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CompletedNCT02680691Updated Mar 5, 2018

Robot Assisted Gait Training in Patients With Infratentorial Stroke

An interventional study of Robot, then conventional training and Conventional, then robot training in Stroke, sponsored by National Rehabilitation Center, Seoul, Korea. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-05.

Sponsored by National Rehabilitation Center, Seoul, Korea · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Stroke

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Keywords

  • infratentorial stroke
  • robot
  • postural balance
  • Rehabilitation
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 19 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

National Rehabilitation Center, Seoul, Korea is the lead sponsor of 20 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with infratentorial stroke
  • Cognitively intact enough to understand and follow the instructions from the investigator

Exclusion criteria

Exclusion Criteria:

  • chronic neurological pathology
  • orthopedic injuries
  • femur lengths of less than 34cm
  • severely limited range of lower extremity joint motion
  • medical instability
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    Robot, then conventional training

    Robot assisted gait training 4 weeks after conventional gait training

    Other: Robot, then conventional training

  • Active comparator
    Conventional, then robot training

    Conventional gait training 4 weeks after robot assisted gait training

    Other: Conventional, then robot training

Interventions

  • OtherRobot, then conventional training

    Robot assisted gait training from the baseline, then conventional gait training at 4 weeks after baseline

  • OtherConventional, then robot training

    Conventional gait training from the baseline, then robot assisted gait training at 4 weeks after baseline

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline and 4 weeks from baseline

Secondary outcomes

  1. 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

    Time frame: Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline

  2. 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

    Time frame: Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline

  3. Functional Ambulation Category

    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

  4. 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

    Time frame: Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline

  5. Fugl-Meyer Assessment

    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

  6. 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

    Time frame: Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline

  7. Scale for the assessment and rating of ataxia

    Scale for the assessment and rating for infratentorial stroke

    Time frame: Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline

  8. 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.

    Time frame: Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline

07

Study locations

1 site
  • National Rehabilitation Center
    Seoul, 142884, Korea, Republic of
08

References and documents

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. PubMed 31358017 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02680691
Lead sponsor
National Rehabilitation Center, Seoul, Korea
Responsible party
Joon-Ho Shin (Team manager, National Rehabilitation Center, Seoul, Korea) — Principal investigator
First posted
Feb 11, 2016
Start date
Apr 2015
Primary completion
Mar 2016
Completion
Dec 2016
Last update
Mar 5, 2018

Study contacts

Joon-Ho Shin, MS
principal investigator · National Rehabilitation Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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