Robot Assisted Gait Training in Patients With Infratentorial Stroke

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

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

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: Robot, then conventional training; Other: Conventional, then robot training

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 142884
    • National Rehabilitation Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robot, then conventional training; Robot assisted gait training 4 weeks after conventional gait training	Other: Robot, then conventional training; Robot assisted gait training from the baseline, then conventional gait training at 4 weeks after baseline
Active Comparator: Conventional, then robot training; Conventional gait training 4 weeks after robot assisted gait training	Other: Conventional, then robot training; Conventional gait training from the baseline, then robot assisted gait training at 4 weeks after baseline

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

Collaborators and Investigators

• Sponsor: National Rehabilitation Center, Seoul, Korea

Publications and helpful links

General Publications

• 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.

Helpful Links

• Site of the present study

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: February 9, 2016
• First Submitted That Met QC Criteria: February 9, 2016
• First Posted (Estimate): February 11, 2016

Study Record Updates

• Last Update Posted (Actual): March 5, 2018
• Last Update Submitted That Met QC Criteria: March 1, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Rehabilitation; robot; infratentorial stroke; postural balance
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: NRC-2015-01-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No