Assessing Special Features of Impaired Gait After Acquired Brain Injury With an Instrumented Treadmill
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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 |
|---|
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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) |
- 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 |
Subjects will be recruited from inpatient and outpatient clinics at the Sheba Medical Center
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| Contact: Manuel Zwecker, MD | **972 3 5303737 | manuel.zwecker@sheba.health.gov.il |
| Israel | |
| Sheba Medical Center | Recruiting |
| Tel Hashomer, Ramat Gan, Israel, 52621 | |
| 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 June 18, 2013