Robot Assisted Gait Training in Patients With Infratentorial Stroke

Study Overview
=================
Brief Summary
-----------------
The Effect of Robot Assisted Gait Training in Patients With Infratentorial Stroke

Detailed Description
-----------------
The hypothesis is to determine the robotic gait training would be better than conventional therapy regarding the postural balance.

Official Title
-----------------
The Effect of Robot Assisted Gait Training in Patients With Infratentorial Stroke

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Other: Robot, then conventional training
* Other: Conventional, then robot training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with infratentorial stroke Cognitively intact enough to understand and follow the instructions from the investigator Exclusion Criteria: chronic neurological pathology orthopedic injuries femur lengths of less than 34cm severely limited range of lower extremity joint motion medical instability

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot, then conventional training<br>Robot assisted gait training 4 weeks after conventional gait training | Other: Robot, then conventional training<br>* Robot assisted gait training from the baseline, then conventional gait training at 4 weeks after baseline<br>|
| Active Comparator: Conventional, then robot training<br>Conventional gait training 4 weeks after robot assisted gait training | Other: Conventional, then robot training<br>* Conventional gait training from the baseline, then robot assisted gait training at 4 weeks after baseline<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Berg Balance Scale at 4 Weeks | Berg Balance Scale assess the functional balance ability of participants with observation of 14 tasks, representing functional movements common in daily life | Baseline and 4 weeks from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Berg Balance Scale | Berg Balance Scale assess the functional balance ability of participants with observation of 14 tasks, representing functional movements common in daily life | Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline | 
| Trunk impairment scale | Trunk impairment scale performs to evaluate the sitting balance and trunk control ability examining static sitting balance, dynamic sitting balance, and coordination | Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline | 
| Functional Ambulation Category | Categorizes patients according to basic motor skills necessary for functional ambulation. It represents the status of ambulation | Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline | 
| 10m walk test | 10m walk test is used to examine gait speed, in which participant was asked to walk on a 14 meter of walkway wearing harness with two conditions; with the fastest speed or with self-selected comfortable speed | Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline | 
| Fugl-Meyer Assessment | Fugl-Meyer Assessment uses to examine the motor function and coordination of affected lower extremity | Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline | 
| Korean version of Falls efficacy scale | Asseses perception of balance and stability during activities of daily living Assesses fear of falling in the elderly population | Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline | 
| Scale for the assessment and rating of ataxia | Scale for the assessment and rating for infratentorial stroke | Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline | 
| Balance test using force plate | Each subject performs the following four tasks resembling Romberg test: standing with their feet positioning with the distance between their shoulders with eyes open (FSEO) or closed (FSEC), and standing with their feet together with eyes open (FTEO) or closed (FTEC). Each task is performed for 20 seconds and repeat for three times. | Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infratentorial stroke, robot, postural balance, Rehabilitation