Assessing Special Features of Impaired Gait After Acquired Brain Injury With an Instrumented Treadmill

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Sheba Medical Center
Sponsor:
Information provided by (Responsible Party):
Dr. Manuel Zwecker MD, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01413321
First received: July 19, 2011
Last updated: December 26, 2012
Last verified: December 2012
  Purpose

Hemiparetic gait following acquired brain injury (ABI) is grossly characterized by decreased speed of walking, increased stance time on the unaffected side, and decreased stance time on the affected side.These abnormalities are associated with a complex pattern of dysfunction including muscle weakness, spasticity, impaired sensory-motor control, long-term mechanical changes in muscles and joints, and cognitive impairments e.g. attention.\ At this stage of our knowledge it is still unclear which kinetic and kinematic parameters of hemiparetic gait provide insight about the different components of the complex pattern of dysfunction.

A novel technique had been introduced in the Motion Laboratory of the Sheba Medical Center consisting of an ordinary treadmill that is equipped with a 'mat' of more than 5000 high-quality capacitive pressure/force sensors. This treadmill developed by "ZEBRIS" enables to analyze gait and roll-off patterns on the treadmill.

Aims of the study:

  1. To assess variability of data derived from the Zebris treadmill.
  2. To investigate stability of hemiparetic gait.
  3. To evaluate variability and relevant gait parameters taking place during recovery after acute ABI.
  4. To compare gait on ground with gait on treadmill.

Rationale of the study- Basic assumptions of the study:

  1. No significant change in gait parameters is expected in both groups including healthy controls and chronic ABI subjects in recurrent examination within one week period.
  2. Subacute ABI patients are found to be within the context of neurorehabilitative recovery due to brain plasticity. Therefore a change in gait parameters is expected within two consecutive examinations in the chosen time intervals.
  3. All measurements are subject to error which contributes to the variance of outcomes.

On the grounds of these assumptions:

A. Two consecutive examinations in both groups including healthy controls and chronic ABI subjects are intended to estimate the error in measured values.

B. Two consecutive examinations in the subacute ABI patient group are intended to estimate the contribution of neurorehabilitative recovery due to brain plasticity assessed with this unique research instrumentation.


Condition
Traumatic and/or Non-traumatic Brain Injury

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Reproducibility and Special Features of Hemiparetic Gait in People With Acquired Brain Injury (ABI) Assessed With an Instrumented Treadmill (Zebris)

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Quality of walking assessed by spatio-temporal gait parameters commonly used in gait laboratories. [ Time Frame: One predetermined gait session should last to 90 minutes. Data collection will be finished one year after the start of the study. Data analysis will be done up to 1 year after Data collection. Summarize of the study 6 months after Data analysis. ] [ Designated as safety issue: No ]

    Quality of walking: measured by quantifying temporal and spatial parameters, such as [Length of stance phase, Length of swing phase (swing time), Length of double support phase, time of step, Cadence, Step length, Stride].

    These parameters will be calculated from the ground reaction force in function of time.



Estimated Enrollment: 45
Study Start Date: December 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
SHABI
Subacute hemiparetic ABI subjects group
CHABI
Chronic hemiparetic ABI subjects group

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects will be recruited from inpatient and outpatient clinics at the Sheba Medical Center

Criteria

Inclusion Criteria:

  • Older than 18y, both healthy and hemiparetic participants.
  • Able to walk continuously for 6 min at their self-selected speed.
  • Normal subjects should be without any clinical history of diseases or injuries in the lower extremities.
  • Able to understand the eligibility requirements for participation in the study.

Exclusion Criteria:

  • Patients with more than one previous clinical stroke or other brain injury.
  • Peripheral artery disease with claudication.
  • Shortness of breath without exertion
  • Resting heart rate outside of the range of 55 to 85 bpm.
  • Resting blood pressure outside of the range of 90/60 to 170/90 mm Hg.
  • Medical and especially cardial conditions preventing walking for more than 10 minutes under normal velocity.
  • No additional major orthopedic or neuromuscular disorders preventing normal walking.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01413321

Contacts
Contact: Manuel Zwecker, MD **972 3 5303737 manuel.zwecker@sheba.health.gov.il

Locations
Israel
Sheba Medical Center Recruiting
Tel Hashomer, Ramat Gan, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Manuel Zwecker, MD Sheba Medical Center
  More Information

Publications:
Responsible Party: Dr. Manuel Zwecker MD, Senior physician, Department of Neurological Rehabilitation., Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01413321     History of Changes
Other Study ID Numbers: SHEBA-10-8315-MZ-CTIL
Study First Received: July 19, 2011
Last Updated: December 26, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Sheba Medical Center:
Brain Injuries
Post Traumatic Encephalopathy
TBI (Traumatic Brain Injury)
Cerebral Stroke
Vascular Accidents, Brain
Cerebrovascular Apoplexy
Cerebrovascular Accident
hemiparesis

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014