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Comparison of Different Treatment Methods for Gait Rehabilitation of Sub-Acute Post Stroke Patients With Dropped Foot

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01876030
First received: May 2, 2013
Last updated: November 3, 2013
Last verified: April 2013
  Purpose

The investigators hypothesize that the gait pattern of following the utilization of a functional electrical stimulation device will be much improved when compared to the effect of regular gait re-education with ankle-foot-orthosis (AFO) fitting in patients in early stages following stroke.


Condition Intervention
Dropped Foot
Device: FES

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Change in velocity of gait [ Time Frame: Baseline, 4 weeks and 12 week follwing baseline ] [ Designated as safety issue: No ]
    Measured in m/s and the change will be in %

  • Change in step length [ Time Frame: Baseline, 4 and 12 weeks following baseline ] [ Designated as safety issue: No ]
    Measured in cm and the change will be in %


Secondary Outcome Measures:
  • Gait symmetry [ Time Frame: Baseline, 4 and 12 weeks following baseline ] [ Designated as safety issue: No ]
    Calculated symmetry of stance duration, swing duration, double support duration, step length, base width, and foot progression

  • Muscle activity patterns [ Time Frame: Baseline, 4 and 12 weeks following baseline ] [ Designated as safety issue: No ]
    Surface electromyography (EMG) electrodes will be attached to 6 muscles for evaluation of dynamic muscle activation pattern during gait without the intervention. Specifically, we will monitor the medial gastrocnemius, soleus and tibialis anterior, bilaterally.

  • Functional assessment [ Time Frame: At baseline, 4 and 12 weeks following baseline ] [ Designated as safety issue: No ]

    Selective motor control during dorsiflexion will be tested with and without flexed knee according to the classification of three levels: normal, impaired, and unable. This test will be utilized for matching of the test group and control group. Physical evaluation will be conducted to assess the muscle tonus of the gastrocnemius, tibialis anterior and quadriceps according to Ashwart scale. Passive joint range of motion will also be assessed.

    Functional evaluation of each subject will be accomplished using the 10-meter walk. The Functional Ambulation Classification (FAC) will also be applied in order to obtain a patient prognosis level with regard to ambulation.

    Time up and Go (TUG) test will be performed in the in gait laboratory so that the performance of the subjects during the trials can be videotaped.



Estimated Enrollment: 40
Study Start Date: June 2013
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FES
All subjects will receive a 15-30 minutes a day treatment for 5 days a week. When the subjects achieves the ability to walk with supervision, but with no physical assistance, safely and consistently during the physiotherapy sessions, then either the FES will be provided to the subject to allow ongoing gait practice with the nursing staff in the ward environment. After discharge, the assistive device will be provided for home usage till the end of the research.
Device: FES
Other Names:
  • Mygait
  • FES
No Intervention: Conventional
Treated with regular gait re-education with or without AFO fitting. All subjects will receive a 15-30 minutes a day treatment for 5 days a week. When the subjects achieves the ability to walk with supervision, but with no physical assistance, safely and consistently during the physiotherapy sessions, then either the AFO will be provided to the subject to allow ongoing gait practice with the nursing staff in the ward environment. After discharge, the assistive device will be provided for home usage till the end of the research.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Sub-acute stroke patients suffering a first stroke with clinical presentation, according to the WHO definitions
  • Patients suffering from unilateral foot drop
  • Independent ambulation before the stroke
  • Cognitive and cooperative ability to follow simple instructions
  • Neurological condition severity mild to moderate (between 3 and 15, according to the National Institutes of Health Stroke Scale; NIHSS).
  • Ability to walk with or without a walking aid (cane, walker), with or without assistance. Functional Ambulation Classification (FAC) of at least 2
  • Independently capable to understand an informed consent form.

Exclusion Criteria:

  • Cognitive disorders preventing the subject from understanding the trial protocol or following the researcher's instructions
  • Orthopaedic injury to the paretic or non-paretic limbs
  • Motor disability due to neurological diagnosis, e.g. multiple sclerosis, cerebral palsy, spinal cord injury, and Parkinson
  • Peripheral injury of the peroneal nerve or sciatic nerve
  • Pregnant or nursing females
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01876030

Contacts
Contact: Sigal Portnoy, PhD 0097225844492 sigalp@hadassah.org.il
Contact: Hadas Lemberg, PhD 00 972 2 6777572 lhadas@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Recruiting
Jerusalem, Israel, 91120
Contact: Sigal Portnoy, PhD    0097225844492    sigalp@hadassah.org.il   
Contact: Hadas Lemberg, PhD    00 972 2 6777572    lhadas@hadassah.org.il   
Sub-Investigator: Sigal Portnoy, PhD         
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01876030     History of Changes
Other Study ID Numbers: MyGait-HMO-CTIL
Study First Received: May 2, 2013
Last Updated: November 3, 2013
Health Authority: Israel: Ministry of Health - Director General

Keywords provided by Hadassah Medical Organization:
Functional electrical stimulation (FES)
Sub acute stroke
Gait analysis

ClinicalTrials.gov processed this record on November 25, 2014