Assessing Special Features of Impaired Gait After Acquired Brain Injury With an Instrumented Treadmill
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|ClinicalTrials.gov Identifier: NCT01413321|
Recruitment Status : Completed
First Posted : August 10, 2011
Last Update Posted : October 5, 2017
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 or disease|
|Traumatic and/or Non-traumatic Brain Injury|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||35 participants|
|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|
Subacute hemiparetic ABI subjects group
Chronic hemiparetic ABI subjects group
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01413321
|Sheba Medical Center|
|Tel HaShomer, Israel, 52621|
|Principal Investigator:||Manuel Zwecker, MD||Sheba Medical Center|