Trial document





This trial has been registered retrospectively.
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  DRKS00004284

Trial Description

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Title

Effect of en bloc physiotherapy compared to regular physiotherapy

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Trial Acronym

PT-Study

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URL of the Trial

[---]*

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Brief Summary in Lay Language

It is unclear whether physiotherapy on a regular base or en block with breaks is more effective to produce functional progress. For this purpose regular therapy is compared with double frequency of therapy for 1/4 of a scholastic year followed by an equal break period (Group A starting with regular therapy 1st year and block wise therapy 2nd and Group B inverse to group A). The study runs over 2 scholastic years. All patients with cerebral palsy or non progressive brain damage present before the age of two participate. The aim is functional progress. It is hypothesized that en block therapy is more efficient.

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Brief Summary in Scientific Language

Question: Is physiotherapy more efficient when applied blockwise or continuously in children with cerebral palsy? Design: A prospective randomized study with a cross-over design compared the effect of regular physiotherapy with blocks of physiotherapy alternating with no physiotherapy. Each physiotherapy regimen was assessed over one scholastic year. Group A received their regular physiotherapy and group B received blocks of physiotherapy. Each child was treated by the same therapist during the study period. Four observers were blinded to the treatment regimen the children received and classified them with the GMFCS and assessed them with the Gross Motor Function Measure 66 (GMFM66) and two questionnaires. Participants: 39 children aged 6-16 years, (mean = 10.32 years; SD 2.91) and GMFCS levels II-IV. Outcome measures: GMFM 66 and two questionnaires. Results: Twenty six children completed the study and children in both groups improved over the whole study period according to their GMFM 66 assessments: group A by 3.5 points (95% CI 2.69 to 4.31, d = 0.27) and group B by 2.62 points (95% CI 2.03 to 3.21, d = 0.15). Both groups also improved during regular physiotherapy in dimension D (standing) of the GMFM group B by 2.08 points (95% CI 1.63 to 2.53, d = 0.13) and dimension E (walking, running and jumping) group A by 4.77 points (95% CI 3.46 to 6.08, d = 0.2) and group B by 2.23 points (95% CI 1.69 to 2.77, d = 0.08), but there was no significant improvement during blocks of physiotherapy. Conclusion: Regular physiotherapy had the greater potential for a beneficial effect on function. The children who gained most benefit were functional but at a low level as classified by the GMFM dimensions.

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Organizational Data

  •   DRKS00004284
  •   2012/07/30
  •   [---]*
  •   yes
  •   Approved
  •   294/07, Ethikkommission beider Basel EKBB
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Secondary IDs

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

  •   Cerebral palsy
  •   G80 -  Cerebral palsy
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Interventions/Observational Groups

  •   regular physiotherapy 1-2x/week over one scholastic year
  •   physiotherapy en block (double intensity of Physiotherapy /week for 1/4 of the scholastic year alternating with a break of 1/4 of a scholastic year, 2 runs for 1 year)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Single blind
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  •   Active control
  •   Treatment
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

After each year the functional progress is assessed by the Gross Motor Function Measure.

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Secondary Outcome

One qquestionnaire asks about the subjective impression (every year) and another one about changes of therapy / rehabilitation for qualitiy control (at end of study)

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Countries of Recruitment

  •   Switzerland
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2008/08/01
  •   50
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   6   Years
  •   16   Years
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Additional Inclusion Criteria

All children with cerbral palsy and similar diseases (brain damage till age 2years)

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Exclusion Criteria

planned surgery or changes in the rehabilitation programme (botulinum toxin injection, casts, change of physiotherapy)

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Addresses

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    • Universitätskinderspital beider Basel, Neuroorthopädie
    • Mr.  Prof  Reinald  Brunner 
    • Spitalstr. 33
    • 4031  Basel
    • Switzerland
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    • Physiotherapie Anne- Louise Brunner, c/o Physiotherapie Erik Goossens, Binningen
    • Ms.  MAS  Anne-Louise  Brunner 
    • Schmiedengasse 11
    • 4104  Oberwil
    • Switzerland
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    • Universitätskinderspital beider Basel
    • Mr.  Prof  Reinald  Brunner 
    • Spitalstrasse 33
    • 4031  Basel
    • Switzerland
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Sources of Monetary or Material Support

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    • Stiftung Cerebral
    • Erlachstrasse 14
    • 3012  Bern
    • Switzerland
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Status

  •   Recruiting complete, follow-up complete
  •   2010/07/31
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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.