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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease
Traumatic and/or Non-traumatic Brain Injury

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Study Design

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Study Type :	Observational
Actual Enrollment :	35 participants
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)
Actual Study Start Date :	December 2011
Actual Primary Completion Date :	August 2017
Actual Study Completion Date :	August 2017

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
SHABI; Subacute hemiparetic ABI subjects group
CHABI; Chronic hemiparetic ABI subjects group

Outcome Measures

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Primary Outcome Measures :

1. 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. ]

   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.

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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Locations

Israel
Sheba Medical Center
Tel HaShomer, Israel, 52621

Sponsors and Collaborators

Sheba Medical Center

Investigators

Principal Investigator:	Manuel Zwecker, MD	Sheba Medical Center

More Information

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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
First Posted:	August 10, 2011
Last Update Posted:	October 5, 2017
Last Verified:	October 2017

Keywords provided by Dr. Manuel Zwecker MD, 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:

Wounds and Injuries; Brain Injuries; Brain Diseases; Central Nervous System Diseases	Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System