Comparison of Different Treatment Methods for Gait Rehabilitation of Sub-Acute Post Stroke Patients With Dropped Foot
|ClinicalTrials.gov Identifier: NCT01876030|
Recruitment Status : Unknown
Verified April 2013 by Hadassah Medical Organization.
Recruitment status was: Recruiting
First Posted : June 12, 2013
Last Update Posted : May 3, 2016
|Condition or disease||Intervention/treatment||Phase|
|Dropped Foot||Device: FES||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||June 2017|
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.
Other Name: Mygait
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.
- Change in velocity of gait [ Time Frame: Baseline, 4 weeks and 12 week follwing baseline ]Measured in m/s and the change will be in %
- Change in step length [ Time Frame: Baseline, 4 and 12 weeks following baseline ]Measured in cm and the change will be in %
- Gait symmetry [ Time Frame: Baseline, 4 and 12 weeks following baseline ]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 ]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 ]
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01876030
|Contact: Sigal Portnoy, PhDfirstname.lastname@example.org|
|Contact: Hadas Lemberg, PhD||00 972 2 email@example.com|
|Hadassah Medical Organization||Recruiting|
|Jerusalem, Israel, 91120|
|Contact: Sigal Portnoy, PhD 0097225844492 firstname.lastname@example.org|
|Contact: Hadas Lemberg, PhD 00 972 2 6777572 email@example.com|
|Sub-Investigator: Sigal Portnoy, PhD|