search
Back to results

Robotic Versus Conventional Training on Hemiplegic Gait. (BB200810)

Primary Purpose

Stroke

Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
conventional therapy
conventional plus robotic gait assisted therapy
Sponsored by
Prasat Neurological Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, rehabilitation, gait training, robot-assisted therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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

Sites / Locations

  • Prasat Neurological Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

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

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

Outcomes

Primary Outcome Measures

Functional Ambulation Categories (FAC, 0-5)
Description of ambulation level of the individual patient, whether and if, how much support is needed.
Barthel index (BI, 0-100)
Assesses independence in activity of daily living

Secondary Outcome Measures

Berg Balance Scale (BBS, 0-56
Assesses balance abilities.
REPAS -Muscle tone (REPAS, 0-52)
Sum score to assess muscle tone for the major joints of the upper and lower extremities.

Full Information

First Posted
August 20, 2010
Last Updated
July 15, 2012
Sponsor
Prasat Neurological Institute
Collaborators
Mahidol University, Charite University, Berlin, Germany
search

1. Study Identification

Unique Protocol Identification Number
NCT01187277
Brief Title
Robotic Versus Conventional Training on Hemiplegic Gait.
Acronym
BB200810
Official Title
A Randomized Controlled Trial on Hemiplegic Gait Rehabilitation: Robotic Locomotor Training Versus Conventional Training in Subacute Stroke.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prasat Neurological Institute
Collaborators
Mahidol University, Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, rehabilitation, gait training, robot-assisted therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
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
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
conventional therapy
Intervention Description
conventional therapy means: 50 min individual physiotherapy and 60 min individual occupational therapy per work day (5x per week)for four consecutive weeks
Intervention Type
Device
Intervention Name(s)
conventional plus robotic gait assisted therapy
Other Intervention Name(s)
Gait trainer GT1
Intervention Description
individual physiotherapy +individual occupational therapy+ robotic gait assisted therapy
Primary Outcome Measure Information:
Title
Functional Ambulation Categories (FAC, 0-5)
Description
Description of ambulation level of the individual patient, whether and if, how much support is needed.
Time Frame
4 weeks
Title
Barthel index (BI, 0-100)
Description
Assesses independence in activity of daily living
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Berg Balance Scale (BBS, 0-56
Description
Assesses balance abilities.
Time Frame
4 weeks
Title
REPAS -Muscle tone (REPAS, 0-52)
Description
Sum score to assess muscle tone for the major joints of the upper and lower extremities.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ratanapat Chanubol, M.D.
Organizational Affiliation
Rehabilitation department, Prasat Neurological Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prasat Neurological Institute
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
19627940
Citation
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.
Results Reference
result
PubMed Identifier
18467648
Citation
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.
Results Reference
result
PubMed Identifier
19109447
Citation
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.
Results Reference
result
PubMed Identifier
17213237
Citation
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.
Results Reference
result

Learn more about this trial

Robotic Versus Conventional Training on Hemiplegic Gait.

We'll reach out to this number within 24 hrs