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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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ClinicalTrials.gov Identifier: NCT00983450
Recruitment Status : Unknown
Verified September 2009 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : September 24, 2009
Last Update Posted : June 3, 2010
Sponsor:
Information provided by:
Hadassah Medical Organization

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.


Condition or disease Intervention/treatment Phase
Stroke Other: watching a normal walking clip Other: watching walk backward clip Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : October 2009
Estimated Primary Completion Date : December 2010

Arm Intervention/treatment
Experimental: study group
People after a first ischemic or hemorrhagic stroke, up to 60 days following the event.
Other: watching a normal walking clip
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).

Experimental: CONTROL
People after a first ischemic or hemorrhagic stroke, up to 60 days following the event.
Other: watching walk backward clip
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 Measures :
  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 [ Time Frame: before the beginning of the intervention, at its end and then three months after its conclusion. ]

Secondary Outcome Measures :
  1. 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. ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00983450


Contacts
Contact: Zeev Meiner, M.D. 97225844474 meiner@hadassah.org.il

Locations
Israel
Hadassah University Hospital Recruiting
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Zeev meiner, M.D Hadassah Medical Organization

Responsible Party: Dr. Zeev Meiner, Hadassah Medical Center
ClinicalTrials.gov Identifier: NCT00983450     History of Changes
Other Study ID Numbers: 0303-09-HMO
First Posted: September 24, 2009    Key Record Dates
Last Update Posted: June 3, 2010
Last Verified: September 2009

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Adrenocorticotropic Hormone
Melanocyte-Stimulating Hormones
beta-Endorphin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action