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CompletedNCT01187277BB200810Updated Jul 17, 2012

Robotic Versus Conventional Training on Hemiplegic Gait.

A Phase 3 interventional study of conventional therapy and conventional plus robotic gait assisted therapy in Stroke, sponsored by Prasat Neurological Institute. Completed at 1 site in Thailand. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-07-17.

Sponsored by Prasat Neurological Institute · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study summary

The incidence of stroke in the industrial world is still high. Most of the patients are suffering from paresis of the affected side, speech and cognition problems. Modern concepts of motor learning after stroke favouring a task-specific repetitive high-intensity therapy approach to promote motor outcome. In the last couple of years robot-assisted therapy became an important part of modern rehabilitation after stroke. But so far there is no clear evidence that robot assisted therapy in combination with conventional therapy is more effective than conventional therapy alone to promote motor functions after stroke.

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Conditions studied

  • Stroke

Keywords

  • stroke
  • rehabilitation
  • gait training
  • robot-assisted therapy
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In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 60 is above the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Prasat Neurological Institute is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subacute first-time stroke patients(hemorrhage and ischemic)
  • Age 18-80 years.
  • Impaired Functional Ambulation Category at initial score 0-2
  • Cardiovascular stable
  • Given signed inform consent

Exclusion criteria

Exclusion Criteria:

  • Unstable general medical condition
  • Severe malposition or fixed contracture of joint with an extension deficit of more than 30 degree
  • Any functional impairment prior to stroke
  • Can not adequately cooperate in training

    • Severe communication problems
    • Severe cognitive - perceptual deficits
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Group A

    Group A = conventional therapy means: 50 min individual physiotherapy and 60 min individual occupational therapy per work day (5x per week)for four consecutive weeks

    Behavioral: conventional therapy

  • Active comparator
    Group B

    Group B = conventional therapy plus robot-assisted means: 30 min individual physiotherapy plus 20 min robot-assisted gait training and 60 min individual occupational therapy per work day (5x per week)for four consecutive weeks

    Device: conventional plus robotic gait assisted therapy

Interventions

  • Behavioralconventional therapy

    conventional therapy means: 50 min individual physiotherapy and 60 min individual occupational therapy per work day (5x per week)for four consecutive weeks

  • Deviceconventional plus robotic gait assisted therapy

    individual physiotherapy +individual occupational therapy+ robotic gait assisted therapy

    Also known as: Gait trainer GT1

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What researchers measure

Primary outcomes

  1. Functional Ambulation Categories (FAC, 0-5)

    Description of ambulation level of the individual patient, whether and if, how much support is needed.

    Time frame: 4 weeks

  2. Barthel index (BI, 0-100)

    Assesses independence in activity of daily living

    Time frame: 4 weeks

Secondary outcomes

  1. Berg Balance Scale (BBS, 0-56

    Assesses balance abilities.

    Time frame: 4 weeks

  2. REPAS -Muscle tone (REPAS, 0-52)

    Sum score to assess muscle tone for the major joints of the upper and lower extremities.

    Time frame: 4 weeks

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Study locations

1 site
  • Prasat Neurological Institute
    Bangkok, 10400, Thailand
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References and documents

Publications

  • Schwartz I, Sajin A, Fisher I, Neeb M, Shochina M, Katz-Leurer M, Meiner Z. The effectiveness of locomotor therapy using robotic-assisted gait training in subacute stroke patients: a randomized controlled trial. PM R. 2009 Jun;1(6):516-23. doi: 10.1016/j.pmrj.2009.03.009. PubMed 19627940 ↗
  • Hornby TG, Campbell DD, Kahn JH, Demott T, Moore JL, Roth HR. Enhanced gait-related improvements after therapist- versus robotic-assisted locomotor training in subjects with chronic stroke: a randomized controlled study. Stroke. 2008 Jun;39(6):1786-92. doi: 10.1161/STROKEAHA.107.504779. Epub 2008 May 8. Erratum In: Stroke.2008 Aug;39(8): e143. PubMed 18467648 ↗
  • Hidler J, Nichols D, Pelliccio M, Brady K, Campbell DD, Kahn JH, Hornby TG. Multicenter randomized clinical trial evaluating the effectiveness of the Lokomat in subacute stroke. Neurorehabil Neural Repair. 2009 Jan;23(1):5-13. doi: 10.1177/1545968308326632. PubMed 19109447 ↗
  • Pohl M, Werner C, Holzgraefe M, Kroczek G, Mehrholz J, Wingendorf I, Hoolig G, Koch R, Hesse S. Repetitive locomotor training and physiotherapy improve walking and basic activities of daily living after stroke: a single-blind, randomized multicentre trial (DEutsche GAngtrainerStudie, DEGAS). Clin Rehabil. 2007 Jan;21(1):17-27. doi: 10.1177/0269215506071281. PubMed 17213237 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01187277
Lead sponsor
Prasat Neurological Institute
Collaborators
Mahidol University, Charite University, Berlin, Germany
Responsible party
Ratanapat Chanubol (Dr., Prasat Neurological Institute) — Principal investigator
First posted
Aug 24, 2010
Start date
Jan 2011
Primary completion
May 2012
Completion
Jul 2012
Last update
Jul 17, 2012

Study contacts

Ratanapat Chanubol, M.D.
principal investigator · Rehabilitation department, Prasat Neurological Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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