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Completed

NCT Number: NCT02569190

Effect of Robot-assisted Gait Training on Brain Reorganization in Hemiplegic Patients

Purpose: To evaluate the effect of robotic gait therapy for brain reorganization in hemiplegia patients.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Veterans Health Service Medical Center

Seoul, Gangdong-gu, 05368, South Korea

About this study

This study designed an interventional pre-post compared clinical study. The subjects received conventional physical therapy with Walkbot training (3 sessions per week for 7 weeks, 20 session). Before and after intervention all subjects evaluated using diffusion tensor imaging and clinical outcome measurements.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • First stroke attack
  • Within 3 months after stroke onset
  • Supratentorial stroke
  • Unilateral stroke

Exclusion criteria

  • Bilateral stroke
  • infratentorial stroke
  • Cognitive disabilities or serious psychiatric illness.
  • Difficulty in walking due to orthopedic problems.

Treatment and study plan

Walkbot

Device

Robot assisted gait training

Primary outcomes

  1. Change from baseline fraction anisotropy of corticoreticular tract in Diffusion tensor imaging 8 weeks after the first day of intervention

    Time frame: at the first day of intervention and 8 weeks after the first day

Secondary outcomes

  1. Functional ambulation category

    Time frame: at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day

    The functional ambulation category was designed to examine the levels of assistance required during a 15m walk. Six categories are included in the functional ambulation category: 0 (non-ambulatory), 1 (needs continuous support from one person), 2 (needs intermittent support from one person), 3 (needs only verbal supervision), 4 (help is required on stairs and uneven surfaces), and 5 (can walk independently anywhere).

  2. Fugl-meyer assessment

    Time frame: at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day

  3. Medical research council

    Time frame: at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day

    The medical research council was designed to examine the muscle strength. Six categories are included in the medical research council: 5 (muscle contracts normally against full resistance), 4 (muscle strength is reduced but muscle contraction can still move joint against resistance), 3 (muscle strength is further reduced such that the joint can be moved only against gravity with the examiner's resistance completely removed. As an example, the elbow can be moved from full extension to full flexion starting with the arm hanging down at the side), 2 (muscle can move only if the resistance of gravity is removed. As an example, the elbow can be fully flexed only if the arm is maintained in a horizontal plane), 1 (only a trace or flicker of movement is seen or felt in the muscle or fasciculations are observed in the muscle) and 0 (no movement is observed)

  4. Trunk control test

    Time frame: at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day

Sponsors and collaborators

Lead sponsor

Veterans Health Service Medical Center, Seoul, Korea

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 6, 2015
Registry last updated
Apr 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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