The Influences of Watching a Movie Clip of Normal Walking on Measurable Walking Parameters Among Post-Brain-Stroke Patients as Opposed to the Influences of a Control Movie Clip Showing Backwards Walking
Primary Purpose
Stroke
Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
watching a normal walking clip
watching walk backward clip
Sponsored by

About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- People after a first ischemic or hemorrhagic stroke, up to 60 days following the event.
- A FAC (Functional Ambulation Category) score test result of 2 or 3, in order to ensure basic mobility, even if still requiring supervision.
- A NIHSS (National Institutes of Health Stroke Scale) score of 3 to 18.
Patients suffering from the following will not be part of the study:
- Significant neglect (a BIT score under 129 in the conventional tests).
- Hemianopsy as determined upon a clinical examination by a rehabilitation physician.
- Clarity of vision problem, determined upon an SC based examination.
- Significant cognitive decline (a Mini mental test score of under 24).
- Aphasia which prevents understanding the signing a Helsinki form.
Exclusion Criteria:
- Patients participating in concurrent researches will not participate
Sites / Locations
- Hadassah University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
study group
CONTROL
Arm Description
People after a first ischemic or hemorrhagic stroke, up to 60 days following the event.
People after a first ischemic or hemorrhagic stroke, up to 60 days following the event.
Outcomes
Primary Outcome Measures
Smart step examination- Average weight on the hind foot and fore foot. Cycle - time (in seconds) from one initial contact to the other (on the same foot). Stance and swing average percentage of one walking cycle, Cadence
Secondary Outcome Measures
2. Two min. walking test. 3. Ten meter walking test. 4. An ABC questioner to determine the personal confidence in regards to walking.
Full Information
NCT ID
NCT00983450
First Posted
September 6, 2009
Last Updated
June 2, 2010
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT00983450
Brief Title
The Influences of Watching a Movie Clip of Normal Walking on Measurable Walking Parameters Among Post-Brain-Stroke Patients as Opposed to the Influences of a Control Movie Clip Showing Backwards Walking
Official Title
The Influences of Watching a Movie Clip of Normal Walking on Measurable Walking Parameters Among Post-brain-stroke Patients as Opposed to the Influences of a Control Movie Clip Showing Backwards Walking
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study will include 20 subjects who will be randomly divided to two groups: a ten person group being the study group and a ten person group acting as a control group (each group will include a similar number of females and males as the other group). In addition, the physiotherapy treatments at the rehabilitation center, the study group will gain an intervention consisting of 12 therapy sessions, administered for 12 consecutive days (apart of weekends). The intervention will include 6 minutes of watching a movie clip alternately showing a healthy man and a healthy woman at their sixties, walking while being filmed from various angles. Immediately after watching, the subject will perform 6 minutes of walking, under the experimenters supervision, but without his or hers intervention. Immediately following the walking, the whole procedure will be repeated (watching a clip and walking).
The control group will undergo 12 treatments of the same nature, but will watch the movie clip shown backwards, so that the people filmed will seem to walk backwards (it was established that watching a reversed action does not activate the MNS system activated by a regular execution of the activity [Celnik et al., 2008]), followed by 6 minutes of walking under the experimenters supervision, then watching the movie again and walking again.
The person performing the examinations will be blinded as to the division of the subjects to the study group and the control group. After performing the previously noted examinations needed to participate in the research, the subjects found fit will be examined before the beginning of the intervention, at its end and then three months after its conclusion. The examinations will include smart step and walking parameters.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Arm Description
People after a first ischemic or hemorrhagic stroke, up to 60 days following the event.
Arm Title
CONTROL
Arm Type
Experimental
Arm Description
People after a first ischemic or hemorrhagic stroke, up to 60 days following the event.
Intervention Type
Other
Intervention Name(s)
watching a normal walking clip
Intervention Description
the study group will gain an intervention consisting of 12 therapy sessions, administered for 12 consecutive days (apart of weekends). The intervention will include 6 minutes of watching a movie clip alternately showing a healthy man and a healthy woman at their sixties, walking while being filmed from various angles. Immediately after watching, the subject will perform 6 minutes of walking, under the experimenters supervision, but without his or hers intervention. Immediately following the walking, the whole procedure will be repeated (watching a clip and walking).
Intervention Type
Other
Intervention Name(s)
watching walk backward clip
Intervention Description
The control group will undergo 12 treatments of the same nature, but will watch the movie clip shown backwards, so that the people filmed will seem to walk backwards (it was established that watching a reversed action does not activate the MNS system activated by a regular execution of the activity [Celnik et al., 2008]), followed by 6 minutes of walking under the experimenters supervision, then watching the movie again and walking again.
Primary Outcome Measure Information:
Title
Smart step examination- Average weight on the hind foot and fore foot. Cycle - time (in seconds) from one initial contact to the other (on the same foot). Stance and swing average percentage of one walking cycle, Cadence
Time Frame
before the beginning of the intervention, at its end and then three months after its conclusion.
Secondary Outcome Measure Information:
Title
2. Two min. walking test. 3. Ten meter walking test. 4. An ABC questioner to determine the personal confidence in regards to walking.
Time Frame
before the beginning of the intervention, at its end and then three months after its conclusion.
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:
People after a first ischemic or hemorrhagic stroke, up to 60 days following the event.
A FAC (Functional Ambulation Category) score test result of 2 or 3, in order to ensure basic mobility, even if still requiring supervision.
A NIHSS (National Institutes of Health Stroke Scale) score of 3 to 18.
Patients suffering from the following will not be part of the study:
Significant neglect (a BIT score under 129 in the conventional tests).
Hemianopsy as determined upon a clinical examination by a rehabilitation physician.
Clarity of vision problem, determined upon an SC based examination.
Significant cognitive decline (a Mini mental test score of under 24).
Aphasia which prevents understanding the signing a Helsinki form.
Exclusion Criteria:
Patients participating in concurrent researches will not participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zeev Meiner, M.D.
Phone
97225844474
Email
meiner@hadassah.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeev meiner, M.D
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah University Hospital
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
The Influences of Watching a Movie Clip of Normal Walking on Measurable Walking Parameters Among Post-Brain-Stroke Patients as Opposed to the Influences of a Control Movie Clip Showing Backwards Walking
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