Status:

UNKNOWN

Development and Evaluation of a Novel Portable Robotic Gait Rehabilitation in Chronic Stroke

Lead Sponsor:

National University Hospital, Singapore

Collaborating Sponsors:

National University of Singapore

Conditions:

Stroke

Eligibility:

All Genders

50-90 years

Phase:

NA

Brief Summary

The aims of this study is to test the training effects of the robotic walker. This study will compare the effectiveness of 2 different types of gait training protocols in chronic stroke patients, 1) c...

Detailed Description

This will be a prospective single blind randomized control trial where investigators propose to recruit a maximum of 100 older chronic stroke patients (age 50 years to 90 years old) with mild to sever...

Eligibility Criteria

Inclusion

  • Patient is aged 50 years to 90 years old
  • More than 6 months from first ever stroke but within 5 years confirmed by CT or MRI Brain
  • Mild to severe unilateral motor weakness (hemiparesis has to be severe with lower extremity strength graded as 3 or less on the Medical Research Council scale in more than 2 muscle groups) and severity should be between 5 and 25 calculated according to National Institute of Health Stroke Scale
  • Significant gait deficits ( Functional Ambulation Category , FAC ≤ 4 )
  • Able to understand instructions and participate in rehabilitation
  • Spasticity: Modified Ashworth Scale (MAS) less than 4
  • Independent trunk control
  • Comfortable to walk without a walking aid

Exclusion

  • Patient undergoing any formal rehabilitation program
  • Multiple stroke
  • Intracranial bleeds
  • Any chronic disabling pathologies
  • Spasticity limiting lower extremity ROM to less than 80 %
  • Mini Mental State Examination (MMSE) score \< 24
  • Significant sensory deficit/ hemisensory neglect
  • Any recent surgeries including orthopedic
  • Active cancers or any other terminal illness
  • Significant orthostatic hypotension
  • Hip, knee and ankle arthrodesis
  • Severe vascular disorders in lower limbs
  • Having permanent pacemakers or ventriculoperitoneal shunt
  • Subject's weight \> 75kg

Key Trial Info

Start Date :

April 2 2018

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 10 2018

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT03444688

Start Date

April 2 2018

End Date

December 10 2018

Last Update

April 10 2018

Active Locations (1)

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Page 1 of 1 (1 locations)

1

National University Hospital

Singapore, Singapore, 119074

Development and Evaluation of a Novel Portable Robotic Gait Rehabilitation in Chronic Stroke | DecenTrialz