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

NCT01413321 | Completed

• 1 other identifier: SHEBA-10-8315-MZ-CTIL
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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. 1.To assess variability of data derived from the Zebris treadmill.
2. 2.To investigate stability of hemiparetic gait.
3. 3.To evaluate variability and relevant gait parameters taking place during recovery after acute ABI.
4. 4.To compare gait on ground with gait on treadmill.
5. 5.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.
6. 6.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.
7. 7.All measurements are subject to error which contributes to the variance of outcomes.

Conditions

Traumatic and/or Non-traumatic Brain Injury

Keywords

Brain Injuries; Post Traumatic Encephalopathy; TBI (Traumatic Brain Injury); Cerebral Stroke; Vascular Accidents, Brain; Cerebrovascular Apoplexy; Cerebrovascular Accident; hemiparesis

Outcome Measures

Primary Outcomes (1)

• Quality of walking assessed by spatio-temporal gait parameters commonly used in gait laboratories.

  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.

  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.

Study Arms (2)

SHABI

Subacute hemiparetic ABI subjects group

CHABI

Chronic hemiparetic ABI subjects group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

Related Publications (9)

• 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.

  PMID: 3675173 BACKGROUND

• Olney SJ, Monga TN, Costigan PA. Mechanical energy of walking of stroke patients. Arch Phys Med Rehabil. 1986 Feb;67(2):92-8. doi: 10.1016/0003-9993(86)90109-7.

  PMID: 3954572 BACKGROUND

• 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.

  PMID: 962569 BACKGROUND

• Knutsson E, Richards C. Different types of disturbed motor control in gait of hemiparetic patients. Brain. 1979 Jun;102(2):405-30. doi: 10.1093/brain/102.2.405.

  PMID: 455047 BACKGROUND

• 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.

  PMID: 2009047 BACKGROUND

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

  PMID: 7345566 BACKGROUND

• Knutsson E, Martensson 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.

  PMID: 7209447 BACKGROUND

• 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. doi: 10.1016/0014-4886(83)90032-8.

  PMID: 6825758 BACKGROUND

• Knutsson E. Can gait analysis improve gait training in stroke patients. Scand J Rehabil Med Suppl. 1994;30:73-80. No abstract available.

  PMID: 7886431 BACKGROUND

MeSH Terms

Conditions

Brain Injuries; Chronic Traumatic Encephalopathy; Brain Injuries, Traumatic; Stroke; Paresis

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Brain Injury, Chronic; Neurodegenerative Diseases; Brain Damage, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Manuel Zwecker, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior physician, Department of Neurological Rehabilitation.

Study Record Dates

• First Submitted: July 19, 2011
• First Posted: August 10, 2011
• Study Start: December 1, 2011
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: October 5, 2017

Record last verified: 2017-10

Locations

IL (1)