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
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2009
CompletedFirst Posted
Study publicly available on registry
September 24, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedJune 3, 2010
September 1, 2009
1.2 years
September 6, 2009
June 2, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
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
before the beginning of the intervention, at its end and then three months after its conclusion.
Secondary Outcomes (1)
2. Two min. walking test. 3. Ten meter walking test. 4. An ABC questioner to determine the personal confidence in regards to walking.
before the beginning of the intervention, at its end and then three months after its conclusion.
Study Arms (2)
study group
EXPERIMENTALPeople after a first ischemic or hemorrhagic stroke, up to 60 days following the event.
CONTROL
EXPERIMENTALPeople after a first ischemic or hemorrhagic stroke, up to 60 days following the event.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients participating in concurrent researches will not participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hadassah University Hospital
Jerusalem, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zeev meiner, M.D
Hadassah Medical Organization
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 6, 2009
First Posted
September 24, 2009
Study Start
October 1, 2009
Primary Completion
December 1, 2010
Last Updated
June 3, 2010
Record last verified: 2009-09