Comparing Effects of Conventional Neurorehabilitation With Exoskeleton With High-intensity Gait Training

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

Official title: Comparing Effects of Conventional Neurorehabilitation With Exoskeleton With High-intensity Gait Training on Gait, Balance, and Depression Following Stroke and the Impact of Social Determinants of Health and Depression on Patients' Adherence to Physical Therapy

Conditions

Stroke, Gait, Hemiplegic

Being tested

Exoskeleton mediated gait training, High intensity gait training

Keywords

health literacy, balance, compliance to therapy, gait function, high intensity gait training, exoskeleton

Medical subject headings

Stroke, Gait Disorders, Neurologic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Exoskeleton mediated gait trainingBehavioural

  Also called EksoGT-mediated gait training

  1 session of Forward Walking with EksoGT per week

  1 session of conventional neurorehabilitation intervention per week

  • Transfer training
  • Gait training
  • Balance (sitting/standing; static/dynamic)
  • Strength
  • Neuromuscular re-education
  • Orthotics
  • Positioning
  • Caregiver education
  • Assistive device
  • Wheelchair assessment and mobility
  • Endurance training

• High intensity gait trainingBehavioural

  2 sessions of High-Intensity Gait Training at a target heart rate of 60-80% of the maximum heart rate or target RPE of 15-18

  • Forward stepping practice
  • Backwards stepping practices
  • Sidestepping
  • Stairs
  • Balance and compliant surface training while walking
  • Propulsion
  • Lateral balance training
  • Stability training
  • Stance control training
  • Limb advancement

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Demographic Questionnaire

   Questions include age, sex, date of birth, race/ethnicity, total income during T the past 12 months, main occupation and when was the last work, language at home, marital status, education level, and if they take any antidepressants.

   Measured: Pre-intervention

2. Newest Vital Sign (NVS)

   The NVS is a 6-question screening tool that identifies participants' risk of low or limited health literacy (HL) based on interpreting an ice cream nutrition label.

   Measured: Pre-intervention

3. Multidimensional Scale of Perceived Social Support (MSPSS)

   The Multidimensional Scale of Perceived Social Support is a 12-item self-administered scale that measures social support. The total score for the MSPSS ranges from 12 to 84, with higher scores indicating higher levels of perceived social support.

   Measured: Pre-intervention

4. Patient Health Questionnaire (PHQ-9)

   The PHQ-9 is a self-administered depression screening tool with nine items. It has been reported that the PHQ-9 is the best-performing tool for screening for post-stroke depression.

   Measured: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)

5. 3-Meter Backwards Walk Test (3MBWT)

   The 3MBWT measures the time (in seconds) it takes for a participant to walk 3 meters backward, hence assessing a backward gait speed. Backward gait speed is used to evaluate neuromuscular control, proprioception, protective reflexes, fall risk, and balance. Use of assistive devices will be documented.

   Measured: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)

6. 6-Minute Walk Test

   The 6MWT assesses participants' aerobic capacity/endurance by recording the distance (in meters) that the participants walk in 6 minutes. Assistive devices may be used and will be documented.

   Measured: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)

7. 10-meter Walk Test

   The 10mWT assesses walking speed in meters/second (m/s) over a short distance (10m). Two trials are administered at the patient's comfortable walking speed, followed by 2 trials at their fast walking speed, per Physical Therapist's instruction. The 2 trials for each speed are then averaged and the 2 gait speeds (preferred and fast) are documented in m/s. Assistive devices may be used, and will be documented.

   Measured: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)

8. Muscle coactivation index

   Muscle coactivation index will be calculated based on the EMG signals from 8 leg muscles (bilateral tibialis anterior, medial gastrocnemius, rectus femoris, medial hamstring). Surface electromyographic recordings will be conducted during forward and backward walking tests.

   Measured: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)

9. Berg Balance Scale (BBS)

   The Berg Balance Scale is a 14-item clinician-rated measure that assesses static and balance in sitting and standing. It has a maximum score of 56 points. Each item is scored on a 5-point scale from 0 to 4, with 0 indicating the subject is unable to perform the task and 4 being the highest score.

   Measured: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)

10. Functional Gait Assessment (FGA)

    The FGA is used to assess postural stability during walking and assesses an individual's ability to perform multiple motor tasks while walking. The Functional Gait Assessment (FGA) is scored on a 4-point ordinal scale ranging from 0-3, with 0 indicating severe impairment and 3 indicating normal ambulation. The total score is calculated by summing all the items and ranges from 0-30, with lower scores indicating greater impairment.

    Measured: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)

11. Borg rating scale of Perceived Exertion

    The Borg Rating Scale of Perceived Exertion will be measured in all participants at the completion of 6 minute walk test. It measures exertion on a scale of 0 (no exertion or resting) to 10 (pushing oneself to the max).

    Measured: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted27 Jun 2024
2. Study start1 Oct 2024
3. Primary completion30 May 2025
4. Study completion30 May 2025

Why it stopped: Lack of participants

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for StrokeStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.