to walk with physical assistance or supervision of one person (Functional Ambulation Categories, FAC 2 or 3), reduced muscle strength in the affected hip flexors and abductors (defined as Medical Research Council, MRC grade three or four), without apparent limitations in proprioception of the paretic leg (defined as 3 to 6 points in the sensory subtest of the Fugl-Meyer Assessment of the lower limb, FMA) and good to moderate trunk control (defined as more than 48 points in the Trunk Control Test, TCT) and written informed consent.

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Exclusion Criteria

We will exclude patients with neurological diseases such as dementia or brain tumours, with orthopaedic disease causing pain in the lumbar spine and hip area, severe global aphasia and a pronounced neglect (defined as ≤ 100 points in the Behavioural Inattention Test, BIT).

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Addresses

  • start of 1:1-Block address primary-sponsor
    • HELIOS Rehaklinik Damp
    • Mr.  Simon  Schweder 
    • Seute-Deern-Ring 30
    • 24351  Damp
    • Germany
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    • HELIOS Rehaklinik Damp
    • Mr.  Simon  Schweder 
    • Seute-Deern-Ring 30
    • 24351  Damp
    • Germany
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  • start of 1:1-Block address public-contact
    • HELIOS Rehaklinik Damp
    • Mr.  Simon  Schweder 
    • Seute-Deern-Ring 30
    • 24351  Damp
    • Germany
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Sources of Monetary or Material Support

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    • HELIOS Rehaklinik Damp
    • Mr.  Simon  Schweder 
    • Seute-Deern-Ring 30
    • 24351  Damp
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/09/09
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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.