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Completed

NCT Number: NCT02680691

Robot Assisted Gait Training in Patients With Infratentorial Stroke

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

Completed

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Rehabilitation Center

Seoul, 142884, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Robot, then conventional training

Other

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

Conventional, then robot training

Other

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

Primary outcomes

  1. Change From Baseline in Berg Balance Scale at 4 Weeks

    Time frame: Baseline and 4 weeks from baseline

    Berg Balance Scale assess the functional balance ability of participants with observation of 14 tasks, representing functional movements common in daily life

Secondary outcomes

  1. Berg Balance Scale

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

    Berg Balance Scale assess the functional balance ability of participants with observation of 14 tasks, representing functional movements common in daily life

  2. Trunk impairment scale

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

    Trunk impairment scale performs to evaluate the sitting balance and trunk control ability examining static sitting balance, dynamic sitting balance, and coordination

  3. Functional Ambulation Category

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

    Categorizes patients according to basic motor skills necessary for functional ambulation. It represents the status of ambulation

  4. 10m walk test

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

    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

  5. Fugl-Meyer Assessment

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

    Fugl-Meyer Assessment uses to examine the motor function and coordination of affected lower extremity

  6. Korean version of Falls efficacy scale

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

    Asseses perception of balance and stability during activities of daily living Assesses fear of falling in the elderly population

  7. Scale for the assessment and rating of ataxia

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

    Scale for the assessment and rating for infratentorial stroke

  8. Balance test using force plate

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

    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.

Sponsors and collaborators

Lead sponsor

National Rehabilitation Center, Seoul, Korea

Other Gov

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 11, 2016
Registry last updated
Mar 5, 2018

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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