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Robot Assisted Gait Training in Patients With Infratentorial Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Robot, then conventional training
Conventional, then robot training
Sponsored by
National Rehabilitation Center, Seoul, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring infratentorial stroke, robot, postural balance, Rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Rehabilitation Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robot, then conventional training

Conventional, then robot training

Arm Description

Robot assisted gait training 4 weeks after conventional gait training

Conventional gait training 4 weeks after robot assisted gait training

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
Functional Ambulation Category
Categorizes patients according to basic motor skills necessary for functional ambulation. It represents the status of ambulation
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
Fugl-Meyer Assessment
Fugl-Meyer Assessment uses to examine the motor function and coordination of affected lower extremity
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
Scale for the assessment and rating of ataxia
Scale for the assessment and rating for infratentorial stroke
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.

Full Information

First Posted
February 9, 2016
Last Updated
March 1, 2018
Sponsor
National Rehabilitation Center, Seoul, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT02680691
Brief Title
Robot Assisted Gait Training in Patients With Infratentorial Stroke
Official Title
The Effect of Robot Assisted Gait Training in Patients With Infratentorial Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Rehabilitation Center, Seoul, Korea

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
infratentorial stroke, robot, postural balance, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Robot, then conventional training
Arm Type
Experimental
Arm Description
Robot assisted gait training 4 weeks after conventional gait training
Arm Title
Conventional, then robot training
Arm Type
Active Comparator
Arm Description
Conventional gait training 4 weeks after robot assisted gait training
Intervention Type
Other
Intervention Name(s)
Robot, then conventional training
Intervention Description
Robot assisted gait training from the baseline, then conventional gait training at 4 weeks after baseline
Intervention Type
Other
Intervention Name(s)
Conventional, then robot training
Intervention Description
Conventional gait training from the baseline, then robot assisted gait training at 4 weeks after baseline
Primary Outcome Measure Information:
Title
Change From Baseline in Berg Balance Scale at 4 Weeks
Description
Berg Balance Scale assess the functional balance ability of participants with observation of 14 tasks, representing functional movements common in daily life
Time Frame
Baseline and 4 weeks from baseline
Secondary Outcome Measure Information:
Title
Berg Balance Scale
Description
Berg Balance Scale assess the functional balance ability of participants with observation of 14 tasks, representing functional movements common in daily life
Time Frame
Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Title
Trunk impairment scale
Description
Trunk impairment scale performs to evaluate the sitting balance and trunk control ability examining static sitting balance, dynamic sitting balance, and coordination
Time Frame
Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Title
Functional Ambulation Category
Description
Categorizes patients according to basic motor skills necessary for functional ambulation. It represents the status of ambulation
Time Frame
Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Title
10m walk test
Description
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
Time Frame
Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Title
Fugl-Meyer Assessment
Description
Fugl-Meyer Assessment uses to examine the motor function and coordination of affected lower extremity
Time Frame
Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Title
Korean version of Falls efficacy scale
Description
Asseses perception of balance and stability during activities of daily living Assesses fear of falling in the elderly population
Time Frame
Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Title
Scale for the assessment and rating of ataxia
Description
Scale for the assessment and rating for infratentorial stroke
Time Frame
Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Title
Balance test using force plate
Description
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.
Time Frame
Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joon-Ho Shin, MS
Organizational Affiliation
National Rehabilitation Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Rehabilitation Center
City
Seoul
ZIP/Postal Code
142884
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31358017
Citation
Kim HY, Shin JH, Yang SP, Shin MA, Lee SH. Robot-assisted gait training for balance and lower extremity function in patients with infratentorial stroke: a single-blinded randomized controlled trial. J Neuroeng Rehabil. 2019 Jul 29;16(1):99. doi: 10.1186/s12984-019-0553-5.
Results Reference
derived
Links:
URL
http://nrc.go.kr
Description
Site of the present study

Learn more about this trial

Robot Assisted Gait Training in Patients With Infratentorial Stroke

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