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

June 2, 2010 updated by: Hadassah Medical Organization

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • Hadassah University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
before the beginning of the intervention, at its end and then three months after its conclusion.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
before the beginning of the intervention, at its end and then three months after its conclusion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Investigators

  • Principal Investigator: Zeev meiner, M.D, Hadassah Medical Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

September 6, 2009

First Submitted That Met QC Criteria

September 23, 2009

First Posted (Estimate)

September 24, 2009

Study Record Updates

Last Update Posted (Estimate)

June 3, 2010

Last Update Submitted That Met QC Criteria

June 2, 2010

Last Verified

September 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0303-09-HMO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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