Assessing Special Features of Impaired Gait After Acquired Brain Injury With an Instrumented Treadmill - Full Text View

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:

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

Rationale of the study- Basic assumptions of the study:

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.
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.
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:

MedlinePlus related topics: Traumatic Brain Injury

U.S. FDA Resources

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 2015
Estimated Primary Completion Date:	December 2015 (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:

Lehmann JF, Condon SM, Price R, deLateur BJ. Gait abnormalities in hemiplegia: their correction by ankle-foot orthoses. Arch Phys Med Rehabil. 1987 Nov;68(11):763-71.

Olney SJ, Monga TN, Costigan PA. Mechanical energy of walking of stroke patients. Arch Phys Med Rehabil. 1986 Feb;67(2):92-8.

Peat M, Dubo HI, Winter DA, Quanbury AO, Steinke T, Grahame R. Electromyographic temporal analysis of gait: hemiplegic locomotion. Arch Phys Med Rehabil. 1976 Sep;57(9):421-5.

Knutsson E, Richards C. Different types of disturbed motor control in gait of hemiparetic patients. Brain. 1979 Jun;102(2):405-30.

Olney SJ, Griffin MP, Monga TN, McBride ID. Work and power in gait of stroke patients. Arch Phys Med Rehabil. 1991 Apr;72(5):309-14.

Knutsson E. Gait control in hemiparesis. Scand J Rehabil Med. 1981;13(2-3):101-8.

Knutsson E, Mårtensson A. Dynamic motor capacity in spastic paresis and its relation to prime mover dysfunction, spastic reflexes and antagonist co-activation. Scand J Rehabil Med. 1980;12(3):93-106.

Dietz V, Berger W. Normal and impaired regulation of muscle stiffness in gait: a new hypothesis about muscle hypertonia. Exp Neurol. 1983 Mar;79(3):680-7.

Knutsson E. Can gait analysis improve gait training in stroke patients. Scand J Rehabil Med Suppl. 1994;30:73-80. Review.


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:	January 16, 2015
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 Craniocerebral Trauma	Nervous System Diseases Trauma, Nervous System Wounds and Injuries

ClinicalTrials.gov processed this record on March 03, 2015